Bayer announced that asundexian, its oral factor XIa (FXIa) inhibitor, met the primary endpoint in a large Phase III secondary prevention trial, reducing recurrent ischemic stroke without increasing major bleeding. The Oceanic Stroke study enrolled over 12,000 patients and tested asundexian added to standard antiplatelet therapy versus placebo. Bayer said detailed efficacy and safety data will be disclosed at an upcoming scientific meeting. The success revives momentum for the FXIa inhibitor class after prior setbacks and lifts prospects for a new anticoagulant mechanism that aims to uncouple thrombosis prevention from bleeding risk. Analysts and competitors will scrutinize subgroup and safety datasets; Bayer’s shares jumped on the announcement, and rival programs from Bristol Myers Squibb/Janssen and Novartis now face heightened expectations for their late-stage readouts.