Newsroom Bayer

Monsanto unanimously wins first Roundup™ trial since U.S. Supreme Court decision

Fri, 30 Oct 2026 02:02:43 +0100

St. Louis, October 29, 2026 – A Missouri Circuit Court jury today reached a unanimous defense verdict in favor of Monsanto in the three-plaintiff case of Theresa Aretino, et al. v. Monsanto Company, the first Roundup™ trial to take place since the U.S. Supreme Court’s landmark ruling in Monsanto v. Durnell. The jury found for Monsanto on the design defect, fraud and negligence claims that each of the three plaintiffs pursued at trial following the Supreme Court’s favorable decision in Durnell, which preempted their failure-to-warn claims.

“We are pleased with the jury’s favorable verdict for Monsanto validating our belief that there is no evidence to prove design defect, fraud or negligence claims in the Roundup™ litigation,” said Bill Dodero, U.S. General Counsel and Global Head of Litigation. “This verdict should send a strong signal that plaintiffs who wish to pursue claims in the court system following the Durnell ruling will face significant challenges both in demonstrating they have viable claims and putting forth the necessary evidence to prove them in court.”

The first trial following Durnell

In June 2026, the U.S. Supreme Court issued a landmark ruling in the Durnell Roundup™ case, affirming that the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) expressly preempts state law claims based on failure-to-warn theories when the Environmental Protection Agency (EPA) has made a definitive determination on product safety. These claims have been a central theory in the Roundup™ litigation to date. With failure-to-warn claims no longer available, the Aretino plaintiffs pursued design defect and negligence claims. The verdict marks the first time a court has tested the sufficiency of evidence to support design defect and negligence claims at trial in the post-Durnell landscape.

Glyphosate’s safety

Glyphosate remains one of the most studied agricultural tools in history. The overwhelming weight of scientific evidence and the consensus of regulatory bodies and their scientific assessments worldwide support the safety of glyphosate-based herbicides when used as directed. The U.S. EPA has repeatedly and unequivocally determined that glyphosate is not likely to be carcinogenic and has consistently approved Roundup™ labels that contain no cancer warnings.

The company will continue to back the safety of its glyphosate-based herbicides – critical tools that farmers rely on to produce affordable food and feed the world – and will vigorously defend its products in any remaining litigation.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Asundexian first Factor XIa inhibitor approved in China for stroke risk reduction after priority review

Mon, 26 Oct 2026 09:14:57 +0100

Berlin, October 26, 2026 – Bayer announced today that China’s National Medical Products Administration (NMPA) has granted marketing authorization for asundexian, under the brand name Sunharbo^®. Asundexian, 50 mg, a selective, once-daily oral Factor XIa inhibitor (FXIa), is indicated to reduce the risk of stroke in adults after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). Sunharbo^®(asundexian) is the first FXIa inhibitor approved worldwide.

In China, stroke is the leading cause of death and disability. Between 2010 and 2021, the prevalence of ischemic stroke increased by 10% to more than 20 million ischemic stroke cases in China. Globally, approximately 1 in 10 non-cardioembolic ischemic stroke survivors experience another stroke within one year, even with available secondary stroke prevention strategies.

“With the approval of asundexian, we have reached an important milestone and are proud soon to be able to offer physicians in China a new treatment option for stroke survivors after a non-cardioembolic ischemic stroke or high‑risk transient ischemic attack. This enables us to address an unmet need with limited therapeutic advances over the past two decades," said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer`s Pharmaceuticals Division. "We are working with stakeholders and medical communities to support equitable and timely access for eligible patients in China."

Asundexian has been submitted for marketing authorization in additional markets around the world. These applications are currently under review, while Bayer continues to work with health authorities worldwide to bring asundexian to patients in other regions.

Key Clinical Trial Findings Supporting Approval

The approval by China’s National Medical Products Administration (NMPA) is based on positive data from the pivotal, global Phase III OCEANIC-STROKE study, the first successfully completed Phase III study of a Factor XIa inhibitor in combination with dual antiplatelet therapy (DAPT) / single antiplatelet therapy (SAPT) demonstrating superiority in reducing ischemic stroke, compared to DAPT/SAPT alone. The incidence of all bleeding events was similar between the two treatment groups, in patients after a non-cardioembolic stroke or high-risk TIA. Key findings demonstrated:

Asundexian 50 mg in combination with DAPT/SAPT, significantly reduced ischemic stroke by 26% in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA), compared to DAPT/SAPT alone.
The incidence of all bleeding events was similar between the two treatment groups.
Treatment effect for the primary endpoint was consistent across key subgroups (including age, sex, type of index event, non-cardioembolic stroke subtypes, stroke severity, and planned antiplatelet therapy) supporting its potential use across a broad patient population.
The full results from OCEANIC-STROKE have been published in The New England Journal of Medicine

About OCEANIC-STROKE
The Phase III OCEANIC-STROKE study investigated the efficacy and safety of the selective, once-daily oral Factor XIa inhibitor asundexian 50 mg in combination with DAPT/SAPT, compared to DAPT/SAPT alone, for risk reduction of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA). OCEANIC-STROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH (International Society on Thrombosis and Hemostasis) major bleeding.

About FXIa Inhibitors and Asundexian
Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. However, FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.

Asundexian is the first approved FXIa inhibitor worldwide. It selectively inhibits FXIa, allowing to reduce pathological clot formation, with similar incidence of all bleeding events between the two treatment groups, by uncoupling hemostasis from pathological thrombosis.

About Bayer’s Commitment in Cardiovascular and Cerebrovascular Medicine
Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. The company has set a clear focus on developing therapies to treat such diseases (e.g. stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Darolutamide plus ADT and radiation therapy reduces risk of metastasis or death by 58% in prostate cancer patients at high risk of recurrence

Sat, 24 Oct 2026 08:30:01 +0200

Berlin, October 24, 2026 – New late-breaking data to be presented today at the European Society for Medical Oncology (ESMO) Congress 2026 will show that adding Bayer’s androgen receptor inhibitor (ARi), darolutamide, to standard-of-care androgen deprivation therapy (ADT) and locoregional radiation therapy (RT), significantly improves metastasis-free survival based on conventional imaging (MFS-CI) in prostate cancer patients with high risk of recurrence compared to placebo. Darolutamide is currently not approved for this treatment setting. These data will be presented at Presidential Symposium I at the ESMO Congress 2026 (LBA4, Saturday 24 October, 16:30 CET).

At a median follow-up of 3.8 years, the interim analysis demonstrated a 58% reduction in the risk of metastasis or death with darolutamide plus ADT and RT compared with placebo plus ADT and RT (hazard ratio [HR] 0.42; 95% CI: 0.27–0.66; p=0.0001). The 4-year metastasis-free survival rate was 95% for patients receiving darolutamide compared with 88% for those receiving placebo.

“Prostate cancer patients at a high risk of relapse face a considerable risk of recurrence and metastatic spread, making early, highly effective intervention vital,” said Dr. Tamim Niazi, Associate Professor of Oncology at McGill University, Radiation Oncologist at the Jewish General Hospital in Montreal, Canada. and Co-Lead Investigator of the study. “The clear improvement in metastasis-free survival seen in interim results from the DASL-HiCaP trial highlights the potential of adding darolutamide to standard androgen deprivation therapy and radiation therapy to help prevent or delay disease progression in patients who are at high risk of progression despite receiving primary curative therapy.”

Secondary endpoints also showed consistent positive trends with darolutamide, with a 53% reduction in the risk of prostate-specific antigen progression free survival (PSA-PFS; HR 0.47; 95% CI: 0.33–0.67), and a 4-year PSA-PFS rate of 91% versus 83% with placebo. Prostate cancer-specific survival (PCSS) and overall survival (OS) hazard ratios were 0.58 (95% CI: 0.17–1.97; 99% vs 99% at 4 years) and 0.88 (95% CI: 0.49–1.59; 97% vs 95% at 4 years), respectively, with follow-up ongoing.

The safety profile of darolutamide was consistent with its known tolerability, with adverse events being similar to the placebo group. Proportions of patients experiencing Grade ≥2 adverse events of special interest for darolutamide versus placebo were: fatigue/asthenia (14% vs 10%), hypertension (7% vs 9%), fractures (2% vs 3%), and cardiac events (3% vs 3%). Any Grade ≥3 adverse event occurred in 43% of patients in the darolutamide group versus 36% in the placebo group.

"These new data highlight the potential of darolutamide to make a meaningful difference for patients earlier in the course of their prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer’s Pharmaceuticals Division. “By advancing darolutamide into earlier disease settings, we aim to reach more patients across the prostate cancer care continuum. We are proud to support ANZUP, the Sydney Clinical Trials Centre, CCTG and international partners in research as we work together with the potential to improve outcomes for men living with prostate cancer.”

Follow-up of participants is continuing to provide further information on longer-term outcomes, including overall survival.

About the DASL-HiCaP trial (ANZUP1801)
The DASL-HiCaP trial is an investigator-initiated, randomized, placebo-controlled, Phase III trial (NCT04136353) evaluating darolutamide added to standard-of-care ADT and locoregional radiation therapy in prostate cancer patients at high risk of recurrence.

DASL-HiCaP was conducted in collaboration with the University of Sydney and ANZUP Clinical Trials Group and is the fourth Phase III trial for darolutamide. Following ARAMIS, ARASENS, and ARANOTE, which demonstrated darolutamide’s efficacy and safety in advanced prostate cancer, DASL-HiCaP represents the first Phase III study of darolutamide in early prostate cancer.

A total of 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland and the United Kingdom were randomized 1:1 to receive darolutamide (600 mg twice daily) or matching placebo for 96 weeks, combined with an LHRH analog for 96 weeks and RT to the prostate/prostate bed and pelvic lymph nodes.

The primary endpoint was metastasis-free survival based on conventional imaging (MFS-CI). Secondary endpoints included prostate-specific antigen progression free survival (PSA-PFS), prostate cancer-specific survival (PCSS), and overall survival (OS). The protocol specified an interim analysis after 87 MFS-CI events; follow-up is ongoing to evaluate long-term overall survival.

About the Sydney Clinical Trials Centre
The Sydney Clinical Trials Centre is a flagship research centre of the Faculty of Medicine and Health at the University of Sydney that designs and manages clinical trials. This includes responsibility for study coordination, monitoring, data acquisition and management and statistical analysis. The Sydney Clinical Trials Centre has health economics, biostatistics, systematic reviews and biomarker teams that work with trial data and inform healthcare providers about best practice. For further details, please visit its website at https://www.ctc.usyd.edu.au

About ANZUP Clinical Trials Group
ANZUP (https://www.anzup.org.au) is the leading cancer-cooperative trials group bringing together all of the professional disciplines and groups involved in researching and treating urogenital cancers to conduct high-quality cancer research. ANZUP’s mission is to improve the lives of people affected by bladder, kidney, testicular, penile, and prostate cancers, towards our vision of living life without fear of cancer. ANZUP identifies gaps in evidence and areas of clinical need, collaborates with the best clinicians and researchers in genitourinary cancer and communicates frequently and effectively with the broader community along the way. ANZUP receives valuable infrastructure support from the Australian Government through Cancer Australia and research funding from Prostate Cancer Foundation of Australia.

About Prostate Cancer
Prostate cancer is the second most common cancer and the fourth most common cause of cancer death in men worldwide.Over 1.5 million men are diagnosed with prostate cancer each year and almost 420,000 die from the disease worldwide. By 2040, prostate cancer diagnoses are projected to increase to 2.9 million.

Standard therapy for prostate cancer patients at high risk of recurrence combines radiation therapy with androgen deprivation therapy (ADT). However, despite this approach, a significant proportion of patients experience treatment failure, local recurrence, or distant metastases. Intensifying therapy early with an advanced androgen receptor inhibitor aims to improve long-term disease control and delay metastatic progression.

About darolutamide (Nubeqa™)
Darolutamide is an oral ARi with a distinct chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans support darolutamide's low potential for blood-brain barrier penetration and low potential for clinically relevant drug-drug interactions.

Darolutamide, under the brand name Nubeqa™ plus androgen deprivation therapy (ADT), is already approved in more than 85 markets around the world, including the US, EU and China. It is approved for the treatment of adult patients with mHSPC without docetaxel in 75 markets and with docetaxel in more than 85 countries, and for adult patients with nmCRPC at high risk of developing metastatic disease in more than 85 countries.

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

Darolutamide demonstrated efficacy and tolerability in pivotal Phase 3 studies, supporting its indications in nmCRPC and mHSPC with and without chemotherapy, with a favorable safety profile that offers an advancement in treatment management for physicians and patients.

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. Current ongoing trials include the Phase III ARASTEP trial evaluating the efficacy of darolutamide plus ADT compared to ADT alone in hormone-sensitive prostate cancer (HSPC), in patients with high-risk biochemical recurrence (BCR) who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

About Prostate Cancer at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer. The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives.

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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Finerenone showed consistent effects in reduction of UPCR, UACR and kidney function decline versus placebo in diverse patient populations with chronic kidney disease without diabetes

Thu, 22 Oct 2026 17:59:57 +0200

Berlin, October 22, 2026 – Bayer today announced results from two subgroup analyses from the Phase III FIND-CKD study, showing that finerenone provides consistent kidney-protective effects in diverse etiologies of chronic kidney disease (CKD) without diabetes, including focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN).

“Patients living with FSGS and IgAN face a high risk of disease progression and kidney failure, underscoring the significant unmet need for new treatment options. Despite differences in the biological mechanisms underlying glomerular diseases, consistent, clinically meaningful reductions in proteinuria and a slower kidney function decline were observed with finerenone in both the IgAN and the FSGS subgroups. These findings further support the kidney-protective benefits of finerenone in CKD without diabetes,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “These findings provide important insights to slowing disease progression and improving long-term patient outcomes in CKD without diabetes.”

Results in patients with Focal Segmental Glomerulosclerosis (FSGS):

The FSGS subgroup in the FIND-CKD study included 215 patients, 50% of whom had primary and 50% secondary FSGS. Overall, finerenone preserved kidney function, lowered proteinuria (UPCR), and was well tolerated in the subgroup of patients with FSGS. Finerenone showed a statistically significant improvement in total estimated glomerular filtration rate (eGFR) slope (mL/min/1.73 m²/year) over 32 months compared with placebo (between-group difference: 1.3 mL/min/1.73 m²/year [95% CI, 0.5-2.2; p<0.01], with a consistent treatment effect among patients with primary or secondary FSGS. Finerenone demonstrated a numerical reduction of 42% versus placebo for the kidney composite outcome of sustained ≥57% eGFR decline or kidney failure (HR 0.58, 95% CI 0.30-1.15). From baseline to month 12, finerenone lowered urine albumin-to-creatinine ratio (UACR) by 40% (95% CI, 26–52) and urine protein creatinine ratio (UPCR) by 41% (95% CI, 26–53).

Results in patients with immunoglobulin A nephropathy (IgAN):

In FIND-CKD, 416 out of overall 1584 patients had immunoglobulin A nephropathy. The effect of finerenone on total eGFR slope (mL/min/1.73 m²/year) over 32 months versus placebo was 0.63 (95% CI, 0.19-1.46] in participants with IgAN. From baseline to Month 12, finerenone reduced UPCR vs placebo by 51% (95% CI, 42–59). Finerenone was associated with a nearly 7-fold increase in the odds of achieving a UPCR of <500mg/g at month 12 (odds ratio [OR] 6.82; 95% CI, 3.71-13.14) versus placebo. Similarly increased odds were observed for achieving UPCR <300 mg/g (OR 6.68; 95% CI 3.27-14.85). In addition, finerenone did not modify plasma or serum markers of immunological disease activity, but did reduce several kidney injury biomarkers implicated in tubulointerstitial inflammation and fibrosis, suggesting the mechanism of finerenone is likely distinct from and complementary to those of immunological therapies for IgAN.

In both subgroup analyses, finerenone was well tolerated, with a safety profile consistent with that of the overall trial population, and the incidence of hyperkalemia leading to permanent discontinuation was low.

