Overview
- In OCEANIC-STROKE, asundexian 50 mg once daily plus antiplatelet therapy significantly lowered ischemic stroke risk versus placebo in patients after a non-cardioembolic ischemic stroke or high-risk TIA.
- The trial met its primary safety endpoint with no increase in ISTH major bleeding compared with placebo.
- The study was international, randomized, double-blind, placebo-controlled, event-driven, and enrolled more than 12,300 participants.
- Bayer said it will engage health authorities worldwide to prepare marketing authorization applications, with full data to be presented at an upcoming scientific congress.
- Bayer shares rose more than 8% after the announcement, reversing sentiment following a 2023 failure in an atrial fibrillation study.