Overview
- Bayer reported that 50 mg once-daily asundexian plus antiplatelet therapy significantly reduced ischemic stroke versus placebo in the Phase III OCEANIC-STROKE study.
- The trial met primary efficacy and safety endpoints with no increase in ISTH major bleeding compared with placebo.
- OCEANIC-STROKE was an event-driven, randomized, double-blind, placebo-controlled study enrolling more than 12,300 patients after non-cardioembolic ischemic stroke or high-risk TIA.
- The company said it will engage health authorities to prepare marketing authorization submissions and will present detailed results at an upcoming scientific congress.
- Shares rose more than 8% after the announcement, reversing sentiment following a 2023 failure in an atrial fibrillation trial.