Among the non-diabetic CKD patients included in FIND-CKD, approximately 60% had an underlying glomerular disease, around half of them had immunoglobulin A nephropathy (IgAN) or focal segmental glomerulosclerosis (FSGS). The results of the FSGS and IgAN subanalyses were presented today as late-breaking posters at the American Society of Nephrology’s (ASN) Kidney Week 2026 in Denver, Colorado.

Approximately 850 million people worldwide have CKD. An estimated 50-70% of these patients have CKD without diabetes. Additionally, more than 3.5 million people with kidney failure are treated with dialysis, which is associated with a 5-year survival rate of about 40% after treatment initiation. CKD without diabetes can have a range of etiologies, of which the most common include kidney disease linked to hypertension and glomerulonephritis (including immunoglobulin A nephropathy (IgAN) or focal segmental glomerulosclerosis (FSGS)). Despite standard of care, patients with CKD without diabetes remain at risk of kidney failure and cardiovascular events.

About Kerendia^™/ Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway that in five pivotal Phase III studies has demonstrated cardiovascular and/or kidney benefits across a broad range of patient populations, including patients with HF with left ventricular ejection fraction (LVEF) ≥40%, patients with CKD associated with type 2 diabetes, patients with CKD associated with type 1 diabetes, and patients with CKD without diabetes.Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Since 2021, finerenone has been marketed as Kerendia™ or, in selected countries, as Firialta™, and has been approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is also approved for the treatment of heart failure with left ventricular ejection fraction (LVEF) ≥ 40% in the U.S., the EU, Japan, and China among other Health Authorities, with additional applications under regulatory review. In the U.S., finerenone has recently been approved for the treatment of adult patients with CKD associated with type 1 diabetes. Applications for marketing authorization of finerenone in CKD without diabetes have been filed in China, Japan and the U.S., with further submissions underway. Finerenone is currently not approved for the treatment of CKD without diabetes.

The clinical study program with finerenone, FINEOVATE, currently comprises twelve Phase III studies with dedicated programs in CKD and HF respectively. The THUNDERBALL CKD program consists of the completed Phase III studies FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE, and the Phase II study CONFIDENCE; as well as the ongoing Phase III studies in pediatric patient populations FIONA, and FIONA-OLE. The MOONRAKER program includes the completed pivotal Phase III study FINEARTS-HF, the ongoing investigator-sponsored, collaborative studies REDEFINE-HF, CONFIRMATION-HF, and FINALITY-HF, as well as the ongoing Phase III studies in pediatric patient populations, FIORE and FIORELLO.

About FIND-CKD
FIND-CKD is the largest Phase III study to date focused on CKD without diabetes. The study investigated finerenone in a broad patient population spanning different etiologies of CKD without diabetes, adding to the positive data and breadth of evidence of finerenone in CKD. FIND-CKD investigated the efficacy and safety of finerenone compared to placebo in addition to standard of care in more than 1,500 patients with CKD without diabetes, including kidney disease linked to hypertension and glomerular diseases. Patients were randomized to receive either finerenone 10mg or 20mg or placebo on top of maximum tolerated labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

In FIND-CKD, finerenone demonstrated significant cardiorenal benefits versus placebo, in addition to standard of care. Over 32 months, patients treated with finerenone experienced a statistically significant 0.7 ml/minute/1.73 m²/year slower annual decline in eGFR than those receiving placebo. Finerenone also significantly reduced the risk of the key secondary composite cardiovascular-kidney outcome by 23% compared with placebo. Additional secondary endpoints, including composites of sustained ≥57% eGFR decline or kidney failure, and of hospitalization for heart failure or cardiovascular death, showed results consistent with the overall positive profile of finerenone.

Finerenone was well-tolerated in the FIND-CKD study, which is consistent with the well-established safety profile of finerenone.

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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

AskBio Announces 5 Presentations at the European Society of Gene and Cell Therapy (ESGCT) 33rd Annual Congress

Thu, 22 Oct 2026 14:00:00 +0200

Durham, N.C., – October 22, 2026 – AskBio Inc. (AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, and its subsidiary Viralgen Vector Core S.L.U. (Viralgen) will deliver five presentations offering insights into advancements in manufacturing technologies of adeno-associated virus (AAV) therapies for a range of diseases, at the European Society of Gene and Cell Therapy (ESGCT) 33^rd Annual Congress taking place October 27–30, 2026, in Hamburg, Germany.

“ESGCT is one of the defining scientific meetings for the global cell and gene therapy community, and at AskBio we are proud to continue contributing to the science that is shaping the future of these potentially transformative medicines,” said Gustavo Pesquin, Chief Executive Officer, AskBio. “Our presence this year highlights advances across our AAV manufacturing platform and our work to make production increasingly reproducible, measurable and robust. Collectively, these presentations reflect our continued investment in the technologies, analytical capabilities and process understanding needed to consistently and reliably manufacture gene therapies at scale with a goal to ultimately bring them to the patients who may benefit.”

AskBio’s presentations include (all times CET):

Posters

Development of a stable producer cell line for successful AAV production (Poster #P0767). Poster Session I, Wednesday, October 28, 1:30–3:30 p.m., Elena Lazarova, Scientist II, Cell Line Development, AskBio.
In-line capacitance probes enable enhanced and consistent high-quality rAAV manufacturing (Poster #P0803). Poster Session I, Wednesday, October 28, 1:30–3:30 p.m., Andoni Gonzalez, R&D Associate Scientist, Viralgen.
Optimization of recombinant adeno-associated virus vector production: Integrating synthetic molecules to enhance vector yield and quality for clinical gene therapy applications (Poster #P0801). Poster Session I, Wednesday, October 28, 1:30–3:30 p.m., Jose Luis Abad Minguez, R&D Senior Scientist, Viralgen.
Repeatability and intermediate precision of a genome integrity assay for rAAV by long-read sequencing (Poster #P0253). Poster Session I, Wednesday, October 28, 1:30–3:30 p.m., Oihana Aldasoro, R&D Associate Scientist, Viralgen.
Investigations of AAV stability under stress conditions using small-scale models (Poster #P0802). Poster Session II, Thursday, October 29, 2:00–4:00 p.m., Ferran Vila Julia, MSAT Scientist, Viralgen.

AskBio continues to develop an ambitious portfolio of investigational AAV-based gene therapies with the potential to treat some of the world’s most debilitating diseases, including congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. By targeting diseases in several therapeutic areas, AskBio aims to deliver innovative treatments that may possibly benefit more than 35 million patients worldwide.^1–5

About AskBio

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to steering gene therapy into a new era where it can transform the lives of a wider range of people living with rare and more common diseases. The company maintains a portfolio of clinical programs across a range of disease indications related to a single gene or multiple factors across cardiovascular, central nervous system, and neuromuscular conditions, with a clinical-stage pipeline that includes investigational therapeutics for heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s end-to-end gene therapy platform includes our Pro10™ technology and Aava™ manufacturing platform, which make gene therapies more accessible by making research and commercial grade manufacturing more affordable. With global headquarters in Durham, North Carolina, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing. An early innovator in the gene therapy field with over 900 employees in five countries, the company holds more than 600 patents and patent applications in areas such as AAV production and chimeric capsids. Learn more at www.askbio.com or follow us on LinkedIn.

About Viralgen

Viralgen Vector Core S.L.U. is a leading Contract Development and Manufacturing Organization (CDMO) specializing exclusively in adeno-associated virus (AAV)–based cell and gene therapies. Founded in 2017 as a subsidiary of AskBio Inc. within the Bayer AG group, Viralgen delivers end-to-end support from early development to large-scale commercial manufacturing. Leveraging their proprietary Pro10™ suspension cell line and Aava™ manufacturing platform, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes. Located in San Sebastián, Spain, its state-of-the-art facility includes three cGMP suites with 2,000-liter capacities each, certified by the AEMPS/EMA, and integrates services including plasmid production, process optimization, fill-finish, and in-house QC testing. With over 1,500 AAV batches produced, Viralgen provides reliable, efficient solutions to bringing life-changing gene therapies to patients with greater speed and consistency. Learn more at https://viralgen.com and follow us on LinkedIn.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

AskBio Forward-Looking Statements

This press release contains “forward-looking statements.” Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding AskBio’s clinical trials. These forward-looking statements involve risks and uncertainties, many of which are beyond AskBio’s control. Known risks include, among others: AskBio may not be able to execute on its business plans and goals, including meeting its expected or planned clinical and regulatory milestones and timelines, its reliance on third-parties, clinical development plans, manufacturing processes and plans, and bringing its product candidates to market, due to a variety of reasons, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved in a timely manner, potential disagreements or other issues with our third-party collaborators and partners, and regulatory, court or agency feedback or decisions, such as feedback and decisions from the United States Food and Drug Administration or the United States Patent and Trademark Office. Any of the foregoing risks could materially and adversely affect AskBio’s business and results of operations. You should not place undue reliance on the forward-looking statements contained in this press release. AskBio does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

References

1. Parkinson’s Foundation. Understanding Parkinson’s. Statistics. Available at: https://www.parkinson.org/understanding-parkinsons/statistics. Accessed: October 2026.

2. Malik A, et al. Congestive Heart Failure. In: StatPearls. Treasure Island (FL): StatPearls Publishing; Last update February 2025.

3. MedlinePlus Genetics. NIH. Limb-girdle muscular dystrophy. Available at: https://medlineplus.gov/genetics/condition/limb-girdle-muscular-dystrophy/#frequency. Accessed October 2026.

4. Goh Y, et al. Multiple system atrophy [published online ahead of print, 2023 Mar 16]. Pract Neurol. 2023; practneurol-2020-002797.

5. United Pompe Foundation. About Pompe Disease. Available at: https://www.unitedpompe.com/about-pompe-disease/. Accessed: October 2026.

Media Contact:
Phil McNamara
Vice President, Corporate Communications, AskBio
E: pmcnamara@askbio.com
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EU and UK Risk Falling Further Behind Global Agricultural Competitors, Weakening Strategic Autonomy

Thu, 15 Oct 2026 11:30:00 +0200

Leverkusen, October 15, 2026 – The EU and the UK risk falling further behind major agricultural competitors like the US, Brazil, China, Canada and India unless farmers gain faster access to innovation that can help address growing climate and productivity pressures. A more proportionate regulatory framework and more openness to new technologies could help reverse this trend. These are the main takeaways of a new report commissioned by Bayer, combining economic analysis by Oxford Economics, representative polling of more than 8,000 consumers and in-depth farmer interviews across eight European markets.

The findings identify crop agriculture as a strategically important sector that underpins food security and contributes 246 billion euros to EU GDP and 5.7 billion euros to UK GDP, with every 1 billion euros of crop agriculture output supporting almost 3 billion euros of downstream production in other sectors. However, crop output growth in Europe has significantly lagged global peers between 2011 and 2023, averaging just 0.1 percent a year. In the UK, growth was even lower, at 0.0 percent. This compares with 1 percent in the US, a global average of 2 percent, and between 2 and 3 percent in China, Canada and India. Brazil was among the fastest-growing markets, with annual growth averaging 3.3 percent over the period. The longer-term comparison is equally stark: average EU production was only 2 percent higher than in the previous decade, compared with increases of 16 percent in the US, 44 percent in Canada and 51 percent in Brazil.

These competitive pressures are being compounded by sharply rising input costs and the growing impact of climate change. Climate-related risks already cause estimated average annual losses of 17.4 billion euros—equivalent to 6.4 percent of EU crop production—with significant variation across regions. By 2050, these losses are projected to rise to between 24.8 billion euros and 28.9 billion euros.

The research identifies a growing risk arising from the rapid pace at which pressures on farmers are intensifying, combined with the time it takes for innovations to reach the field. European farmers compete against producers from other regions who have access to a wider variety of seed technologies, crop protection solutions and digital technologies or gain access to such innovations faster. According to Oxford Economics, better access to modern technologies can support farmers in addressing the significant climate and geopolitical challenges, strengthening the agricultural sector’s competitiveness and resilience.

“The EU and the UK are confronted with a widening resilience gap. To counter that, agriculture must be understood as a critical strategic sector for Europe’s autonomy and competitiveness,” said Frank Terhorst, Head of Strategy & Sustainability for Bayer’s Crop Science Division. “It is critical to embrace innovation as an opportunity rather than a risk to be managed. Europe has the capabilities to lead, but we need to ensure that enough solutions are available to farmers and that innovation can reach the field faster.”

Research highlights regulatory barriers to agricultural innovation

The report argues that European farmers need access to a broader range of solutions, including innovative seed technologies, modern crop protection products, precision agriculture, automation and artificial intelligence. Just recently, Bayer announced an upcoming phase of major innovation launches with new seed and trait solutions, including genome editing, and the AI-enabled discovery of new modes of action for crop protection. However, the availability of these agricultural solutions depends largely on regulatory frameworks.

The research findings highlight a growing concern among farmers that their toolbox is becoming increasingly constrained: While more than 1,000 active ingredients were authorised in the EU in the early 2000s, only around 420 remain approved today. Farmers have lost access to 92 active ingredients in the last seven years, while only one new synthetic active ingredient reached the market over the same period. The UK has approved four entirely new active ingredients since 2022 that remain unapproved or pending in the EU while maintaining approval of 15 crop protection active ingredients whose EU licences have expired or been banned since Brexit. However, the dynamic alignment with the EU regulatory framework currently under discussion could lead to a withdrawal of these approvals, potentially impacting crop yields and farm incomes if transitions are not managed carefully.

As a consequence, the research points to the need for a more predictable and proportionate regulatory environment that supports innovation while maintaining high standards of safety and stewardship. It highlights lengthy approval processes, increasing administrative burdens and slower adoption pathways as factors limiting access to new technologies across Europe.

“An approval approach based on real-world risks and benefits instead of theoretical hazards can help ensure farmers gain access to proven innovations while maintaining Europe's high safety standards. Recent UK approvals demonstrate how proportionate pathways can support quicker access to innovation,” added Frank Terhorst. “The report’s findings underscore the urgent need for agricultural innovation. We invest heavily in such new solutions, and we want European farmers to benefit from them like their global peers do.”

Consumers recognise the importance of agriculture and support science-based innovation

The consumer polling reveals public awareness of the strategic importance of agriculture. Across Europe, 84 percent of consumers agree that food security is a matter of national security. Consumers see farmer resilience, food affordability and food security as interconnected elements of the same challenge.

Europeans are also broadly supportive of science and technology. 84 percent say farmers should have access to the latest technology and innovation, so that innovation moves faster, farmers get better harvests and food prices come down. They perceive regulatory barriers, too: 77 percent say cutting bureaucracy and red tape would help make sure Europe can produce enough food. 63 percent say they are more likely to vote for a party that backed farmers using new science and technology.

“Europeans are more open to innovation and technology than many would assume. People see the connection between resilient farming, food security and affordable food,” summarised Matthias Berninger, Head of Public Affairs, Science, Sustainability & HSE at Bayer. “The findings are a call to action for political, business and civil-society leaders to champion science and new technologies. Europe has spent too much time admiring problems rather than seizing opportunities. While regulation must ensure safety and build trust, it should also enable progress in areas such as AI and agriculture. Europe must move from a culture of risk avoidance to one of innovation.” According to Berninger, Europe has exactly what it takes: “This summer’s decision on New Genomic Techniques demonstrated that Europe can choose innovation over hesitation. We must not lose that momentum. We have great farmers, scientific expertise, good soils and industrial capabilities. We now need to translate these strengths into greater resilience and competitiveness.”

About the report:
The research was commissioned by Bayer and combines economic analysis conducted by Oxford Economics, representative polling of more than 8,000 consumers and in-depth interviews with around 90 farmers across eight European markets (Benelux, France, Germany, Italy, Poland, Romania, Spain, United Kingdom). It examines the role innovation can play in strengthening the productivity, competitiveness and resilience of European agriculture, as well as the conditions affecting access to and adoption of new technologies.

