Bayer reported that its oral Factor XIa inhibitor asundexian met the primary endpoint in a pivotal phase III stroke prevention trial, reducing recurrent ischemic stroke without a reported increase in major bleeding. The Oceanic Stroke study enrolled over 12,000 patients and compared asundexian plus standard antiplatelet therapy to placebo plus antiplatelet therapy. The outcome delivers a rare late‑stage win for FXIa inhibitors, a class aimed at decoupling antithrombotic efficacy from bleeding risk. Bayer will present full data at a scientific meeting and begin regulatory discussions; competitors with FXIa programs will accelerate readouts and filings. Analysts saw the result as validation for FXIa as a clinically actionable target.