On April 1, 2025, during Bayer's Pharmaceuticals Division 2025 Global Media Day, the company showcased significant advancements in its growth strategy and R&D pipeline for its pharmaceuticals division. The company is expanding its cardiology portfolio with the launch of Beyonttra® for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM) and plans to introduce finerenone (Kerendia®) by the end of the year for the treatment of common heart failure, specifically heart failure with a left ventricular ejection fraction (LVEF) ≥40%. Additionally, elinzanetant, a non-hormonal therapy for moderate to severe vasomotor symptoms in menopausal women, is expected to be launched for the first time by late summer 2025. In oncology, darolutamide (Nubeqa®), a key growth driver, is anticipated to receive U.S. approval for its third indication in 2025, allowing darolutamide to be used in combination with androgen deprivation therapy (ADT) for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC).

"2025 is a milestone year for Bayer's pharmaceuticals division, with several significant product launches anticipated. The company is fully committed to advancing its R&D pipeline," said Stefan Oelrich, Member of the Board of Management of Bayer AG and President of Bayer’s Pharmaceuticals Division. "Our growth strategy is on track and delivering tremendous value. This year, we will be launching several breakthrough products with blockbuster potential into the market."

Six Products with Blockbuster Drug Potential

Nubeqa® (Darolutamide)

Bayer Plans to Launch the Third Indication of Nubeqa® in 2025, Supported by Strong Data from the ARANOTE Trial, Which Investigated the Efficacy and Safety of Darolutamide Plus ADT Versus Placebo Plus ADT in Patients with mHSPC. Nubeqa® Is Already Approved for Use in Combination with ADT and Docetaxel for the Treatment of mHSPC. Additionally, It Is Also Approved for Use in Combination with ADT for Adult Patients with Non-Metastatic Castration-Resistant Prostate Cancer (nmCRPC) at High Risk of Metastasis.

Kerendia® (Finerenone)

In the FINEARTS-HF Phase III clinical study, finerenone demonstrated a statistically significant improvement in cardiovascular outcomes in heart failure patients (LVEF ≥40%). Based on this positive data, Bayer has submitted marketing applications for this indication in the United States, the European Union, China, and Japan. Finerenone is the only drug targeting the mineralocorticoid receptor (MR) pathway that has shown cardiovascular benefits in Phase III studies for heart failure patients with LVEF≥40%. Finerenone has already been approved for the treatment of adult patients with chronic kidney disease (CKD) associated with type 2 diabetes.

Beyonttra® (acoramidis)

In February this year, the European Commission approved the marketing authorization of acoramidis (trade name: Beyonttra®) for the treatment of adult patients with cardiomyopathy suffering from wild-type or variant transthyretin amyloidosis (ATTR-CM). ATTR-CM is a progressive and fatal disease that leads to heart failure through infiltrative, restrictive cardiomyopathy. Due to the continuous deposition of amyloid substances in the heart, patients face the risk of ongoing disease progression. Beyonttra® is a highly selective small molecule, orally administered, near-complete (≥90%) transthyretin protein (TTR) stabilizer. The drug has been successfully launched in Europe, with Germany being the first country of availability.

Elinzanetant

In three Phase III clinical trials (OASIS-1, 2, 3), elinzanetant has successfully demonstrated its efficacy and safety in reducing moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause. In January this year, the Phase III OASIS 4 clinical trial achieved positive results, meeting its primary endpoint and demonstrating the efficacy of elinzanetant in treating moderate to severe VMS in women receiving adjuvant endocrine therapy for breast cancer or at higher risk of breast cancer. In all four Phase III clinical trials, participants also showed improvements in sleep disturbances and menopause-related quality of life. Elinzanetant is currently being submitted for marketing authorization in multiple markets worldwide, with Bayer expecting approvals in the United States and Europe this year.

Eylea® 8mg (Aflibercept 8mg)

In the field of ophthalmic treatment, Eylea® 8mg, with its longer treatment intervals, is expected to become the new standard therapy for its already approved indications—neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). In December 2024, the global Phase III QUASAR study demonstrated that for patients with retinal vein occlusion (RVO), including central, branch, and hemi-retinal vein occlusion, with secondary macular edema, aflibercept 8mg achieved comparable efficacy in vision improvement while allowing for a reduced dosing frequency compared to the current standard treatment (Eylea® 2mg monthly). Detailed results will be submitted to multiple health regulatory agencies worldwide.

Asundexian

Asundexian is a selective oral FXIa inhibitor, currently under investigation as a potential novel antithrombotic therapy for the prevention of recurrent ischemic stroke in patients receiving standard antiplatelet therapy. The hypothesized mechanism of FXIa inhibition aims to decouple stroke prevention from bleeding risk. The Phase III OCEANIC-STROKE clinical trial is progressing smoothly, studying stroke prevention in patients receiving standard antiplatelet therapy following non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The study is expected to be completed later this year. This indication previously received Fast Track designation from the U.S. Food and Drug Administration (FDA).

New Contrast Agents for Imaging Diagnostics

Bayer's Imaging Diagnostics Business Offers a Comprehensive Portfolio of Contrast Agents and Significantly Advances Its Magnetic Resonance Imaging (MRI) Innovation Pipeline. The Phase III Clinical Study QUANTI Explored the Broad Potential Indications of the Gadolinium-Based MRI Contrast Agent Gadoquatrane in Pediatric and Adult Patients, Successfully Achieving Both Primary and All Key Secondary Endpoints. Compared to the Control Group Administered a Dose of 0.1 mmol Gd/kg Body Weight, Gadoquatrane Reduced the Gadolinium Dose by 60%. Reducing the Gadolinium Dose is Particularly Important for Patients Requiring Repeat Contrast-Enhanced MRI Examinations and Vulnerable Populations Such as Pediatrics. Bayer Plans to Submit Marketing Applications to Multiple Health Regulatory Agencies Worldwide.