Materials are available for download here:

Overall summary
Economic study by Oxford Economics
Insights from the farmer interviews
Insights from the consumer survey

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Vividion Therapeutics Expands Clinical Development of WRN Inhibitor VVD-214 with Phase II Combination Study in First-Line Patients with Advanced Colorectal Cancer

Thu, 15 Oct 2026 08:30:02 +0200

San Diego, CA, USA, and Berlin, Germany, October 15, 2026 – Vividion Therapeutics, Inc. (Vividion), a clinical-stage biopharmaceutical company and a wholly owned and independently operated subsidiary of Bayer AG, today announced that the first patient has been dosed in a Phase II clinical trial of VVD-214, an investigational oral inhibitor of Werner helicase (WRN). The randomized study will evaluate VVD-214 in combination with pembrolizumab versus pembrolizumab alone as first-line treatment for patients with advanced microsatellite instability-high (MSI-high) or deficient mismatch repair (dMMR) colorectal cancer. Colorectal cancer remains an area of significant medical need, and approximately 15 percent of tumors are MSI-high, representing the largest population of patients with MSI-high disease.

The Phase II trial expands clinical development of VVD-214 to investigate its potential applicability in earlier treatment lines for advanced colorectal cancer. Vividion’s recently initiated Phase Ib clinical trial (NCT06004245) is additionally evaluating VVD-214 in combination with bevacizumab in patients with MSI-high or dMMR colorectal cancer whose disease has progressed following prior lines of therapy.

“The progress of VVD-214 has strengthened our conviction in WRN inhibition and created an opportunity to broaden the program in front-line colorectal cancer, where effective and better tolerated treatment options are needed,” said Aleksandra Rizo, M.D., Ph.D., President and Chief Executive Officer of Vividion. “Supported by encouraging early clinical data and strong investigator interest, we are moving rapidly into Phase II to evaluate VVD-214 in the first-line setting and explore its potential to improve outcomes for more patients.”

VVD-214 is an investigational oral small-molecule inhibitor of WRN, a DNA repair enzyme and synthetic lethal target for MSI-high or dMMR cancers. By inhibiting WRN, VVD-214 is designed to selectively induce lethal DNA damage in cancer cells while minimizing harm to normal cells. Preliminary data from the Phase Ia study presented at the American Association for Cancer Research (AACR) 2025 Annual Meeting and published in Nature Medicine showed that VVD-214 was well tolerated with early signals of activity.²

“The encouraging clinical evidence generated to date gives us confidence to broaden the program into the first-line setting and evaluate VVD-214 as a meaningful new treatment option for patients with MSI-high or dMMR colorectal cancer,” said Christian Rommel, Ph.D., Global Head of Research and Development at Bayer’s Pharmaceuticals Division.

The global Phase II trial of VVD-214 (NCT07811193) is planned to enroll approximately 140 patients at clinical sites across approximately 21 countries in North America, Latin America, Europe and Asia. The primary endpoint is six-month progression-free survival rate, with secondary endpoints including objective response rate, disease control rate, duration of response, overall survival and safety.

Vividion also has ongoing Phase I trials evaluating an oral KEAP1 activator in advanced solid tumors and a RAS-PI3Kα inhibitor designed to target RAS-driven cancers. The company is advancing multiple innovative drug discovery programs toward the clinic, with a growing early discovery pipeline, emerging from its chemoproteomics platform, that spans oncology and immunology.

References:

¹Vilar E, Gruber SB. Microsatellite instability in colorectal cancer-the stable evidence. Nat Rev Clin Oncol. 2010;7(3):153-62.

² Yap TA, Fontana E, Cook N, et al. Werner helicase inhibitor for advanced microsatellite instability solid tumors: a phase 1 trial. Nat Med. Published online September 29, 2026. doi:10.1038/s41591-026-04657-3.

About Vividion
Vividion Therapeutics, Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a clinical-stage biopharmaceutical company utilizing novel discovery technologies to unlock difficult-to-drug targets with strong disease-links, and to develop small molecule precision therapeutics for devastating cancers and immune disorders. The company’s platform has enabled it to identify hundreds of previously unknown functional pockets on well-validated protein targets implicated in a wide range of diseases, while simultaneously identifying compounds from its proprietary covalent chemistry library that interact in a highly selective manner with those pockets. The company is leveraging its proprietary chemoproteomic platform to advance a diversified pipeline of highly selective small molecule therapeutics targeting high-value, traditionally undruggable targets in oncology and immunology. For more information, please visit www.vividion.com.

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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Vividion Media Contact:
Rhiannon Benilov, phone +1 978 417 1946
Email: rhiannon@tenbridgecommunications.com

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Julia Schulze, phone +49 175 586 6432
Email: julia.schulze@bayer.com

Bayer Foundation honors five outstanding scientists with the Science Awards 2026

Wed, 14 Oct 2026 11:11:47 +0200

Leverkusen, October 14, 2026 – In 2026, Bayer Foundation honors five outstanding scientists whose research opens up new perspectives and areas for action in health, agriculture and biomedical innovation. The prestigious Otto Bayer Award goes to Sarah O’Connor. The Early Excellence in Science Awards are presented to Colinda Scheele (Biology), James Eills (Chemistry), Antonia Morita Saktiawati (Medical Science) and Bruno Pok Man Ngou (Plant Science).

Otto Bayer Award 2026: Sarah O’Connor

Bayer Foundation presents the 2026 Otto Bayer Award to Sarah O’Connor, Director at the Max Planck Institute for Chemical Ecology in Jena. She is recognized for her pioneering research into the biosynthesis of natural plant compounds. Her work deciphers how plants produce complex molecules that can be used, among other applications, as medicines against cancer and other diseases.

Through her research, O’Connor has uncovered numerous previously unknown biochemical processes that lead to the formation of valuable natural products, including medically important alkaloids such as vinblastine, quinine and ibogaine. These compounds are used, for example, in the treatment of cancer (vinblastine) or malaria (quinine), or are in clinical trials for treatment of mental health and substance use disorders (ibogaine). Her work lays the foundation for producing important active ingredients more sustainably and efficiently in the future, while opening up new opportunities for drug discovery and development.

The Otto Bayer Award is one of Bayer Foundation’s most prestigious science awards and among the most highly endowed research prizes in Germany. Presented every two years in alternation with the Hansen Family Award, it recognizes leading scientists working in German-speaking countries for groundbreaking research contributions in chemistry or biochemistry. The award, endowed with EUR 75,000, was established in 1984 through a generous provision in the will of Otto Bayer, a former Director of Research at Bayer AG.

With the Early Excellence in Science Awards, the Foundation has recognized emerging talents for remarkable research contributions in the natural sciences since 2009. To date, 51 talents have received the awards. Each Early Excellence in Science Award includes prize money of EUR 10,000 for the researcher.

Early Excellence in Science Award in Biology: Colinda Scheele

The Early Excellence in Science Award in Biology goes to Colinda Scheele from the VIB–KU Leuven in Belgium. She investigates how cancer develops and why some altered cells form tumors while others are stopped by the surrounding tissue.

Her research has shown that even breast tissue that appears healthy from the outside can already contain genetic changes that precede cancer. At the same time, she has identified protective mechanisms in the tissue that prevent tumor formation. These insights open up new possibilities for detecting breast cancer earlier, improving prevention and further advancing therapies.

Early Excellence in Science Award in Chemistry: James Eills

The Early Excellence in Science Award in Chemistry is presented to James Eills from Forschungszentrum Jülich. His research improves methods in magnetic resonance spectroscopy and imaging that are used to visualize biological processes.

Together with his research team, he develops new hyperpolarization methods that significantly increase the sensitivity of these measurement techniques. In the future, this could make it possible to visualize metabolic processes in the body faster, more cost-effectively and without radioactive markers. This opens promising perspectives for cancer diagnostics and other medical applications.

Early Excellence in Science Award in Medical Science: Antonia Morita Saktiawati

In the Medical Science category, Antonia Morita Saktiawati from the Center for Tropical Medicine at Universitas Gadjah Mada in Indonesia is recognized. She develops AI-supported diagnostic tools that can detect infectious diseases such as tuberculosis at an early stage and can be deployed in remote areas, making diagnosis possible even in regions with limited medical infrastructure.

Her research developments include an AI-based system for interpreting chest X-rays (TBScreen.AI) as well as an artificial nose system, also known as an electronic nose or e-Nose, that can detect diseases based on breath samples. Her research helps make life-saving diagnostics faster, more affordable and accessible to significantly more people.

Early Excellence in Science Award in Plant Science: Bruno Pok Man Ngou

The award in Plant Science is new and will be presented for the first time in 2026 to Bruno Pok Man Ngou from the RIKEN Center for Sustainable Resource Science (CSRS) in Japan. His research explores how plants recognize pathogens and defend themselves against them.

Pok Man Ngou has uncovered fundamental mechanisms of the plant immune system and identified new classes of immune receptors. Building on these insights, he is developing new approaches to equip plants with enhanced defense mechanisms. His findings could help to breed crops that are more resistant to disease and to improve harvest yields in the future.

Science with societal impact

With its Science Awards, Bayer Foundation recognizes outstanding research that pushes scientific boundaries while holding the potential to address concrete societal challenges in health, agriculture and the environment. This year’s awardees exemplify a new generation of scientists whose insights are helping advance health, food security and sustainable innovation.

About Bayer Foundation
Bayer Foundation is the corporate foundation of Bayer, dedicated to advancing Science and Social Innovation for a world with Health for All and Hunger for None. Guided by the claim “Innovation that matters,” the Foundation supports transformative innovations in health and agriculture to address systemic challenges, particularly in low- and middle-income countries.

Since 2007, Bayer Foundation’s science programs have reached more than 1,000 early-career scientists with fellowships across 40 countries. Bayer Foundation’s prestigious awards have recognized more than 80 outstanding scientists, of whom five later became Nobel Laureates. In Germany, Bayer Foundation is also driving the support of STEM education and has funded more than 700 STEM school projects with more than EUR 6 million.

For more information, please visit the Bayer Foundation website.
Find more information at www.bayer.com.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

U.S. FDA accepts Bayer’s supplemental New Drug Application for finerenone in chronic kidney disease without diabetes

Thu, 08 Oct 2026 08:30:02 +0200

Berlin, October 8, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for finerenone (Kerendia™), supporting a potential new indication in adults with chronic kidney disease (CKD) without diabetes. The application is based on results from the pivotal Phase III FIND-CKD study, which showed that finerenone significantly delayed kidney disease progression and reduced cardiovascular-kidney events versus placebo, in addition to standard of care, in a broad population of adults with CKD without diabetes.

“For many people living with CKD without diabetes, kidney function can decline silently for years before symptoms become apparent, while the risk of kidney failure and cardiovascular complications continues to rise,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “The FDA’s acceptance of our application marks an important step toward potentially expanding the use of finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA), to a broader group of patients who still have few treatment options and may benefit from the cardio-kidney protective effects of finerenone. By targeting mineralocorticoid receptor overactivation, finerenone addresses a pathway implicated in kidney disease progression and cardiovascular damage.”

Approximately 850 million people worldwide, and more than 35 million adults in the U.S. have CKD. An estimated 50-70% of these patients have CKD without diabetes. Additionally, more than 3.5 million people with kidney failure are treated with dialysis, which is associated with a 5-year survival rate of about 40% after treatment initiation. CKD without diabetes can have a range of etiologies, of which the most common include kidney disease linked to hypertension and glomerulonephritis (including immunoglobulin A nephropathy (IgAN) or focal segmental glomerularsclerosis (FSGS)). Despite standard of care, patients with CKD without diabetes remain at risk of kidney failure and cardiovascular events. CKD linked to hypertension is the second most common cause of kidney failure. Patients with advanced CKD without diabetes also face a markedly higher risk of fatal cardiovascular events, about 2.6 times that of the general population without CKD, which increases further as kidney function declines.

In FIND-CKD, finerenone significantly delayed kidney disease progression and reduced cardiovascular-kidney events versus placebo, in addition to standard of care. Over 32 months, patients treated with finerenone experienced a statistically significant 0.7 ml/minute/1.73 m²/year slower annual decline in eGFR than those receiving placebo. Finerenone also significantly reduced the risk of the key secondary composite cardiovascular-kidney outcome by 23% compared with placebo. Additional secondary endpoints, including composites of sustained ≥57% eGFR decline or kidney failure, and of hospitalization for heart failure or cardiovascular death, showed results consistent with the overall positive profile of finerenone.

Finerenone was well-tolerated in the FIND-CKD study, which is consistent with the well-established safety profile of finerenone.

Find more information at www.bayer.com/en/portfolio/pharmaceuticals
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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Bayer to invest 2.2 billion U.S. dollars in a new manufacturing site in the United States

Fri, 02 Oct 2026 21:10:03 +0200

New Albany, Ohio, U.S., October 2, 2026 – Bayer announced on Friday plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio, U.S. Building on more than seven billion dollars in U.S. pharma R&D and manufacturing spend over the past five years, the project is a central element of Bayer’s long-term growth strategy and commitment to innovation and patient access in its largest pharmaceuticals market.

“Bayer has long seen the United States as a key manufacturing base and innovation hub. This landmark investment underscores our commitment,” said Bayer CEO Bill Anderson. “The new site will be home to manufacturing expertise and a skilled workforce that will strengthen our ability to deliver innovative, high-quality medicines to patients both in the United States and abroad.”

“The United States is a key market for Bayer’s Pharmaceuticals division. This expansion is another important step to grow our pharmaceuticals business and to meet the demand of our customers and patients in the U.S., our fastest-growing pharmaceuticals market, and beyond,” said Sebastian Guth, Global Chief Operating Officer, Bayer Pharmaceuticals and President, Bayer U.S.

Planned site to create highly-skilled jobs and support Ohio’s economic development

Bayer is expected to create around 600 high-value jobs in the New Albany International Business Park and roughly 1,500 construction jobs during the facility’s construction.

The flexible, modular campus is designed to combine drug substance and drug product manufacturing, leverage advanced digital and automation technologies, and support our growing portfolio initially in oncology, cardiovascular and renal care. The first module, dedicated to drug substance manufacturing, is expected to become operational in 2031.
A second module for drug product manufacturing is planned to follow in 2034. The new site will complement Bayer’s U.S. pharmaceuticals headquarters in Whippany, New Jersey and its other sites in Pittsburgh, Pennsylvania; Berkeley, California; Cambridge, Massachusetts; Research Triangle Park, North Carolina; and San Diego, California.

“The facility will be a strong strategic addition to our global Product Supply network. As we continue to invest in our existing manufacturing sites around the globe, our planned presence in Ohio will further enhance our ability to serve our markets with greater resilience and reliability,” said Holger Weintritt, Head of Product Supply at Bayer’s Pharmaceuticals division.

The site will also form part of a new U.S. based collaboration ecosystem. The ambition is to connect cutting-edge academic innovation with advanced manufacturing expertise to create a strong ecosystem that supports future-ready pharmaceutical production.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact for media inquiries:
Sue Ann Pentecost, phone +1 910 221 6446
Email: sueann.pentecost@bayer.com

Tino Andresen, +49 214 30-66048
Email: tino.andresen@bayer.com

Heidi Sylvester, phone +49 173 106-9282
Email: heidi.sylvester@bayer.com

Contact for investor inquiries:
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Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Bayer appoints Dr. Christoph Koenen, MD, as Chief Medical Officer

Thu, 01 Oct 2026 08:29:47 +0200

Berlin, October 1, 2026 – Bayer today announced the appointment of Dr. Christoph Koenen, MD, as Chief Medical Officer, effective October 1, 2026. He will lead medical and scientific strategies across the organization and assume these responsibilities in addition to his current role as Head of Clinical Development and Operations of the Pharmaceuticals Division.

“The Chief Medical Officer role reinforces Bayer’s commitment to keeping patient needs and patient safety at the center of medical and scientific decision-making throughout the product lifecycle,” said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of the company’s Pharmaceuticals Division. “Christoph Koenen brings deep experience as a physician, former Chief Medical Officer, and global R&D leader. His leadership will help further integrate clinical development and medical activities as we advance our strategic focus in R&D on delivering transformative medicines to patients faster.”

A physician and business leader with more than 25 years of global pharmaceutical experience, Christoph Koenen has held senior leadership roles at Bayer, Bristol Myers Squibb, Novo Nordisk, Boehringer Ingelheim, and GSK. Before joining Bayer in 2022, he served as Chief Medical Officer at Otsuka Pharmaceutical, where he oversaw global development, regulatory affairs, medical affairs, pharmacovigilance, quality, technical operations, value and access, and portfolio strategy.

