Bayer Secures 5 Global Approvals and Targets Pharma Growth by 2027

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Bayer’s Pharmaceuticals Division secured five global approvals in 2025 and reported Phase III OCEANIC-STROKE success for asundexian’s secondary stroke prevention. The company targets mid-single-digit pharma revenue growth by 2027, 30% operating margin by 2030, and is expanding regulatory filings across cardiovascular, oncology, cardiology, and neurology portfolios.

1. Strong Near-Term Growth Drivers and Financial Targets

During the 44th Annual J.P. Morgan Healthcare Conference, Bayer’s Pharmaceuticals Division outlined a clear path to return to mid-single-digit percentage growth by 2027, supported by five pivotal global approvals in 2025. The division aims to lift its operating margin to approximately 30% by 2030 through a combination of new product launches, organizational delayering and cost efficiencies. Management highlighted that recent launches in oncology and cardiovascular disease have already contributed to a 4% year-on-year increase in core revenues in the first nine months of the fiscal year, setting the stage for sustained top-line momentum.

2. Cardiovascular and Cerebrovascular Innovation Pipeline

Bayer emphasized breakthrough data for asundexian, its oral Factor XIa inhibitor, which met primary safety and efficacy endpoints in the Phase III OCEANIC-STROKE trial for secondary stroke prevention. With approximately 12 million people experiencing stroke annually and up to 30% at risk of recurrence, these results underline the blockbuster potential of asundexian, which has received Fast Track Designation from the FDA. Additionally, finerenone (Kerendia®) has secured expanded FDA and Japan MHLW approvals for heart failure patients with ejection fractions ≥40%, following positive results in the FINEARTS-HF study. Ongoing Phase III programs in heart failure and chronic kidney disease (MOONRAKER and THUNDERBALL) are expected to read out between 2026 and 2028.

3. Oncology Portfolio Momentum

Bayer’s oncology division reported that over 200 000 patients worldwide have been treated with darolutamide (Nubeqa®), which secured a third indication in prostate cancer across the U.S. and Europe in 2025. Global uptake continues to accelerate, with a third approval in China anticipated in 2026. The FDA’s accelerated approval of sevabertinib (Hyrnuo®) for HER2-mutant non-small cell lung cancer, based on SOHO-01 study data, further strengthens the pipeline. Bayer is also advancing next-generation targeted radionuclide therapies, including radium-223 dichloride (Xofigo®), which demonstrated positive results in the EORTC PEACE III combination trial, and multiple first-in-class candidates for KRAS-mutant and MTAP-deleted tumors, all now in Phase I development.

4. Strategic Partnerships and R&D Excellence

Bayer highlighted partnerships as a cornerstone of its R&D strategy, citing collaborations with AskBio for the Phase II gene therapy AB-1002 in congestive heart failure, and with Dewpoint Therapeutics to develop condensate-based treatments for dilated cardiomyopathy. The company also secured exclusive rights in Japan to aficamten, a cardiac myosin inhibitor for hypertrophic cardiomyopathy. Bayer’s commitment to AI-enabled development and precision cardiology, combined with its dynamic operating model, positions the division to bring transformative medicines to patients faster while enhancing long-term shareholder value.

Sources

BRS