Asundexian Phase III Success Garners FDA Fast Track; Hyrnuo and Kerendia Gain Key Approvals

BAYRYBAYRY

Bayer’s Phase III OCEANIC-STROKE trial of asundexian met primary endpoints, positioning the Factor XIa inhibitor for blockbuster potential with FDA fast track designation in secondary stroke prevention. Hyrnuo (sevabertinib) received FDA accelerated approval for HER2-mutant NSCLC, and Kerendia (finerenone) was approved for heart failure with LVEF ≥40%.

1. Strategic Growth Targets and Financial Outlook

At the 44th Annual J.P. Morgan Healthcare Conference, Bayer Aktiengesellschaft’s Pharmaceuticals Division outlined a clear financial roadmap: return to mid-single-digit percentage revenue growth by 2027 and achieve an operating margin of approximately 30% by 2030. In 2025 the division recorded five pivotal global drug approvals, underscoring its execution strength. Management highlighted that revenue from newly launched products grew by over 20% year-on-year, while R&D intensity remains above 16% of sales. Cost-reduction measures and organizational delayering are expected to deliver savings of €1.5 billion by 2026, supporting reinvestment in high-value pipeline assets and commercial expansion in key markets including the United States, EU and Japan.

2. Cardiovascular and Cerebrovascular Pipeline Advances

Bayer emphasized landmark Phase III data for asundexian, a once-daily oral Factor XIa inhibitor for secondary stroke prevention: the OCEANIC-STROKE trial met both safety and efficacy endpoints, positioning the drug for blockbuster potential in a market where 20–30% of the 12 million annual stroke survivors face recurrence. Asundexian has received Fast Track designation from the U.S. FDA. Separately, finerenone (Kerendia®) secured FDA and Japanese MHLW approvals for heart failure patients with left ventricular ejection fraction ≥40%, building on its established chronic kidney disease indication. Ongoing Phase III programs MOONRAKER and THUNDERBALL are evaluating finerenone across broader cardio-renal indications, with topline results expected in mid-2026. The division also reported Phase II progress on AB-1002, a single-dose gene therapy for congestive heart failure, and initiation of Phase II and Phase I studies for a DVT-targeted antibody (BAY-3018250) and a GIRK4 inhibitor (BAY-3670549), respectively.

3. Oncology Portfolio Momentum and Precision Pipeline

Bayer’s oncology business continues to scale globally, driven by Nubeqa® (darolutamide) which has treated over 200,000 prostate cancer patients worldwide and is on track for a third regulatory approval in China in 2026. Hyrnuo® (sevabertinib) received accelerated approval from the FDA for HER2-mutant non-small cell lung cancer and holds Breakthrough Therapy Designations in both the U.S. and China. The EORTC PEACE III study of radium-223 dichloride (Xofigo®) in combination with enzalutamide met its primary endpoint, and an additional Phase III radium-223 trial will conclude in 2026 to inform future filings. Bayer’s early-stage oncology pipeline includes KRAS-mutant inhibitors, next-generation targeted radionuclide therapies for hepatocellular carcinoma, and a PRMT5 inhibitor for MTAP-deleted tumors, all advancing through Phase I, reinforcing its commitment to precision oncology.

Sources

BRS