Christoph Koenen is committed to advancing innovation in clinical development, improving patient access to new therapies, and fostering collaboration across the healthcare ecosystem. He currently serves on the Board of Directors of TransCelerate BioPharma, supporting industry-wide innovation and the modernization of clinical research. Christoph Koenen holds an MD from Ruprecht Karls University School of Medicine (Heidelberg), an MBA from Schiller International University (Florida/Heidelberg), and is board-certified in Internal Medicine and Diabetology.

Bayer focuses on therapeutic areas where the medical need is greatest, including oncology, cardiovascular and renal diseases, neurology and rare diseases, and immunology. The company is currently advancing around 30 projects in clinical development.

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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

BlueRock Therapeutics’ investigational cell therapy lemiretprocel (OpCT-001) for primary photoreceptor diseases granted orphan drug designations by FDA and EMA

Wed, 30 Sep 2026 08:30:02 +0200

Berlin, Germany, and Cambridge, MA, USA, September 30, 2026 – Bayer AG and its wholly owned, independently operated subsidiary BlueRock Therapeutics LP, a clinical stage cell therapy company, today announced that its investigational cell therapy, lemiretprocel (OpCT-001), has received orphan drug designations from the U.S. FDA and the EU EMA. U.S. FDA designations are for treating retinitis pigmentosa and cone-rod dystrophy. EU EMA designations are for treating both syndromic and non-syndromic inherited retinal disorders (IRDs) of the rod-dominant phenotype and non-syndromic IRDs of the cone-dominant phenotype.

Lemiretprocel (OpCT-001) is an investigational induced pluripotent stem cell (iPSC)-derived cell therapy being tested in a Phase 1/2a clinical study (CLARICO) for the treatment of primary photoreceptor diseases, which are a subgroup of inherited retinal disorders that include retinitis pigmentosa, Usher syndrome, and cone-rod dystrophy.¹ Lemiretprocel (OpCT-001) aims to restore vision in people living with primary photoreceptor diseases by replacing lost cells in the retina with new functional cells.

“Receiving these designations from the U.S. FDA and the EU EMA is a notable step forward for lemiretprocel,” said Amit Rakhit, MD, MBA, BlueRock’s Chief Medical Officer. “We believe that lemiretprocel has great promise as a potential therapeutic option for restoring vision in people living with primary photoreceptor diseases and look forward to continuing to work with health authorities on its clinical development.”

“Together with BlueRock, we are progressing the first-ever clinical trial for an iPSC-derived cell therapy in primary photoreceptor diseases,” said Christian Rommel, Executive Vice President and Global Head of Research and Development of the Pharmaceuticals Division at Bayer. “Receiving orphan drug designations from both the FDA and EMA recognizes lemiretprocel’s potential to address a wide range of inherited retinal disorders for patients that currently have very limited treatment options.”

Lemiretprocel (OpCT-001) is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. Lemiretprocel is the International Nonproprietary Name for OpCT-001 as acknowledged by the World Health Organization.²

¹https://www.ncbi.nlm.nih.gov/books/NBK519518; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1808442;

https://www.nidcd.nih.gov/health/usher-syndrome#b

²https://cdn.who.int/media/docs/default-source/international-nonproprietary-names-(inn)/pl134.pdf?sfvrsn=87a89aba_3&download=true

About the CLARICO study
CLARICO is a Phase 1/2a first-in-human, multisite, 2-part interventional study to evaluate the safety, tolerability, and the effect on clinical outcomes of OpCT-001 in up to approximately 54 adults with primary photoreceptor disease. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups. Phase 1 will include 4 planned dose levels to be administered across 4 cohorts (Cohorts 1 through 4). Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (~3 to 6 per cohort) will receive escalating doses of OpCT-001 after acceptable safety signals with the prior lower dose. Phase 2 is planned to enroll a maximum of 30 participants across 2 cohorts (Cohorts 5 and 6) to evaluate 2 dose levels of OpCT-001 that will be selected based on Phase 1 safety and tolerability data. Phase 2 participants will be randomized 1:1 to either Cohort 5 or Cohort 6. Phase 2 participants and the investigator/study site personnel outside of the surgical team will be masked to OpCT-001 dose assignments. Further details of the trial can be found at www.clinicaltrials.gov (NCT06789445).

About BlueRock Therapeutics LP
BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the U.S. FDA (Food and Drug Administration) and is being tested in a Phase 3 clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a Phase 1/2a clinical trial, CLARICO. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements BlueRock Therapeutics
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “plan,” and “intend,” among others. These forward-looking statements are based on BlueRock’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs, the potential benefits, timing and future operation of the agreements with FUJIFILM Cellular Dynamics and Opsis Therapeutics, the ability to advance therapies into, and successfully initiate, enrol and complete clinical trials, the potential clinical utility of product candidates, the regulatory pathway of, and the timing or likelihood of any regulatory filings and approvals for, any product candidates, and the ability to, and extent of, potentially commercializing any product candidate, are forward looking. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of BlueRock’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Bayer Global Media Contact:
Kathryne Delves-Broughton, phone +33 6 02180163
Email: kathryne.delvesbroughton@bayer.com

BlueRock Media Contact:
Jeff Lockwood, phone +1 (617) 5106997
Email: jlockwood@bluerocktx.com

Bayer Launches New Menopause Advocacy and Policy Alliance

Tue, 29 Sep 2026 15:29:50 +0200

Berlin and Rio De Janeiro, September 29, 2026 – Bayer today announced the launch of the Menopause Advocacy and Policy (MAP) Alliance, bringing together global leaders in women’s health advocacy, clinical research, academia, health policy, and industry to advance practical reform in menopause care, policy and workplace support. The MAP Alliance is funded and facilitated by Bayer.

With several of its initiatives launching at the International Menopause Society (IMS) World Congress 2026 in Rio de Janeiro, the MAP Alliance was created in response to growing recognition that menopause can have far-reaching personal, societal and economic impacts. As a global leader in women’s healthcare, Bayer has a long-standing commitment to advancing innovation and supporting progress in areas of unmet need for women worldwide, including menopause.

Despite effects of menopause on millions of women worldwide, progress remains fragmented and inconsistent across countries and sectors, underscoring the need for a coordinated, multisector response.¹

“Menopause is a universal life transition that affects women around the world, yet healthcare systems, workplaces and public policy remain poorly equipped to meet women’s needs,” said Dr Jane M. Barratt, Global Advisor on Ageing, Health and Social Policy, founding member and Chair of the MAP Alliance. “The MAP Alliance has a bold ambition: to create a world in which every woman can navigate menopause with confidence and the support she needs. This is our moment to move from awareness to action and build systems that support women’s health, wellbeing and full participation in society.”

Building the Evidence Base for Change in Menopause Management

At IMS, the MAP Alliance will present new findings from a systematic literature review examining the impact of menopause on women, healthcare systems and society. The analysis aims to expose where the evidence remains weakest, particularly around health systems and societal impacts, providing a clear foundation for high-priority future research, investment and policy development.² The findings will be available through e-poster abstract E.379, The Impact of Menopause on Individuals and Society: A Systematic Review.

“The evidence is clear: menopause can have a profound impact on women's health, wellbeing and participation in the workforce, yet too many women continue to encounter barriers to evidence-based care and support,” said Dr. Pauline Maki, Professor of Psychiatry, Psychology and Obstetrics and Gynaecology, Director of the UIC Center for Health Awareness and Research on Menopause (CHARM) and Executive Committee member of the MAP Alliance. “By connecting research, expertise and practical policy-focused solutions, the MAP Alliance aims to help close these gaps and accelerate meaningful progress.”

The review forms part of a connected approach to develop the evidence, policy insight and measurement needed to support reform. A new series of issue briefs, beginning with The State of Menopause Care Policy: A 12-country assessment of recent advances and gaps in policymaking, will examine emerging policy approaches and identify practical opportunities for change. The review features a heat map tracking progress across the five menopause policy areas that have received the greatest attention from policymakers over the past five years. It also spotlights 14 regional laws enacted across Europe, North America and South America that are advancing menopause care. Together, these insights underscore the cost of policy inaction for women, health systems, employers and national economies.³ The full report is available on the MAP Alliance website.

This work is also intended to support a consistent framework for comparing menopause care and policy across countries, helping to show where progress is being made and where further action is needed.

MAP Alliance at IMS 2026

At IMS, attendees can learn more about the MAP Alliance and its research through:

E-poster: The Impact of Menopause on Individuals and Society: A Systematic Review

o Poster E.379; digital display

Plenary panel: Menopause and the Women's Health Gap: A Blueprint for Advancing Menopause Care Globally - The Global Costs of Menopause

o October 2, 2026, 10:20-11:10 BRT, OCEANIA 9

Meet the Experts session: From Momentum to Action: Introducing the MAP Alliance

o October 2, 2026, 14:00-14:30 BRT, Booth #10-12

The MAP Alliance is calling on policymakers, healthcare leaders and employers to work together to prioritize menopause as a public health and economic issue, by increasing women’s awareness of and access to reliable menopause information, expanding access to appropriate care, improving healthcare provider education and creating supportive workplace environments that enable women to remain healthy, productive and fully engaged throughout midlife. Visit https://www.map-alliance.org and follow the MAP Alliance on LinkedIn to learn how you can get involved.

About the Menopause Advocacy and Policy (MAP) Alliance
The Menopause Advocacy & Policy (MAP) Alliance is a global alliance of cross-sector stakeholders synthesizing evidence and insights into local action that will lead to measurable change in menopause. Its mission is to enable change in systems for the well-being of women experiencing menopause, in order to create a new world in which all women can confidently navigate this major life transition. To achieve this, the MAP Alliance aims to advance effective policies and systems that promote impactful, timely and quality menopause care, and transform workplaces to support women in menopause. The MAP Alliance is funded and facilitated by Bayer.

About Menopause
By 2030, nearly 500 million women will be in the menopausal transition years.⁴The menopausal transition is a phase in women’s lives related to the cessation of menstrual cycles usually occurring in their late 40s or early 50s. Menopause symptoms can also be a consequence of surgical or medical treatment such as breast cancer treatment. The most frequently reported and disruptive menopause symptoms are VMS and sleep disturbances, which can substantially affect a woman’s health, quality of life and work productivity.^5-8 Addressing disruptive menopause symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective.

Find more information at www.bayer.com/en/portfolio/pharmaceuticals
Follow us on Facebook: http://www.facebook.com/bayer

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

References

1. Kalbarczyk A, Baker LH, Na Y, Syed M, Banegas Lagos M, Morgan R. Navigating menopausal care: a scoping review of health system responsiveness and gaps. Lancet Obstet Gynaecol Womens Health. 2026;2(6):e550-e559.

2. Menopause Advocacy and Policy (MAP) Alliance. The impact of menopause on individuals and society: a systematic review. IMS World Congress 2026. Abstract E.379.

3. Menopause Advocacy and Policy (MAP) Alliance. The state of menopause care policy: a review. 2026. Available from: MAP Alliance.

4. Wilson M, Schmidt I, Alam M, et al. The Health and Economic Impacts of Menopause: Policies and Investments to Advance Care, Opportunity, and Equity. FP Analytics; May 2025. Available in: https://impactsofmenopause.com/

5. Santoro N, Epperson CN, Mathews SB. Menopausal symptoms and their management. Endocrinol Metab Clin North Am. 2015;44(3):497-515.

6. Thurston RC, Joffe H. Vasomotor symptoms and menopause: findings from the Study of Women's Health Across the Nation. Obstet Gynecol Clin North Am. 2011;38(3):489-501.

7. Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, et al. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023;30(3):239-246.

8. Nappi RE, Kroll R, Siddiqui E, Stoykova B, Rea C, Gemmen E, et al. Global cross-sectional survey of women with vasomotor symptoms associated with menopause: prevalence and quality of life burden. Menopause. 2021;28(8):875-882.

Contact for media inquiries:
Andrew Fenwick
Email: afenwick@realchemistry.com

Bayer’s Lynkuet™ (elinzanetant) granted priority review by U.S. FDA for additional indication

Mon, 28 Sep 2026 14:30:14 +0200

Berlin, September 28, 2026 – Bayer today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental new drug application (sNDA) and granted Priority Review designation for Lynkuet™ (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women receiving endocrine therapy for the treatment or prevention of hormone receptor positive (HR+) breast cancer.

Elinzanetant was first approved in the U.S. in October 2025 for the treatment of moderate to severe VMS due to menopause, supported by data from three Phase III clinical trials (OASIS-1, OASIS-2 and OASIS-3). Being the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist), the compound is globally developed for the treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy (AET) for breast cancer, administered orally once daily.

Lynkuet also became the first therapy indicated for the treatment of moderate to severe VMS caused by AET for breast cancer in the UK, Switzerland and Canada, in addition to the initial indication of treatment of VMS associated with menopause.

In the EU, the compound had been approved in November 2025 for the treatment of moderate to severe VMS associated with menopause or caused by AET related to breast cancer.

“Endocrine therapy is a standard of care for many women facing HR+ breast cancer, which can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, Head of Clinical Trials, Scientific Affairs and International Development in Breast Oncology, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France. “It’s important that we continue to learn more about vasomotor symptoms due to endocrine therapy as part of supporting women throughout their breast cancer care journey.”

The sNDA for Lynkuet in the U.S., the indication extensions in Canada, Switzerland and the UK and the respective approval in the EU are based on results of the Phase III OASIS-4 trial. Key details and findings from the study¹:

The OASIS-4 study was a 52-week, double-blind, randomized placebo-controlled Phase III interventional study conducted at 90 sites outside of the US. A total of 474 women 18 to 70 years of age with moderate to severe VMS caused by AET for HR+ breast cancer or its prevention were randomized 2:1 to elinzanetant (n=316) for 52 weeks or placebo for 12 weeks, followed by elinzanetant for 40 weeks (n=158).
Lynkuet successfully met the primary endpoints demonstrating statistically significant reductions in the frequency of moderate to severe VMS from baseline to week 4 and 12 compared to placebo, in women receiving endocrine therapy for treatment or prevention of HR+ breast cancer.
The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1, as well as improvements of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo and maintaining the effects over the study period.
The key findings were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine (NEJM) in June 2025.

“At Bayer, we believe women deserve treatment choices that reflect the complexity of their health needs and experiences. The positive results from the OASIS-4 study further support the potential of elinzanetant to address unmet needs in menopause care, including for women facing vasomotor symptoms associated with breast cancer treatment. This confirms the potential of elinzanetant in broadening treatment options for women across different life stages and health circumstances,” said Cecilia Caetano, M.D., Vice President, Global Medical Affairs and Evidence Generation Lead Women’s Health, Bayer Pharmaceuticals Division.

Breast cancer remains the most commonly diagnosed cancer among women globally. In 2022, approximately 2.3 million women were diagnosed with breast cancer, accounting for 30% of all cancers in women. Nearly 70% of these cases are hormone receptor-positive (HR+).² AET is an established standard of care for treating HR+ breast cancer, with duration of use varying between 5 and 10 years based on cancer type and other clinical considerations.³ Treatment with AET for up to 10 years has been shown to substantially reduce breast cancer mortality rate over the two decades after diagnosis.⁴ Hot flashes are a common side effect of AET treatment, and due to the HR+ diagnosis – many women are discouraged from using hormone-releasing medicines.⁵

Earlier this year, the National Comprehensive Cancer Network updated its survivorship guidelines listing Lynkuet as a preferred non-hormonal pharmacologic treatment in the selective NK-1 and/or NK-3 receptor antagonists category for treatment of moderate to severe VMS due to medically and surgically induced menopause.⁶

Elinzanetant is approved under the brand name Lynkuet™ in several countries around the world, including Australia and the U.S., for the treatment of VMS associated with menopause and in the EU, UK, Switzerland and Canada for the treatment of moderate to severe VMS associated with menopause or caused by AET related to breast cancer. Submissions for marketing authorizations for elinzanetant are also ongoing in further countries around the world.

