Bayer reported that asundexian, an oral factor XIa inhibitor, met its primary endpoint in a Phase III study, reducing recurrent ischemic stroke without increasing major bleeding, the company said in a topline announcement. The Oceanic Stroke trial enrolled over 12,000 patients and compared asundexian plus standard antiplatelet therapy to placebo plus antiplatelet therapy. Topline results showed a statistically significant reduction in ischemic stroke recurrence and no signal for excess major bleeding. Bayer plans to present detailed data at an upcoming scientific meeting and will discuss next steps with regulators as it evaluates potential approval pathways. The win provides a major validation for the FXIa mechanism after several high-profile setbacks in the class and could reenergize investment and development in safer anticoagulation strategies.