Bayer announced that its oral Factor XIa inhibitor asundexian met the primary endpoint in the Oceanic Stroke Phase III trial, reducing recurrent ischemic stroke risk when added to standard antiplatelet therapy. The company said the therapy cut ischemic stroke versus placebo without increasing major bleeding events in a study of over 12,000 patients; full data will be presented at a forthcoming medical meeting. The result marks the first Phase III success for the FXIa class after a string of late-stage setbacks and bolsters competing programs from Bristol Myers Squibb/Janssen (milvexian) and Novartis (abelacimab). Bayer’s shares jumped on the readout as investors reprice the commercial potential for a potentially safer anticoagulation option in secondary stroke prevention. Regulators will want to review detailed safety-by-subgroup and bleeding definitions before clearance discussions begin.