About elinzanetant
Elinzanetant is the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist), globally developed for the treatment of moderate to severe vasomotor symptoms (VMS; also known as hot flashes) associated with menopause or caused by endocrine therapy (ET) for breast cancer, administered orally once daily. Increasing evidence indicates that hypothalamic neurons, expressing both NK-1 and NK-3 receptors and their ligands, called kisspeptin, neurokinin B, and dynorphin (KNDy) neurons play a role in thermoregulation. Declining estrogenic activity due to natural menopause or ET leads to hyperactivity of KNDy neurons and dysregulation of the thermoregulatory center, resulting in VMS. NK-1 receptors may also have a role in the cooling response through sweating and peripheral vasodilatation as well as on sleep disturbances.

About Menopause
By 2030, nearly 500 million women will be in the menopausal transition years.⁷
The Menopausal transition is a phase in women’s lives, related to the cessation of menstrual cycles occurring in their late 40s or early 50s. Menopause symptoms can also be a consequence of surgical or medical treatment such as breast cancer treatment. The most frequently reported and disruptive menopause symptoms are VMS and sleep disturbances, which can substantially affect a woman’s health, quality of life and work productivity.^7-9 Addressing disruptive menopause symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective.

About Women’s Healthcare at Bayer
Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare, Bayer has a longstanding commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broaden treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low and middle-income countries by 2030 with access to family planning by funding multistakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

References

1. Cardoso, F, Parke S, Brennan DJ, et. al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med 2025;393:753-763.

2. Huang H, Wei T, Zhang A, et al. Trends in the incidence and survival of women with hormone receptor-positive breast cancer from 1990 to 2019: a large population-based analysis. Sci Rep. 2024;14(1):23690. Published 2024 Oct 10. doi:10.1038/s41598-024-74746

3. Burstein HJ, Temin S, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: american society of clinical oncology clinical practice guideline focused update. J Clin Oncol. 2014;32(21):2255-2269. doi:10.1200/JCO.2013.54.2258

4. Davies C, Pan H, Godwin J, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013;381(9869):805-816. doi:10.1016/S0140-6736(12)61963-1

5. American Cancer Society. (2025, October 27). Menopausal hormone therapy after breast cancer. https://www.cancer.org/cancer/types/breast-cancer/living-as-a-breast-cancer-survivor/menopausal-hormone-therapy-after-breast-cancer.html

6. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Survivorship (Version 3.2025). https://www.nccn.org/professionals/physician_gls/pdf/survivorship.pdf Published February 2, 2026. Accessed April 7, 2026.

7. Wilson M, Schmidt I, Alam M, et al. The Health and Economic Impacts of Menopause: Policies and Investments to Advance Care, Opportunity, and Equity. FP Analytics; May 2025. Available in: https://impactsofmenopause.com/

Bayer places 2 billion euro hybrid bonds

Wed, 23 Sep 2026 18:07:42 +0200

Leverkusen, September 23, 2026 – On Wednesday Bayer AG successfully placed new hybrid bonds for an amount of 2 billion euros, increasing its outstanding volume of hybrid bonds to 6.55 billion euros. Both tranches, one billion euros each, were oversubscribed multiple times, which demonstrates strong market confidence in Bayer AG’s financial strength. The proceeds will be used for general corporate purposes. The transaction follows the 3-billion-euro equity investment from Apollo and the successful placement of bonds with a volume of 5 billion U.S. dollars in the past months.

The hybrid bonds have been sold exclusively to institutional investors. Both tranches have a final maturity of 30 years. The bonds with a non-call period of six years pay a coupon of 5.75 percent and the bonds with a non-call period of nine years pay a coupon of 6.25 percent. Bayer intends to list the hybrid bonds on the Luxembourg Stock Exchange.

BofA Securities and Deutsche Bank acted as Global Coordinators. BNP PARIBAS, BofA Securities, Citigroup, Crédit Agricole CIB, Deutsche Bank and HSBC led the transaction as Active Bookrunners.

Hybrid bonds are a permanent component of Bayer’s financing strategy and support its conservative financial policy. They are structured to receive 50 percent equity credit from the rating agencies (Standard & Poor’s, Moody’s and Fitch).

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to support efforts to master major challenges presented by a growing and aging global population and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Important notice
This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the prospectus to be published in connection with the transaction.

This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129, as amended. The prospectus, when published, will be available on the website of the Luxembourg Stock Exchange (www.luxse.com).

The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons.

Bayer launches mono-material PP blister for Talcid® in Germany

Wed, 23 Sep 2026 11:00:01 +0200

Basel, September 23, 2026 – Bayer has launched a mono-material polypropylene (mono-PP) blister for Talcid^® in Germany, following its initial launch in Slovenia in late 2025. The new blister replaces a multi-material structure with a single-material polypropylene design intended to facilitate recycling in markets where appropriate collection, sorting and recycling systems are available. It maintains the quality, safety and product experience consumers expect from Talcid.

Talcid is Bayer’s antacid treatment for heartburn and acid-related symptoms. Germany accounts for approximately 75% of its European sales, making it the product’s largest market in the region and a significant location for the new packaging. The mono-PP blister is planned for phased rollout across 11 additional European markets over 2026–2027.

The launch comes as consumers and regulators place greater emphasis on packaging that combines product protection with designs that can better support recycling processes. According to McKinsey’s 2025 global consumer packaging survey, the ability to recycle packaging remains one of the sustainability characteristics consumers value most.

Conventional blister packs can combine different materials, which may complicate sorting and recycling. Talcid’s new blister contains only polypropylene, creating a simpler mono-material format while meeting the product-protection and quality requirements for consumer health products. The packaging has received RecyClass Design for Recycling certification, achieving the highest Recyclability Class A rating and a recyclable plastic content score of 98.86%. This reflects the compatibility of the packaging design with recycling processes under the RecyClass assessment methodology.

The certification relates to the packaging design and its assessment under RecyClass Design for Recycling criteria. Using a single material can facilitate sorting and recycling processes where appropriate collection, sorting and recycling systems are available. Actual recycling depends on local infrastructure and may vary between markets. The change applies only to the packaging. Talcid’s formulation, indication, safety profile, quality and usage instructions remain unchanged.

Building on Bayer’s Packaging Innovation

The Talcid launch builds on Bayer’s broader work to develop mono-material blister solutions. In 2024, Bayer introduced the healthcare industry’s first PVC-free polyethylene terephthalate (PET) one-material blister for Aleve in the Netherlands. Although the Talcid and Aleve formats use different materials, both programs simplify packaging structures while maintaining product protection and usability, demonstrating how Bayer is applying the same design principle across its portfolio.

“The promise of this mono-material polypropylene design is that it can improve compatibility with recycling processes where appropriate systems exist, while continuing to provide a strong consumer experience,” said Chris Padain, Vice President and Global Head of Design, Packaging, Product Experience & Sustainability for Bayer’s Consumer Health division. “Its push-through performance supports intuitive use, while the mono-material structure simplifies the packaging design. This is the kind of practical, scalable innovation that can make a meaningful difference across our portfolio.”

The Talcid mono-material PP blister supports Bayer Consumer Health’s broader packaging strategy. Across its portfolio, Bayer is working to improve the compatibility of packaging with recycling processes where suitable infrastructure exists, expand reusable packaging formats and incorporate recycled content where appropriate, and reduce unnecessary packaging materials.

Collaboration Across the Packaging Value Chain

The Talcid blister was developed through collaboration across the packaging value chain, bringing together material expertise, manufacturing capabilities and Bayer’s product, quality and regulatory requirements.

“Developing a mono-material blister for consumer health products requires the material, manufacturing process and product-protection requirements to work together,” said Martin Rank, Head of Sales & Marketing at Etimex Primary Packaging. “Our collaboration with Bayer has turned that technical challenge into a scalable PURELAY^® PP mono-material blister solution for Talcid.”

The new blister is the result of years of collaboration to balance product protection, everyday usability and a mono-material packaging design intended to support sorting and recycling processes where appropriate collection, sorting and recycling systems are available. Talcid continues to be manufactured and supplied from Bayer’s site in Bitterfeld, Germany.

“Germany is Talcid’s largest European market, making it a natural next step for the new blister,” said Tobias Boldt, Consumer Health Cluster Lead for Germany and Austria. “This launch connects Talcid’s strong German heritage with a packaging innovation that is planned to reach consumers across more European markets.”

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact for media inquiries:
Kelly O'Halloran, phone +41 76 371 44 98
Email: kelly.ohalloran@bayer.com

Robigo and Leaps by Bayer Announce Series A Financing to Advance Engineered Biologicals That Protect Yields and Reduce Costs

Thu, 17 Sep 2026 15:00:05 +0200

Cambridge, Mass., September 17, 2026 – Robigo, a biotechnology company engineering no-compromise biological solutions for crop protection, today announced a Series A funding led by Leaps by Bayer with participation from Illumina Ventures, SVG Thrive, Congruent Ventures, and Endeavor8. The round will accelerate the commercial launch of engineered microbial biopesticides combatting fungal diseases in soybeans and specialty crops in the United States, making these biologicals economically viable without sacrificing performance. The round will also support Robigo’s pipeline expansion to target additional soil-borne pathogens in broadacre crops, tapping into an addressable market of $10 billion.

Biologicals, which have long been hailed as the next frontier in agriculture, add another tool to expand the farmer’s arsenal of technologies for targeted pest and disease control. The economic toll of crop disease is staggering, and new solutions to combat this are needed. Sudden Death Syndrome (SDS) in soybeans alone causes an estimated $200–$500 million in annual losses for U.S. soybean farmers, and effective chemistries are costly and limited. Meanwhile, fusarium wilt is currently the #1 disease problem for lettuce and berry growers, making Robigo’s solution an excellent addition to their crop protection toolbox.

Robigo's solutions to address crop diseases are rooted in a fundamentally new approach that leverages synthetic biology to precisely engineer the genetics of living microbes, giving them the traits needed to consistently control pests and disease. The company’s ARGO™ platform delivers rapid programmability with computationally designed active ingredients, enabling novel modes of action that silence the pathogen’s essential genes. The platform delivers unparalleled speed, shortening development from computational design through microbe engineering, lead validation, and field testing to under 20 months, compared with an industry norm of three to five years.

Robigo's engineered microbes are applied as a one-time treatment and continuously produce and deliver ARGO™-designed active ingredients where the plant needs them most. This approach provides season-long protection with no change to grower practices.

“At Robigo, we believe in building on nature’s foundation to engineer biological products that match or exceed the performance of today's chemistries. Growers shouldn't have to choose between a product that works and one that's affordable or sustainable," said Dr. Andee Wallace, Founder & CEO of Robigo.

"The scalability of the ARGO™ platform is what sets Robigo apart,” said Dr. Juergen Eckhardt, EVP and Head of Leaps by Bayer. “They are not just developing a single product but rather building an engine that can rapidly address diverse soil-borne pathogens across broadacre crops. Robigo’s pipeline of crop protection programs targets urgent, devastating diseases and offers a strong complement to Bayer’s crop protection portfolio. Robigo is moving quickly to provide farmers with the tools they need to protect their livelihoods, reduce environmental impact, and ensure a more resilient food system."

Photos and videos are available in this folder.

About Robigo:
Robigo is crop protection without compromise. Powered by its proprietary ARGO™ platform, Robigo engineers biological solutions that outperform synthetic chemistries while delivering healthier soils and supporting a more resilient food system.
www.robigo.bio

About Leaps by Bayer:
Leaps by Bayer aims to solve ten huge challenges or ‘Leaps’ through scientific breakthroughs. As the strategic investment unit of Bayer, Leaps has invested over $2.1 billion in more than 65 companies innovating emerging platforms and technologies in health and agriculture. www.leaps.bayer.com

Find more information at www.bayer.com.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

U.S. FDA approves finerenone for new indication in patients with chronic kidney disease associated with type 1 diabetes

Thu, 17 Sep 2026 08:30:00 +0200

Berlin, September 17, 2026 – Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Kerendia™ (finerenone), a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), for the treatment of adult patients with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). Finerenone (10mg, 20mg) is now indicated to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline and end-stage kidney disease in adults with chronic kidney disease associated with type 1 diabetes.

Approximately 30% of people with type 1 diabetes in the U.S. develop chronic kidney disease, increasing their risk of kidney failure and cardiovascular events. Even with recommended treatments for blood glucose and blood pressure management, many patients remain at risk of kidney disease progression and cardiovascular complications.

“For more than three decades, people with chronic kidney disease and type 1 diabetes have had limited options to address the risk of kidney disease progression," said Dr. Janet McGill, Professor of Medicine in the Division of Endocrinology, Metabolism, and Lipid Research at Washington University School of Medicine in St. Louis, and Co-Chair of the study’s Executive Committee. "The approval of Kerendia to reduce UACR, which is expected to slow chronic kidney disease progression in adults with type 1 diabetes, provides an important new treatment option for a population that has continued to face substantial unmet need.”

“Today’s approval in the U.S. marks an important advance for people living with chronic kidney disease associated with type 1 diabetes—a serious and often under-recognized condition. As the first new FDA-approved treatment option in more than 30 years for this patient population, Kerendia reflects Bayer’s commitment to addressing significant unmet needs and bringing meaningful new treatment options to patients,” said Christine Roth Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

In May 2026, the FDA granted Priority Review designation for Bayer’s supplemental New Drug Application for finerenone for the treatment of adult patients with CKD associated with T1D. The approval of finerenone by the FDA is based on the positive results of the Phase III FINE-ONE study, which were published in the New England Journal of Medicine in March 2026 and presented in November 2025 as “Featured High-Impact Clinical Trial” during the Opening Plenary session of the American Society of Nephrology’s (ASN) Kidney Week. These findings are supported by pooled analyses from the Phase III FIDELIO-DKD and FIGARO-DKD studies in CKD associated with type 2 diabetes (T2D), showing that more than 80% of finerenone's kidney benefit was explained by reductions in UACR.

In the U.S., Kerendia has been approved since 2021 for the treatment of adult patients with CKD associated with type 2 diabetes (T2D), since 2025 for the treatment of adult patients with symptomatic chronic heart failure with left ventricular ejection fraction (LVEF) ≥ 40%, and now for the treatment of adult patients with CKD associated with type 1 diabetes.

About Kerendia^™/ Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

Finerenone so far has been studied in more than 20,000 patients across multiple populations with chronic kidney disease and/or heart failure. Finerenone is the first drug targeting the MR pathway that in five pivotal Phase III studies has demonstrated clinically proven heart and/or kidney benefits across a broad range of patient populations, for patients with HF LVEF ≥40%, CKD associated with T2D, CKD associated with T1D, and CKD without diabetes.

Since 2021, finerenone is marketed as Kerendia™ or, in selected countries, as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan, and the U.S. Finerenone is also approved for the treatment of heart failure with LVEF ≥ 40% in the U.S., Europe, Japan, China, and several other markets. Applications for marketing authorization of finerenone in non-diabetic CKD have been filed in China and Japan; so far, finerenone is not approved in non-diabetic CKD in any country worldwide. With the new approval by the FDA, the U.S. are the only country where Kerendia is approved for the treatment of adult patients with CKD associated with type 1 diabetes.

About FINE-ONE
In FINE-ONE, 242 participants were randomized from more than 80 sites across 9 countries worldwide to receive either finerenone or placebo once daily. In addition, patients in the study received usual therapy to treat symptoms and comorbidities.

FINE-ONE is a global, randomized, placebo-controlled, double-blind, multicenter Phase III study in people with CKD and T1D. In FINE-ONE, finerenone in addition to standard of care significantly reduced the primary endpoint of relative change in urine albumin-to-creatinine ratio, or UACR, by 25% over six months compared with placebo. At Month 3 and at Month 6, UACR reduction with finerenone was 22%, and 28%, respectively, compared to placebo. At any time following baseline, 68.1% of participants receiving finerenone achieved a reduction in UACR of at least 30%, compared with 46.6% receiving placebo. A reduction in UACR of 30% is a threshold established by the American Diabetes Association (ADA) as being associated with slower CKD progression in patients with CKD associated with type 2 diabetes. Reductions in UACR of this magnitude have been shown in prior Phase III studies in adults with CKD and T2D to be associated with a delay in kidney disease progression and a reduction in cardiovascular events. The safety profile of finerenone in FINE-ONE was largely consistent with the existing body of evidence in adults with chronic kidney disease associated with type 2 diabetes.

