FDA has approved Bayer’s asundexian (marketed as Sunharbo) to reduce recurrence of ischemic stroke in adults who recently had a mild-to-moderate non-cardioembolic ischemic stroke or a high-risk transient ischemic attack, according to the agency’s decision coverage. The approval positions asundexian as a Factor XIa inhibitor in a new mechanistic class aimed at lowering clot formation risk. In the underlying Phase 3 program cited in the coverage, Sunharbo reduced secondary stroke risk versus placebo, while major bleeding rates were similar between groups. The most commonly reported adverse reaction was diarrhea. Bayer said uptake could depend on early specialist involvement, given that stroke neurologists are central to initial management. For biotech and pharma, the move underscores continuing regulatory interest in anticoagulation approaches designed to preserve hemostasis better than existing options. It also sets a competitive benchmark for next-wave secondary prevention drugs targeting thrombin generation pathways with a narrower bleeding profile.