Bayer AG is making significant strides in its pharmaceutical growth strategy, with multiple regulatory filings underway and key clinical milestones achieved across its pipeline. The company is focusing on oncology, cardiology, neurology, and immunology to address unmet medical needs. These advancements were announced on the occasion of the 43rd J.P. Morgan Healthcare Conference in San Francisco.
Prostate Cancer
Bayer is strengthening its position in prostate cancer with a planned launch of a third indication for darolutamide (NUBEQA®) in 2025. The application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has been submitted for this third indication for darolutamide in addition to filings in the U.S. and the EU earlier in 2024. This oral androgen receptor inhibitor, supported by data from the ARANOTE trial, has shown positive results with and without chemotherapy in metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA achieved blockbuster status in September 2024, surpassing one billion euros in annual sales and is the fastest-growing androgen receptor inhibitor in the U.S.
Cardiovascular
In cardiovascular health, Bayer has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) and CDE of China’s NMPA for finerenone (KERENDIA®) to treat heart failure (HF) patients with a left ventricular ejection fraction (LVEF) of ≥40%. This submission is based on the Phase III FINEARTS-HF trial, which demonstrated a 16% reduction in the composite of cardiovascular death and total heart failure events compared to placebo. Regulatory filings are planned, with a potential market launch by the end of 2025.
Women's Healthcare
Elinzanetant, an investigational compound, achieved a clinical milestone in early 2025 with positive Phase III readouts. The OASIS 4 study evaluated elinzanetant as a non-hormonal treatment for moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. The study met its primary endpoints, showing statistically significant reductions in the frequency of moderate to severe VMS from baseline to weeks 4 and 12 compared to placebo. It also achieved all secondary endpoints, demonstrating reductions in VMS severity at weeks 4 and 12 and maintaining effects over the study period. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late-stage clinical development for non-hormonal treatment of VMS associated with menopause.
Radiology
Bayer's radiology pipeline is progressing with the Phase III QUANTI clinical development program, which evaluated the investigational compound gadoquatrane. The first data showed that gadoquatrane successfully achieved its primary endpoint, highlighting its potential as a low-dose contrast agent option.
Parkinson's Disease
Bemdaneprocel, a stem cell-based therapy for Parkinson’s disease, will advance directly to Phase III clinical development based on positive data from the Phase I exPDite trial. This therapy involves surgically implanting dopamine-generating nerve cell precursors into the brain. The FDA granted bemdaneprocel Regenerative Medicine Advanced Therapy (RMAT) designation. Additionally, AB-1005, an investigational AAV-based gene therapy, is advancing in Phase II with the REGENERATE-PD clinical trial. AB-1005 delivers the human glial cell line-derived neurotrophic factor (GDNF) transgene to protect and restore dopamine-generating neurons. It has received U.S. FDA Fast Track and UK Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Passport designations.
Precision Oncology
Bayer is strengthening its early and late pipelines through targeted investments in R&D and platform companies. Vividion’s acquisition of Tavros Therapeutics enhances Bayer’s chemoproteomics platform technology for undruggable targets. Phase I trials have begun with an oral KEAP1 activator in solid tumors and an oral STAT3 inhibitor in solid and hematologic malignancies. Additionally, BAY 2927088, an oral tyrosine kinase inhibitor for non-small cell lung cancer (NSCLC) with HER2 activating mutations, has shown promising results in the Phase I/II SOHO-01 study and has Breakthrough Therapy Designations from the FDA and Chinese CDE. A Phase I clinical trial with BAY3498264, an oral selective Son of Sevenless Homologue 1 (SOS1) inhibitor, has been initiated for patients with KRAS G12C-mutated metastatic cancer.
Targeted Radionuclide Therapy
Bayer's Targeted Radionuclide Therapy (TRT) portfolio includes novel approaches combining alpha radionuclides with targeting moieties. 225Ac-pelgifatamab (BAY 3546828) and 225Ac-PSMA-Trillium (BAY 3563254), targeting PSMA, are in Phase I clinical trials for advanced metastatic castration-resistant prostate cancer (mCRPC).
Other Developments
BAY3283142, a soluble guanylate cyclase (sGC) activator, has entered a Phase II clinical study for chronic kidney disease (CKD). An anti-alpha2 antiplasmin antibody program is in Phase II for deep vein thrombosis, representing a new thrombolytic agent modality.