About Chronic Kidney Disease associated with Type 1 Diabetes
Type 1 Diabetes (T1D) is a chronic autoimmune disorder characterized by destruction of pancreatic beta cells leading to insulin deficiency and requiring lifelong insulin treatment. Among the US population overall, crude estimates for 2018 indicated that 1.4 million adults aged 20 years or older (or 5.2% of all US adults with diagnosed diabetes), reported both having T1D and using insulin.

CKD is a common and potentially deadly condition that is widely underrecognized. CKD progresses silently and unpredictably, with many symptoms not appearing until the disease is well-advanced. CKD is one of the most frequent complications arising from diabetes and is also an independent risk factor of cardiovascular disease. CKD affects approximately 30% of people with T1D. The 2017 global prevalence of CKD due to T1D was an estimated 32.5 per 100,000 individuals.

The clinical course of CKD in people with T1D is characterized by an increased urinary albumin excretion rate, which is a first sign of kidney damage and may progress to macroalbuminuria and decrease in kidney function as measured by estimated glomerular filtration rate (eGFR). The treatment of T1D consists of insulin treatment to control hyperglycemia. In people with T1D, blood glucose intervention targeting HbA1c levels ≤7% can slow onset and progression of kidney disease. Despite guideline-recommended treatment with ACEIs and ARBs, residual risk remains high in people with CKD and T1D, with up to a quarter progressing to end-stage-kidney-disease. CKD associated with T1D significantly increases the risk of kidney failure and cardiovascular events, contributing to CKD being a leading cause of death in T1D.

About Bayer’s Commitment in Cardiovascular, Kidney and Cerebrovascular Diseases
Bayer is a leader in the area of cardiology and is advancing a portfolio of innovative treatments for cardiovascular, kidney and cerebrovascular diseases with high unmet medical needs. The company has set a clear focus on developing therapies to treat such diseases (e.g., heart failure, cardiomyopathies, chronic kidney disease, and stroke), and it is its ambition to take a leading role in the care of patients with these diseases. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development. Together, these products reflect the company’s approach to research, which prioritizes targets and pathways with the potential to impact the way that cardiovascular, kidney, and cerebrovascular diseases are diagnosed and treated.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com
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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Q&A-Bayer advances combined seed and crop protection pipeline and enters phase of blockbuster launches

Tue, 15 Sep 2026 16:37:36 +0200

Abstract

Bayer is implementing its previously announced ambition to bring 10 blockbusters to market over 10 years, each expected to deliver a peak sales potential of at least 500 million euros, and is beginning to launch major Crop Science innovations in key agricultural regions around the world. Plenexos™ insecticide and the Preceon™ Smart Corn System have already started to be commercialized, while Vyconic™¹ and Intacta 5+™¹ are expected in the United States/Canada and Brazil, respectively, in the coming years. In parallel, Bayer announces genome-edited standable soy and development of a herbicide tolerant trait to correspond with the new herbicide Icafolin, and the Crop Science Division continues executing its Five-Year Framework, announced in 2025 to drive growth, resilience and profitability.

Key Facts at a Glance

Bayer is implementing its ambition to bring 10 blockbusters to market over 10 years, each defined as a product expected to deliver a peak sales potential of at least 500 million euros.
Plenexos™ insecticide has been introduced in Colombia, with Mexico, Brazil, and the U.S. set to follow; farmers can use up to 75 percent less active ingredient to control pests compared to other products², and Plenexos™ is anticipated to reach a peak sales potential of 500 million euros by the mid-2030s.
The Preceon™ Smart Corn System is already delivering on-farm value in Mexico, Italy, Spain, and the U.S., with commercial launch in Argentina beginning this year; Bayer targets a market penetration of 26 million acres by 2035.
Vyconic™¹, the industry's first soybean trait stack with tolerance to five herbicides, is expected for introduction next year in the United States and Canada, in elite-performing varieties that have demonstrated a yield increase of more than two bushels per acre.
Intacta 5+™¹ is expected for the 2027/2028 growing season in Brazil, bringing five herbicide tolerances plus new insect protection traits designed specifically for the Brazilian market.
In soy, Vyconic™, Intacta 5+™, and the next generation of herbicide tolerance traits, combined with the newest insect protection traits, are expected to reach a peak sales potential of more than 3 billion euros; Bayer wants to regain trait leadership position in North America by 2032.
Additional blockbusters expected before the end of the decade include fourth-generation corn rootworm protection and the herbicide Icafolin, targeting 750 million euros sales potential in the mid-2030s.
Bayer's AI-powered CropKey platform has helped create a pipeline with more than 15 novel crop protection modes of action currently in the pipeline research phase. One example is a new broad-spectrum fungicide for soy with blockbuster potential that has advanced to phase II.
Under the Five-Year Framework announced in 2025, Bayer has made significant progress on cost reductions, amounting to almost 400 million euros to date, divested five active ingredients, discontinued more than 100 crop protection formulations, and reduced inventory by 500 million euros.
Bayer is entering four new crops at the same time — hybrid wheat, camelina, winter oilseed rape and CoverCress™ — with hybrid wheat planned for sale in Europe and North America by the early 2030s. Wheat is a crop grown on more than 500 million acres worldwide.

Why this matters

Connecting seed and crop protection innovation allows Bayer to deliver whole-farm solutions that help growers manage risk, capture yield potential and improve return on investment, said Rodrigo Santos, Member of the Board of Management of Bayer AG and Head of the Crop Science Division. Collectively, the 10 blockbusters will address pressing farmer challenges and are poised to contribute significantly to Bayer's growth over the coming decade. According to Mike Graham, Head of Crop Science R&D, AI is becoming a core enabler of Bayer's innovation model across seeds, traits, and crop protection innovation, helping advance discovery, improve development efficiency, and translate biological insights into differentiated products for growers faster.

FAQ / Q&A

What did Bayer announce about its Crop Science pipeline and blockbuster launches?

Bayer is implementing its previously announced ambition to bring 10 blockbusters to market over 10 years, and is beginning to launch major Crop Science innovations in key agricultural regions around the world. A blockbuster is defined as a product expected to deliver a peak sales potential of at least 500 million euros.

How much less active ingredient do farmers need with Plenexos™ compared to other products?

Farmers can use up to 75 percent less active ingredient to control pests with Plenexos™ compared to other products². This is based on more than 600 trials (internal/external) from 2021-2025 in Brazil, including trials targeting whiteflies in soybean production, with an application rate of 24 g Plenexos active ingredient/ha versus 100 g active ingredient/ha for imidacloprid².

What market penetration target does Bayer have for the Preceon™ Smart Corn System?

Bayer targets a market penetration of 26 million acres by 2035 for the Preceon™ Smart Corn System, which is already delivering on-farm value in Mexico, Italy, Spain, and the U.S., with commercial launch in Argentina beginning this year.

What is the CropKey platform and how many modes of action are in the pipeline?

CropKey is Bayer's AI-powered R&D platform in Crop Protection, enabling the discovery of new modes of action and the design of targeted molecules, assessing efficacy, safety, and sustainability at the very start of the R&D process. More than 15 novel modes of action are currently in the pipeline research phase, driven by CropKey.

What is genome-edited standable soy?

Bayer is developing soy with improved plant architecture through genome editing to address the challenge that higher-yielding soybean varieties can become more susceptible to leaning or falling over as plant height increases. Combined with Bayer's advanced breeding pipeline, this innovation is expected to create new product concepts that will come to market early in the next decade.

What is Icafolin and what sales potential is expected for it?

Icafolin is a groundbreaking herbicide for which Bayer is simultaneously developing a herbicide tolerance trait —the first time the company is simultaneously developing a new herbicide molecule and a plant trait for tolerance to it. Icafolin is targeting 750 million euros in sales potential in the mid-2030s.

What progress has Bayer made on its Five-Year Framework for Crop Science?

Execution of the Five-Year Framework is fully on track. Bayer has made significant progress on cost reductions, amounting to almost 400 million euros to date, divested five active ingredients, discontinued more than 100 crop protection formulations, and reduced inventory by 500 million euros. Goals include an EBITDA before special items improvement of 1 billion euros, an EBITDA margin before special items in the mid-20s percentage range, and free operating cash flow of more than 3 billion euros by the end of the decade.

Where can I find the full Bayer news release about this announcement?

The full news release can be found here: https://www.bayer.com/media/en-us/bayer-advances-combined-seed-and-crop-protection-pipeline-and-enters-phase-of-blockbuster-launches/

Facts / Entity Block

Company / Division: Bayer AG, Crop Science Division
Release location and date: Huxley, Iowa, September 2, 2026
Key products/initiatives: Plenexos™ (insecticide), Preceon™ Smart Corn System, Vyconic™¹, Intacta 5+™¹, genome-edited standable soy, Icafolin (herbicide), Hybrid Wheat, Camelina, CoverCress, CropKey (AI R&D platform), Five-Year Framework
Regions/Markets: USA, Brazil, Colombia, Mexico, Canada, Argentina, Italy, Spain, Asia, EMEA, Europe, North America
Spokespeople: Rodrigo Santos, Member of the Board of Management of Bayer AG and Head of the Crop Science Division; Mike Graham, Head of Crop Science R&D
Pictures/additional material: https://www.bayer.com/en/us/designing-the-acre
Original source: Bayer news release, "Bayer advances combined seed and crop protection pipeline and enters phase of blockbuster launches," September 2, 2026

Quotes

"We are delivering on the promises we made and bringing a new generation of game-changing products to farmers. By connecting seed and crop protection innovation we can deliver whole-farm solutions that help growers manage risk, capture yield potential and improve return on investment," said Rodrigo Santos, Member of the Board of Management of Bayer AG and Head of the Crop Science Division. "We pursue a very diligent and differentiated strategy for each of our segments, addressing different growth dynamics, farmer needs, and regional and competitive dynamics. Because we have scale, we see having these different business segments together as a significant strategic advantage – one that plays out in what we innovate and how we can serve growers."

“Whether in seeds, traits or crop protection innovation, AI is becoming a core enabler of Bayer’s innovation model, helping us advance discovery, improve development efficiency and translate biological insights into differentiated products for growers faster,” said Mike Graham, Head of Crop Science R&D. “Our advantage is that our teams work from the same biological insights, enabling us to combine expertise across disciplines and accelerate innovation.”

“Our innovation strategy and our Five-Year Framework are built on execution,” said Rodrigo Santos. “We are making progress against the commitments we have made, and are set to lead the industry and bring value to our customers and shareholders by delivering differentiating solutions that growers around the world need.”

Contact for media inquiries:
Alexander Gutmann, phone +49 174 730 6349
Email: alexander.gutmann@bayer.com

Benjamin Eberle, phone +1 314 258 6187
Email: benjamin.eberle@bayer.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Link to the full original news release

https://www.bayer.com/media/en-us/bayer-advances-combined-seed-and-crop-protection-pipeline-and-enters-phase-of-blockbuster-launches/

Notes

1 These products are not currently available for commercial sale or commercial planting. Commercialization is dependent on multiple factors, including successful conclusion of the regulatory process. The information presented herein is provided for educational purposes only, and is not and shall not be construed as an offer to sell.

2 Based upon >600 trials (internal/external) from 2021-2025 in Brazil, including trials with Plenexos™ targeting whiteflies in soybean production; application rate 24 g ai/ha vs. imidacloprid 100 g ai/ha.

U.S. FDA grants accelerated approval to Bayer’s targeted therapy sevabertinib as a first-line treatment option for adults with HER2-mutant non-small cell lung cancer

Wed, 09 Sep 2026 20:20:02 +0200

Berlin, September 9, 2026 – Following Priority Review and Breakthrough Therapy Designation, the U.S. Food and Drug Administration (FDA) has granted accelerated approval for sevabertinib as a first-line treatment option for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test. Sevabertinib is an oral, reversible, small molecule, tyrosine kinase inhibitor (TKI).

“The FDA’s accelerated approval of sevabertinib marks an important advance for treatment-naïve patients with HER2-mutated NSCLC who historically have a poor prognosis,” said SOHO-01 lead investigator, Xiuning Le, MD, PhD, associate professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, Texas. “This milestone also underscores the critical importance of comprehensive molecular testing at diagnosis, including for activating HER2 mutations, to ensure patients receive the most appropriate treatment as early as possible.”

The FDA approved this indication for sevabertinib under accelerated approval based on objective response rate (ORR) and duration of response (DOR) demonstrated in a cohort of treatment-naïve patients (N=69) in the ongoing Phase I/II SOHO-01 trial (NCT05099172), evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2-mutant NSCLC. In this cohort, the ORR was 75% including complete responses in 6% of patients and partial responses in 70% of patients, with 73% of responders maintaining response for at least six months. The safety profile of sevabertinib was consistent with previous findings. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing Phase III SOHO-02 confirmatory trial (NCT06452277), which is evaluating sevabertinib versus standard of care in treatment-naïve patients with advanced HER2-mutant NSCLC.

“Today’s FDA approval of sevabertinib as an initial treatment option for locally advanced or metastatic non-squamous HER2-mutated NSCLC is an important milestone for patients and a powerful validation of Bayer’s commitment to advancing precision oncology in areas with the highest unmet needs,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Lung cancer remains the leading cause of cancer-related deaths worldwide and for patients with HER2-mutated NSCLC, a distinct subtype that often affects people who have never smoked, there remains a critical need for additional treatment options. This approval underscores the potential of precision medicine to transform outcomes by matching the right patients to the right therapy at the right time.”

In November 2025, sevabertinib received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2-targeted therapy and cohort E - patients who had previously received HER2-directed antibody-drug conjugates). Earlier this year, sevabertinib was also approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. The approval follows the Center for Drug Evaluation (CDE) in China granting sevabertinib Breakthrough Therapy Designation for this patient population. The CDE has also granted sevabertinib Breakthrough Therapy Designation to expedite its development for first-line use in patients with advanced HER2-mutant NSCLC. Sevabertinib has also recently been approved as the first approved targeted therapy for this indication that can be used regardless of line of therapy, including as a first-line treatment, by the Ministry of Health, Labour, and Welfare in Japan.

About sevabertinib
Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2, including HER2 exon 20 insertions and HER2 point mutations. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.

As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2-mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with HER2-activating mutations, excluding advanced NSCLC.

About Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2-mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies.

About Oncology at Bayer
Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer’s focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread.

Find more information at https://pharma.bayer.com
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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Bayer and Neste close commercial agreement to jointly scale newgold® winter canola for biofuels production

Wed, 09 Sep 2026 14:00:01 +0200

Monheim, Germany/St. Louis, USA, September 9, 2026 – Bayer and Neste, the world’s leading producer of renewable diesel and sustainable aviation fuel, have finalized a commercial agreement to jointly scale Bayer’s newgold^® winter canola.

The collaboration will enable Bayer to significantly expand acres of winter canola in the Southern Great Plains of the US, strengthening the oilseed supply potential of lower-carbon-intensity feedstocks to meet the growing global demand for biofuels such as renewable diesel and sustainable aviation fuel, which is estimated to increase almost threefold reaching approximately 40 billion gallons by 2040.^1,2 The high protein meal from the winter canola grain will be sold into the feed market, offering additional feed sources for dairy and beef cattle, poultry and swine markets.

“In times of geopolitical tensions, the need for more energy security and resilience while decarbonizing the transportation sector leads to growing demand for renewable fuel. This agreement further underscores Bayer’s commitment to help scale biofuels production,” said Frank Terhorst, Head of Strategy and Sustainability for Bayer’s Crop Science division. “We see the Southern Great Plains as an untapped opportunity for winter canola. The launch of newgold^® winter canola will provide farmers with a profitable rotational crop with wheat and improve land utilization, while offering the opportunity to participate in a growing biofuels market.”

Bayer and Neste are establishing a newgold^® network with additional value chain partners, to support the expansion of winter canola and ensure an additional market for farmers.

“Maximizing the contribution of novel types of raw materials to support growth in renewables requires open supply chain collaboration. By building robust value chains, we can turn agricultural innovations into scalable realities for growers and energy markets. Through the Bayer newgold^® winter canola collaboration, we are establishing a value chain in one of Neste’s key markets and developing opportunities to increase farm yields and grower income. This renewable raw material can be scaled rapidly in the coming years, which can help meet increasing biofuels demand,” says Artturi Mikkola, Senior Vice President, Renewable Products Feedstock Sourcing and Trading at Neste.

