Bayer secures five pivotal 2025 approvals; asundexian shows Phase III stroke success

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Bayer announced five pivotal global drug approvals in 2025 and highlighted Phase III success for Factor XIa inhibitor asundexian in secondary stroke prevention with FDA Fast Track status. The company also expanded finerenone heart failure indications, gained European approval for acoramidis, and saw Nubeqa patient numbers exceed 200,000.

1. Bayer and Orion Project Strong Growth for Darolutamide

Bayer’s oncology arm received a significant boost as partner Orion Corporation updated its projections for darolutamide (marketed as Nubeqa®), the co-developed prescription therapy for prostate cancer. Orion, which manufactures tablets for Bayer and collects royalties on sales, announced that Nubeqa has already become its largest product, generating net sales of EUR 400 million in 2025 alone. Based on joint scenario planning, Orion now estimates that its share of annual net sales could exceed EUR 1 billion by the end of the decade. The timing remains subject to regulatory approvals across additional indications and further market penetration in the U.S., Europe and Asia-Pacific regions, but the consensus forecast among both companies points to sustained double-digit growth rates through 2030.

2. Strategic Update at 44th J.P. Morgan Healthcare Conference

At the J.P. Morgan Healthcare Conference in January, Bayer’s Pharmaceuticals Division head Stefan Oelrich outlined a roadmap targeting a return to mid-single-digit percentage growth by 2027 and operating margins near 30% by 2030. He highlighted five worldwide approvals achieved in 2025, including expansions in women’s health and cardiology, and emphasized organizational delayering initiatives projected to deliver cost savings of EUR 500 million by 2028. Oelrich also pointed to the acceleration of digital and AI-enabled R&D processes, which reduced average phase-III cycle times by 15% compared to 2023.

3. Oncology and Cardiovascular Pipeline Advances

Bayer’s pipeline momentum extends beyond Nubeqa. In cardiovascular medicine, asundexian (an oral Factor XIa inhibitor) met primary endpoints in the Phase III OCEANIC-STROKE study and holds FDA Fast Track designation for secondary stroke prevention, addressing a global recurrent stroke risk affecting some 12 million patients annually. In oncology, Hyrnuo® (sevabertinib) received accelerated FDA approval for HER2-mutant non-small cell lung cancer after demonstrating a 60% objective response rate in early cohorts. Additional pivotal readouts are expected for two more Phase III prostate cancer trials in 2027 and 2028. Bayer’s strategic focus on modality-rich innovation—from gene therapies in heart failure to targeted radionuclide therapies in mCRPC—positions the company for sustained growth over the next five years.

Sources

BRWSG