Cell Therapy and Gene Therapy for Parkinson's Disease Take the Lead

Bayer’s Cell and Gene Therapy Platform Achieves Key Progress, Reaching Important Clinical Trial Milestones, Particularly in the Field of Parkinson's Disease.

Bemdaneprocel is an investigational cell therapy that involves surgically implanting dopamine-producing neural precursor cells into the brain. Based on positive data from the Phase I clinical trial exPDite, it will directly advance to Phase III clinical trials for Parkinson's disease. The U.S. Food and Drug Administration (FDA) has granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation, recognizing its innovative potential in treating Parkinson's disease.

AB-1005 is an investigational gene therapy for the treatment of Parkinson's disease, currently in Phase II clinical trials. The REGENERATE-PD clinical trial has now enrolled randomized participants. AB-1005 is based on adeno-associated virus (AAV) and delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to the brain, with the potential to restore the function of dopamine-producing neurons. Based on preliminary clinical evidence, the U.S. FDA has granted AB-1005 Regenerative Medicine Advanced Therapy (RMAT) designation due to its potential to slow disease progression and improve motor outcomes in patients with moderate Parkinson's disease. Additionally, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded AB-1005 the Innovative Licensing and Access Pathway (ILAP) designation. These two designations from the U.S. and UK highlight the potential of AB-1005 to address a significant unmet global medical need in the field of Parkinson’s disease.

As part of its transformation, Bayer is focusing on key R&D areas and has established a highly differentiated R&D pipeline for long-term growth in oncology, cardiovascular and kidney diseases, neurology and rare diseases, and immunology. Through rigorous evaluation and prioritization, Bayer's pharmaceuticals division is now fully committed to areas with the greatest unmet needs and the highest value potential.

Advance Precision Oncology Development

In the field of precision oncology, the oral small molecule tyrosine kinase inhibitor (investigational drug BAY 2927088) represents a potential new targeted therapy for patients with non-small cell lung cancer (NSCLC) harboring HER2 activating mutations. In the ongoing SOHO-01 Phase I/II clinical trial evaluating its safety and efficacy, the drug has shown promising results as a second-line treatment, earning Breakthrough Therapy Designation from both the U.S. FDA and China's Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA). Additionally, BAY 2927088 is being evaluated for its potential as a first-line treatment in the SOHO-02 Phase III clinical trial, targeting patients with advanced NSCLC whose tumors have HER2 activating mutations. The efficacy and safety of BAY 2927088 are also being studied in the global panSOHO Phase II clinical trial for adult patients with metastatic or unresectable solid tumors carrying HER2 activating mutations. Recently, a Phase I clinical trial was initiated in patients with advanced KRAS-mutant tumors to investigate BAY 3498264, an orally available, selective SOS1 inhibitor.

Targeted Radionuclide Therapy (TRT) is a strategic focus area for Bayer's precision oncology drug development. **Dofego®** is the first and only targeted alpha therapy for patients with metastatic castration-resistant prostate cancer. Building on over a decade of real-world experience with Dofego®, Bayer’s evolving TRT portfolio includes new targeted approaches that combine alpha radionuclides, such as actinium-225, with different targeting moieties, including antibodies, small molecules, or peptide-based molecules. As targeted PSMA (prostate-specific membrane antigen) candidates, 225Ac-pelgifatamab (BAY 3546828) and 225Ac-PSMA-Trillium (BAY 3563254) are currently in Phase I clinical trials in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).

In recent years, targeted investments in R&D and platform companies have strengthened Bayer's early- and late-stage R&D pipelines. With the acquisition of Tavros Therapeutics by Vividion, Bayer continues to leverage its chemoproteomics technology platform to unlock traditionally difficult-to-drug targets through precise small-molecule therapies. Bayer has initiated Phase I clinical trials for an oral KEAP1 activator in solid tumors and for an oral STAT3 inhibitor in solid tumors and hematologic malignancies. Additionally, it has IND-enabling programs, including the RAS-PIK3CA program targeting RAS-driven cancers.

Strengthen the Cardiovascular R&D Pipeline

In the field of cardiovascular diseases, Bayer is advancing therapeutic drugs in Phase II clinical trials. BAY 3283142, a soluble guanylate cyclase (sGC) activator for patients with chronic kidney disease (CKD), has entered Phase II clinical trials. By regulating sGC through a heme-independent pathway, this investigational sGC activator represents a new class of drugs that may offer advantages under conditions of high oxidative stress, such as diabetic nephropathy.

Through the anti-α2-antiplasmin antibody program, Bayer is developing a thrombolytic agent based on a new model and mechanism of action. This antibody specifically blocks the endogenous plasmin inhibitor α2AP, dissolving acute embolisms or thrombi without increasing the risk of bleeding. Currently, this investigational antibody is undergoing Phase II clinical trial evaluation in patients with deep vein thrombosis and has the potential to become a treatment option for indications with high medical relevance.

AB-1002 Gene Therapy is Currently Undergoing an International Phase II Clinical Trial to Evaluate its Efficacy in Treating Congestive Heart Failure (CHF), Involving Adults with Non-Ischemic Cardiomyopathy and New York Heart Association (NYHA) Class III Heart Failure Symptoms with Reduced Ejection Fraction.