Bayer announced positive top‑line Phase III results for its oral Factor XIa inhibitor asundexian, meeting the primary endpoint in a secondary stroke prevention study and demonstrating reduced recurrent ischemic stroke without a significant uptick in major bleeding. The readout, from the Oceanic Stroke program, provides the first definitive late‑stage success for the FXIa class in stroke. Company statements and preliminary reports emphasize an ischemic risk reduction and a bleeding profile comparable to placebo when added to standard antiplatelet therapy. Bayer plans to present detailed data at an upcoming medical congress and engage regulators on approval pathways. The result re‑energizes interest across developers of FXIa inhibitors and may reshape anticoagulation strategies if detailed subgroup and safety data confirm broad applicability.