Bayer aims to launch newgold^® winter canola hybrids in the fall of 2027. These hybrids offer farmers several benefits, including winter-hardiness, TruFlex^®, Bayer’s second-generation Roundup Ready trait technology, and pod shatter resistance technology. Together, these advancements can deliver strong potential for yield performance and higher oil content. TruFlex winter canola, sold under the newgold^® seed brand, will be designed with the goal of acting as a new profit opportunity for the Southern Great Plains, giving growers the flexibility to decide how and where it fits best in their operation.

Biofuels can play a key role in helping the transportation sector in its energy transition since electrification may not be feasible in all transportation systems like aviation, rail, heavy duty equipment or marine. Biofuels can be produced from renewable organic materials like corn, soy, canola and other intermediate oilseed crops, such as winter canola. Bayer recently presented its biofuels platform at its investor day in Huxley, IA, where it highlighted its emergent, but leading portfolio of intermediate biofuel crops, including camelina, winter canola and CoverCress™.

Notes

¹U.S. Energy Information Administration and Bayer internal estimates
²McKinsey and Bayer internal estimates.

About Neste
Neste (NESTE, Nasdaq Helsinki) is the world's leading producer of renewable diesel and sustainable aviation fuel (SAF), with production on three continents. The company’s renewables production capacity is expected to reach 6.8 million tons annually in 2027. Neste also produces high-quality oil products at its Porvoo refinery in Finland. The company has a network of nearly 1,000 fuel stations with expanding service offering, such as EV charging, in Finland and in the Baltics. Neste’s strategy focuses on growth in renewable fuels, which help its customers to reduce their greenhouse gas emissions. Neste is included in many international indices for its sustainability performance. In 2025, Neste's revenue stood at EUR 19.0 billion. Read more: neste.com. Please subscribe to Neste’s releases at https://www.neste.com/media/subscribe.

Find more information at www.bayer.com.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

Contact for media inquiries:
Bayer (global)
Alexander Hennig, +49 175 3089736
Email: alexander.hennig@bayer.com

Bayer (US)
Kyel Richard, +1 573 356-0241
Email: kyel.richard@bayer.com

Neste
Media Service, +358 800 94025
Email:media@neste.com

Contact for investor inquiries:
Bayer Investor Relations Team, phone +49 214 30-72704
Email: ir@bayer.com
www.bayer.com/en/investors/ir-team

Bayer initiates Phase II study of investigational GIRK4 inhibitor in patients with atrial fibrillation

Wed, 09 Sep 2026 08:30:02 +0200

Berlin, September 9, 2026 – Bayer announced today the initiation of a global Phase II clinical trial (NCT07625215) evaluating BAY 3670549, an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, which has the potential as a new approach to control the electrical activity of heart cells in patients with atrial fibrillation (AFib). The Phase II single-treatment study in a randomized, double-blind, placebo-controlled, parallel-group, multi-cohort design, will investigate the efficacy, safety and tolerability, as well as pharmacodynamics and pharmacokinetics of BAY 3670549 in adult patients with AFib. BAY 3670549 demonstrated a favorable safety and tolerability profile in healthy participants in the completed first-in-human single-ascending-dose Phase I study, supporting its continued clinical advancement and strengthening Bayer’s cardiovascular development portfolio.

“The start of the Phase II marks an important step in our commitment to redefining what may be possible in cardiovascular care, with GIRK4 inhibition carrying the potential to meaningfully advance the treatment of atrial fibrillation, a condition affecting millions of people worldwide,” said Dominik Ruettinger, M.D., Ph.D., Head of Research and Early Development at Bayer’s Pharmaceuticals Division. “We are advancing this program because patients and physicians need fast-acting and well-tolerated treatment options that can make a real difference.”

BAY 3670549, which emerged from Bayer’s strategic research alliance with the Broad Institute, is being investigated as a novel approach for rapid cardioversion to normal sinus rhythm. If successful, it could provide a fast-acting and well-tolerated treatment option that may help reduce the burden on both patients and healthcare systems by offering a potential alternative to electrical cardioversion, the current gold standard for AFib, which often requires anesthesia or sedation, external defibrillation and prolonged hospital-based care.

AFib is the most common type of sustained cardiac arrhythmia (irregular heart rhythm), affecting more than 60 million people worldwide, and a significant risk factor for stroke and heart failure.^4,5,6

About GIRK4 inhibitor (BAY 3670549)
BAY 3670549 is an investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor being evaluated as a potential new approach to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib).

GIRK4 channels are specialized proteins that regulate the electrical activity of heart cells by facilitating the flow of potassium ions (K+) in response to the neurotransmitter acetylcholine (ACh). This mechanism is particularly crucial during the later phases of the heart’s electrical signaling, specifically during the atrial effective refractory period (AERP). Increased activity of these channels shortens the AERP in the atria (the upper chambers of the heart), thereby reducing the recovery time after each heartbeat. This alteration in recovery time can contribute to the onset and persistence of AFib.

About the study (NCT07625215)
A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase II study will investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with AFib.

The study will compare BAY 3670549 to a placebo in patients with AFib who need a treatment called electrical cardioversion. Electrical cardioversion is a procedure that helps the heart return to a normal rhythm.

In the Phase I study, BAY 3670549 was proven to be well-tolerated in healthy male and female participants.

About Atrial fibrillation
AFib is one of the most common sustained cardiac rhythm disorders (arrhythmias). It results from rapid, disorganized electrical signals in the upper chambers (atria) of the heart, causing them to quiver and contract quickly and irregularly. As a result, the atria do not empty efficiently, leading to impaired blood flow and an increased risk of blood clot formation. These clots can break loose, travel to the brain, and cause a stroke. In addition, AFib disrupts the coordinated function of the upper and lower chambers of the heart, impairing overall cardiac performance and leading to symptoms such as palpitations, shortness of breath, fatigue, and a reduced quality of life in many patients.

The prevalence of AFib continues to increase globally. Projection studies show that the number of people with AFib will rise to 15.9 million in 2050 in America and 17.9 million in 2060 in Europe.⁷ People with AFib are 5 times more likely to suffer a stroke than people without AFib.⁸ AFib-related strokes are also associated with a 50% likelihood of death within one year.⁹

The current gold standard to treat acute AFib episodes is electric cardioversion (ECV). This is an effective but resource-intensive and logistically challenging procedure, which is normally scheduled in advance and typically requires sedation or even anesthesia to safely deliver an electrical shock to the patient and restore the heart to its normal sinus rhythm.^10,11 On the other hand, currently available anti-arrhythmic drugs (AADs), which are commonly used for the management of symptomatic AFib, can’t be applied to broad patient populations due to a number of contraindications (such as for patients with structural heart disease) and safety risks, including abnormal heart rhythms and sudden death. Additionally, they show limited, short-term efficacy, require close monitoring and bear the risk of serious side effects.^12,13

Find more information at https://pharma.bayer.com
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Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

¹ Atrial fibrillation: epidemiology, screening and digital health, Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786

² American Heart Association, Why Atrial Fibrillation Matters | American Heart Association

³ Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities, Heart 2021;107:516-518.

⁴ Atrial fibrillation: epidemiology, screening and digital health, Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786

⁵ American Heart Association, Why Atrial Fibrillation Matters | American Heart Association

⁶ Kornej J, Benjamin EJ, Magnani JW, Atrial fibrillation: global burdens and global opportunities, Heart 2021;107:516-518.

⁷ Atrial fibrillation: epidemiology, screening and digital health, Linz, Dominik et al., The Lancet Regional Health – Europe, Volume 37, 100786

⁸ Singleton MJ, Imtiaz‐Ahmad M, Kamel H, O'Neal WT, Judd SE, Howard VJ, Howard G, Soliman EZ, Bhave PD. Association of atrial fibrillation without cardiovascular comorbidities and stroke risk: from the REGARDS study. Journal of the American Heart Association. 2020 Jun 16;9(12):e016380.

⁹ Alberts M, Chen YW, Lin JH, Kogan E, Twyman K, Milentijevic D. Risks of Stroke and Mortality in Atrial Fibrillation Patients Treated With Rivaroxaban and Warfarin. Stroke. 2020 Feb;51(2):549-555. doi: 10.1161/STROKEAHA.119.025554. Epub 2019 Dec 31. PMID: 31888412; PMCID: PMC7004448.

¹⁰ Nusair M, Flaker GC, Chockalingam A. Electric cardioversion of atrial fibrillation. Mo Med. 2010 Jan-Feb;107(1):59-64. PMID: 20222298; PMCID: PMC6192814.

¹¹ Why Atrial Fibrillation Matters | American Heart Association

¹² Andrade JG. Ablation or drug therapy for initial atrial fibrillation. Ann Cardiothorac Surg 2024;13(1):71-76. doi: 10.21037/acs-2023-afm-0159

¹³ Journal Article, Zimetbaum, Peter, Antiarrhythmic Drug Therapy for Atrial Fibrillation 2012, Circulation 381-389, 125, N 2 doi:10.1161/CIRCULATIONAHA.111.019927,https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.111.019927

Bayer advances combined seed and crop protection pipeline and enters phase of blockbuster launches

Wed, 02 Sep 2026 14:00:01 +0200

Huxley, Iowa, September 2, 2026 – Bayer is implementing its previously announced ambition to bring 10 blockbusters to market over 10 years, beginning to launch major Crop Science innovations in key agricultural regions around the world. A blockbuster is a product that is expected to deliver a peak sales potential of at least 500 million euros. Plenexos™ insecticide and the Preceon™ Smart Corn System have already started to be commercialized. In soy, Vyconic™ ¹ is expected for introduction next year in the United States and Canada, and Intacta 5+™¹ introduction is expected for the 2027/2028 growing season in Brazil.

“We are delivering on the promises we made and bringing a new generation of game-changing products to farmers. By connecting seed and crop protection innovation we can deliver whole-farm solutions that help growers manage risk, capture yield potential and improve return on investment,” said Rodrigo Santos, Member of the Board of Management of Bayer AG and Head of the Crop Science Division. “We pursue a very diligent and differentiated strategy for each of our segments, addressing different growth dynamics, farmer needs, and regional and competitive dynamics. Because we have scale, we see having these different business segments together as a significant strategic advantage – one that plays out in what we innovate and how we can serve growers.”

The Preceon™ Smart Corn System, a digitally enabled short-stature corn system, is already delivering on-farm value in Mexico, Italy, Spain, and the U.S. This year, the commercial launch in Argentina will begin. It delivers a unique combination of benefits for growers, including increased protection against weather extremes, flexibility to plant at higher densities, improved accessibility for standard farm equipment throughout the season, and a larger root system, all supporting reduced agronomic risk, higher yield potential and better return on investment for farmers. By 2035, Bayer targets a market penetration of 26 million acres. Preceon™ is also unique by embedding digital capabilities within the system through FieldView™. More than a sales enablement platform, it serves as a collaboration tool between farmers and their agronomic advisors and helps customers realize the full agronomic and economic potential of the system.

Plenexos™, a new insecticide targeting a broad spectrum of sucking pests, has been introduced in Colombia, with Mexico, Brazil, and the U.S. set to follow. Compared to other products, farmers can use up to 75 percent less active ingredient to control pests² which also helps safeguard pollinators, beneficial insects and other non-target organisms. With a focus on soy, cotton, fruits and vegetables, Plenexos™ is anticipated to reach a peak sales potential of 500 million euros by the mid-2030s.

Vyconic™ will be the industry's first soybean trait stack with tolerance to five herbicides. It is designed to provide growers with more flexibility in their weed control options and to better manage weed pressure and increasingly problematic resistance. Because of the integration with Bayer’s advanced breeding pipeline, Vyconic™ will be introduced in elite-performing varieties that have demonstrated a yield increase of more than two bushels per acre, meaning that farmers realize the full value of both increased genetic yield potential and weed control flexibility earlier than ever. Bayer anticipates strong adoption of Vyconic™ and subsequent launch of HT5, helping to regain trait leadership position in North America by 2032. Intacta 5+™ will also bring five herbicide tolerances to Brazilian growers, and adds new insect protection traits specifically designed for the Brazilian market. In soy, these and the next generation of herbicide tolerance traits, combined with the newest insect protection traits, are expected to reach a peak sales potential of more than 3 billion euros.

Additional blockbusters expected before the end of the decade include fourth-generation corn rootworm protection, as well as the groundbreaking herbicide Icafolin, targeting 750 million euros sales potential in the mid-2030s. Collectively, the 10 blockbusters will address pressing farmer challenges and are poised to contribute significantly to Bayer's growth over the coming decade.

Bayer advances industry-leading innovation pipeline

Alongside these launches, Bayer advances key projects across its Crop Science R&D pipeline and brings innovation to farmers continuously, introducing 400 to 500 new hybrids and varieties annually. This output is based on Bayer’s AI-enabled precision breeding platform, which doubles the yield improvement rate of every new generation (genetic gain) compared to historical breeding, and accelerates time to market threefold.

The company’s researchers have further enhanced this breeding approach through genome editing, which they use at scale by integrating the technology early in breeding processes. One example is genome-edited soy: Higher-yielding soybean varieties can become more susceptible to leaning or falling over as plant height increases. Through genome editing, Bayer is developing soy with improved plant architecture to help address this challenge. Innovations like genome-edited standable soy and the advanced breeding pipeline come together to create new product concepts and value for growers that will come to the market early in the next decade.

As another example of its connected R&D engine, Bayer is advancing new biotech traits in concert with its novel crop protection innovation. In early-stage development, the company is working on its sixth-generation herbicide tolerance, which is expected to also include tolerance against its blockbuster herbicide Icafolin. It is the first time the company simultaneously develops a new herbicide molecule and plant trait for tolerance, contributing to a holistic weed-control system that is unique in the industry.

Bayer’s AI-powered R&D-CropKey platform is a key differentiator in Crop Protection, enabling the discovery of new modes of action and the design of targeted molecules assessing efficacy, safety, and sustainability at the very start of the R&D process. This has helped create a robust pipeline with more than 15 novel modes of action currently in the pipeline research phase, driven by CropKey. One example is a new broad-spectrum fungicide for soy with blockbuster potential. It is developed using CropKey and now advanced to phase II in the pipeline.

Bayer is also using its unique R&D capabilities to expand into adjacent growth areas. With its emergent, but leading portfolio of intermediate biofuel crops, including camelina, winter oilseed rape and CoverCress™, the company contributes to meeting growing demand for biodiesel, renewable diesel and sustainable aviation fuel markets, estimated to increase almost threefold to 40 billion gallons by 2040. Bayer is also advancing its plans to sell hybrid wheat in Europe and North America by the early 2030s. This unlocks a largely untapped opportunity by bringing the benefits of hybridization to a crop grown on more than 500 million acres worldwide. With hybrid wheat, camelina, winter oilseed rape and CoverCress™, Bayer is entering four new crops at the same time.

Bayer on track executing its Five-Year Framework

Bayer’s innovation approach is enabled by execution of its Five-Year Framework strategy, which the Crop Science Division announced in 2025 to drive growth, resilience and profitability. The company continues to execute the strategy, and efforts are beginning to deliver tangible results.

Bayer has made significant progress on cost reductions, amounting to almost 400 million euros to date, contributing to its EBITDA before special items improvement goal of 1 billion euros and supporting its ambition to achieve an EBITDA margin before special items in the mid-20s percentage range by the end of the decade. Actions included divesting five active ingredients and discontinuing more than 100 crop protection formulations. In addition, cash-flow measures are progressing, with inventory reductions of already 500 million euros, supporting Bayer’s ambition to reach a free operating cash flow of more than 3 billion euros by 2029.

The Five-Year Framework’s goal of above-market growth and delivering more than 3.5 billion euros of incremental sales at constant currency through the end of the decade is supported by Bayer’s ongoing innovation delivery as well as strategic business decisions. Key growth drivers include excellent-yielding hybrids launched every year, accelerated technology adoption, market share gains and geographic expansion of proven technologies into Asian and EMEA markets. In the crop protection space, Bayer is pursuing growth through locally focused go-to-market initiatives, redeploying commercial resources to growth products and regions, and lifecycle management measures, like the introduction of Convintro™ in the United States, Brazil and Canada.

Bayer’s progress is supported by its Dynamic Shared Ownership operating model, which enables faster decisions and clearer accountability, strengthening the company’s ability to lead in scaling AI-enabled opportunities across the business. “Our innovation strategy and our Five-Year Framework are built on execution,” said Rodrigo Santos. “We are making progress against the commitments we have made, and are set to lead the industry and bring value to our customers and shareholders by delivering differentiating solutions that growers around the world need.”

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Notes

¹These products are not currently available for commercial sale or commercial planting. Commercialization is dependent on multiple factors, including successful conclusion of the regulatory process. The information presented herein is provided for educational purposes only, and is not and shall not be construed as an offer to sell.

²Based upon >600 trials (internal/external) from 2021-2025 in Brazil, including trials with Plenexos™ targeting whiteflies in soybean production; application rate 24 g ai/ha vs. imidacloprid 100 g ai/ha.

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

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Phase III REVEAL Study with Investigational PET Radiotracer Iodine 124 Evuzamitide Presented as Late-Breaker at ESC 2026

Sun, 30 Aug 2026 13:50:04 +0200

Berlin, Germany, August 30, 2026 – Bayer today announced first detailed results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital, that evaluated the investigational positron emission tomography (PET) radiotracer iodine 124 evuzamitide (I 124 evuzamitide) for the diagnosis of cardiac amyloidosis.¹ The pivotal study met its primary endpoints in the assessment of sensitivity and specificity for the diagnosis of cardiac amyloidosis based on visual scan interpretation.¹Secondary endpoints, which assessed diagnostic performance in light-chain amyloidosis (AL) as well as in transthyretin amyloidosis (ATTR) based on visual scan interpretation, also met the predefined success criteria in the overall population. I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.

These results were shared in a late-breaking oral presentation at the European Society of Cardiology Congress 2026 (ESC) in Munich, Germany, on August 30, 2026, and simultaneously published in The Journal of the American Medical Association.

“For people with cardiac amyloidosis, obtaining an accurate diagnosis can be challenging,” said REVEAL principal investigator Dr. Sharmila Dorbala, Director of Nuclear Cardiology, Brigham and Women’s Hospital, Director of Amyloidosis Research, Mass General Brigham Heart & Vascular Institute. “These challenges can lead to delays, underdiagnosis or misdiagnosis in the course of the disease .”

“ Bayer is proud to present this new research on cardiac amyloidosis at ESC,” said Dr. Erin Bowman, Senior Medical Director of Molecular Imaging and Theranostics at Bayer. “The presentation of this data reflects our ongoing commitment to advancing research for patients affected by this disease.”^2,3

Key Highlights of the Phase III REVEAL Study Results and Design

REVEAL was a multicenter, open-label, single-arm Phase III study conducted at 18 centers in the United States, evaluating 170 adults with suspected cardiac amyloidosis.

Primary analyses from the Phase III REVEAL study showed the investigational PET radiotracer I 124 evuzamitide met the primary efficacy endpoints of sensitivity (the ability to identify individuals who have the condition) and specificity (the ability to identify individuals who do not have the condition) for the diagnosis of cardiac amyloidosis based on visual scan interpretation from three independent readers.

o Sensitivity

- Reader 1: 94% (95% confidence interval [CI], 85% to 98%)
- Reader 2: 94% (95% CI, 85% to 98%)
- Reader 3: 90% (95% CI, 81% to 95%)

o Specificity

- Reader 1: 84% (95% CI, 75% to 91%)
- Reader 2: 85% (95% CI, 76% to 92%)
- Reader 3: 89% (95% CI, 81% to 95%)

Based on the majority read (agreement between at least two out of three readers), sensitivity was 94% (95% CI, 85% to 98%) and specificity was 86% (95% CI, 77% to 92%).
Secondary efficacy endpoints, which assessed diagnostic performance in light-chain amyloidosis (AL) as well as in transthyretin amyloidosis (ATTR) based on visual scan interpretation, also met the predefined success criteria for the total population of patients with suspected cardiac amyloidosis.

o For the ATTR type, sensitivity from the majority read was 96% (95% CI, 87% to 100%) and specificity was 86% (95% CI, 77% to 92%).
o For the AL type, sensitivity from the majority read was 95% (95% CI, 76% to 100%) and specificity was 86% (95% CI, 77% to 92%).

Among the 170 patients who received I 124 evuzamitide, 55 (32.4%) experienced at least one treatment-emergent adverse event (TEAE) from Day 1 to Day 30. Of these, 11 (6.5%) patients experienced a serious TEAE unrelated to I 124 evuzamitide; only one TEAE (fatigue) was considered related to I 124 evuzamitide.
The most common TEAEs, occurring in >1% of participants, were upper respiratory tract infection (2.9%), dizziness (2.4%), nausea (1.8%), vomiting (1.8%), syncope (1.8%), hyperglycemia (1.8%) and skin laceration (1.8%).

o There were no deaths or evuzamitide related TEAEs leading to discontinuation during the study period.

About Iodine 124 Evuzamitide
Iodine 124 evuzamitide (I 124 evuzamitide) is an investigational PET radiotracer – a radioactive diagnostic imaging agent injected into the body before a PET scan to assist with visualization – being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide, also known as AT-01, is one of two investigational amyloid radiotracers that Bayer acquired from Attralus, Inc.⁴The acquisition expands Bayer’s radiology pipeline with complementary tracers targeting systemic amyloid disease.

Regulatory Status of I 124 Evuzamitide
I 124 evuzamitide was previously granted Breakthrough Therapy Designation by the U.S. FDA for PET imaging in patients with suspected or known cardiac amyloidosis. It was also granted Orphan Drug status for both AL and ATTR in the U.S. and the EU.⁵ I 124 evuzamitide is currently under investigation and has not been approved by any health authority for use in any country for any indication. Bayer plans to discuss these data and submission for regulatory approval with the FDA and other health authorities.

About the REVEAL Study⁶
The REVEAL (“Research with EVuzamitide I 124 to Elucidate Cardiac AmyLoidosis”) study was an investigator-initiated Phase III clinical trial of the investigational diagnostic imaging agent I 124 evuzamitide in patients with suspected cardiac amyloidosis. Brigham and Women’s Hospital in Boston, MA, was the study sponsor.

The main purpose of the study was to evaluate the efficacy and safety of the investigational radiotracer I 124 evuzamitide for diagnosing cardiac amyloidosis in participants with suspected cardiac amyloidosis compared to clinical standard of truth diagnosis based on available clinical data. Secondary analyses assessed diagnostic performance in ATTR and AL subtypes. The imaging test used in this study was a positron emission tomography (PET) scan.

Participants received a single intravenous dose of I 124 evuzamitide, followed by cardiac and partial-body PET/CT imaging, 3-5 hours post-injection. All PET/CT images were independently read by experienced cardiac PET physicians, assessing visual presence or absence of cardiac tracer uptake, blinded to clinical data.

Cases were confirmed through an independent clinical adjudication committee, blinded to PET results, with expertise in cardiology, amyloidosis, and/or cardiac imaging. The committee established standard of truth using diagnostic data collected up to 60 days after imaging.

About Cardiac Amyloidosis
Cardiac amyloidosis is a severe, progressive disease caused by the accumulation of misfolded proteins (amyloid) in heart tissue, making it stiff and thick, which can impair its ability to pump blood effectively.⁷ Despite increasing disease awareness by health care providers, a prolonged diagnostic journey is common, with patients often consulting several specialists and receiving multiple tests and procedures before an accurate diagnosis.³ Without timely diagnosis and treatment, cardiac amyloidosis can lead to heart failure, frequent hospitalizations and early mortality.⁸ Currently, there is no single, non-invasive test that can reliably detect and diagnose cardiac amyloidosis or quantify and monitor myocardial amyloid burden.²

About Molecular Imaging
Molecular imaging allows clinicians to visualize and quantify biological processes at the molecular and cellular level in real time, enabling earlier disease detection and personalized treatment planning.⁹

About Radiology at Bayer
Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer’s comprehensive offerings also include informatics solutions. In 2025, Bayer’s radiology products generated €2.2 billion in sales. Bayer continues to advance research and innovation in medical imaging, including in molecular imaging and other promising fields.

Find more information at https://pharma.bayer.com
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Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.

¹ Data on file

² Briasoulis A, et al. Invasive and Non-Invasive Diagnostic Pathways in the Diagnosis of Cardiac Amyloidosis. J Cardiovasc Dev Dis. 2023 Jun 11;10(6):256. doi: 10.3390/jcdd10060256.

³ Dang D, et al. Gateway and journey of patients with cardiac amyloidosis. ESC Heart Fail. 2020 Oct;7(5):2418-2430. doi: 10.1002/ehf2.12793.

⁴ Bayer. Bayer to expand into molecular imaging with acquisition of innovative pan-amyloid radiotracers from Attralus. Published January 12, 2026. Accessed July 24, 2026. Bayer press release

⁵ Bayer. Investigational PET Tracer Iodine 124 Evuzamitide from Bayer Met Primary Endpoints in Phase III Study in Patients Suspected to Have Cardiac Amyloidosis. Bayer. Published May 7, 2026. Accessed July 24, 2026. Bayer press release.

⁶ Clinicaltrials.gov. Research With I-124 EVuzamitide to Elucidate Cardiac AmyLoidosis (REVEAL). https://clinicaltrials.gov/study/NCT06788535

⁷ Cleveland Clinic. Cardiac amyloidosis: What you need to know. Updated October 13, 2025. Available at: https://my.clevelandclinic.org/health/diseases/22598-cardiac-amyloidosis

⁸ Dentamaro I, et al. Cardiovascular Prognosis in Stable Patients with Cardiac Amyloidosis: A Novel and Simple Risk Score. J Clin Med. 2026 Mar 7;15(5):2045. doi: 10.3390/jcm15052045.

⁹Society of Nuclear Medicine & Molecular Imaging. What is Nuclear Medicine and Molecular Imaging? Accessed July 6, 2026. Available at: https://snmmi.org/Patients/Patients/Fact-Sheets/What-is-Nuclear-Medicine-and-Molecular-Imaging.aspx

Finerenone slowed kidney function decline and reduced kidney-cardiovascular risk versus placebo in patients with hypertensive nephropathy

Sun, 30 Aug 2026 13:44:43 +0200

Berlin, August 30, 2026 – Positive results from a pre-specified subgroup analysis of the Phase III FIND-CKD trial were presented today during a Late-Breaking Clinical Science session at ESC Congress 2026 in Munich, Germany. The analysis showed that finerenone (Kerendia™/Firialta™) slowed kidney function decline and reduced kidney-cardiovascular risk compared with placebo, in addition to standard of care, in patients with hypertensive nephropathy.

“Hypertension is one of the most common causes of chronic kidney disease, yet there are still very few treatments that have been shown to address the high risk of kidney function decline and cardiovascular events in adults with chronic kidney disease attributed to hypertension,” said Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Co-Chair of the FIND-CKD study's Executive Committee. “For clinicians, the findings offer new insights into the benefits of finerenone in cardio-kidney health protection in patients with hypertensive nephropathy.”

Key findings from the pre-specified FIND-CKD subgroup analysis

For the subgroup analysis, 459 patients with hypertensive nephropathy out of the 1,584 participants randomized in FIND-CKD (29.0%) were included, with 234 patients randomized to receive finerenone and 225 randomized to placebo. The primary outcome of the FIND-CKD study was estimated glomerular filtration rate (eGFR) change over time from baseline to 32 months (= total eGFR slope). The eGFR slope is a validated surrogate endpoint for clinical kidney outcomes. In the subgroup, eGFR slope decline was slower with finerenone compared to placebo (−3.17 vs. −3.82 mL/min/1.73 m² per year; a between-arm difference of 0.65 mL/min/1.73 m² per year [95% CI, 0.02–1.29; p=0.044]). Finerenone also reduced the risk of the key secondary kidney-cardiovascular endpoint, a composite of kidney failure, sustained ≥57% decline in eGFR, hospitalization for heart failure, or cardiovascular death, which occurred in 12.0% of patients receiving finerenone compared with 18.7% receiving placebo (hazard ratio [HR], 0.61; 95% CI, 0.38–0.99; p=0.045) in this subgroup.

At month 6, urine albumin-to-creatinine ratio (UACR) was reduced in patients receiving finerenone by 33% (95% CI, 23–41). Finerenone reduced systolic blood pressure at month 6 compared with placebo with a between-group difference of −3.5 mmHg (95% CI: −6.0 to –1.0). Finerenone was well-tolerated in this subgroup, which is consistent with the safety profile observed in the overall FIND-CKD trial population and consistent with the well-established safety profile of finerenone.

High unmet need in patients with hypertension-related CKD

Worldwide, approximately 850 million people are living with CKD, with hypertension-related kidney disease being the second most common cause of kidney failure globally. Patients with advanced non-diabetic CKD across diverse etiologies face a significantly increased risk of fatal cardiovascular events, about 2.6 times higher than that of the general population without CKD, with the risk increasing further as kidney function declines. Despite current standard of care, many of these patients continue to experience disease progression, highlighting the need for new treatment approaches. Overactivation of the mineralocorticoid receptor (MR) is a key contributor to the underlying pathophysiology of both hypertension and CKD.

“This prespecified subgroup analysis adds to the breadth and depth of the robust evidence supporting the clinical utility of finerenone seen so far across its clinical development program in heart failure and chronic kidney disease, while deepening our understanding of its potential benefits in patients with diverse causes of chronic kidney disease,” said Dr. Christian Rommel, Global Head of Research and Development at Bayer’s Pharmaceuticals Division. “The consistency of the data generated to date reinforces our confidence in finerenone and our commitment to advancing research that may help improve outcomes for patients living with cardio-kidney conditions.”

Finerenone is marketed as Kerendia™ or, in some countries as Firialta™, and approved for the treatment of adult patients with CKD associated with type 2 diabetes (T2D) in more than 100 countries worldwide, including in China, Europe, Japan and the U.S. Finerenone is also approved for the treatment of heart failure with LVEF ≥40% in the U.S., Europe, Japan, China, and several other markets. Finerenone is currently not approved for the treatment of non-diabetic CKD.

About Kerendia^™/ Firialta^™ (finerenone)
Kerendia™ and Firialta™ are globally protected trademarks for finerenone. Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) that has been shown to block harmful effects of MR overactivation. MR overactivation contributes to chronic kidney disease (CKD) progression and cardiovascular damage which can be driven by metabolic, hemodynamic, or inflammatory and fibrotic factors.

About FIND-CKD

FIND-CKD (FInerenone, in addition to standard of care, on the progression of kidney disease in patients with Non-Diabetic Chronic Kidney Disease; NCT05047263) is the largest Phase III study to date focused on diverse etiologies of non-diabetic CKD, and the fifth completed Phase III study to report positive results with finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist (nsMRA), which so far was studied in more than 20,000 patients across multiple patient populations with chronic kidney disease and/or heart failure. FIND-CKD was a multicenter, randomized, double-blind, Phase III, placebo-controlled trial that enrolled 1,584 participants with CKD without diabetes across 283 sites, including kidney disease linked to hypertension and glomerular diseases. Participants had an eGFR of 25 to <90 mL/min/1.73 m² and albuminuria (UACR 200 to ≤3500 mg/g) and were on the maximum tolerated dose of a renin-angiotensin system (RAS) inhibitor. Participants were randomized 1:1 to receive finerenone (10 or 20 mg once daily) or matching placebo on top of maximum tolerated labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB).

The primary endpoint of FIND-CKD was the mean annual rate of change in eGFR (total eGFR slope) from baseline to Month 32. Secondary endpoints included a composite of kidney failure, sustained ≥57% eGFR decline, hospitalization for heart failure, or cardiovascular death; a kidney-specific composite of kidney failure or sustained ≥57% eGFR decline; and a cardiovascular-specific composite of hospitalization for heart failure or cardiovascular death.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.

Contact for media inquiries:

Dr. Daniela Esser, phone +49 30 2215-41588

Email: daniela.esser@bayer.com

Find more information at https://pharma.bayer.com/

de (2026-0138e)

Forward-Looking Statements

Bayer AG is a holding company with operating subsidiaries worldwide. References to “Bayer” or “the company” herein may refer to one or more subsidiaries as context requires.