Overview
- The registrational trial met primary efficacy and safety goals, with a 50 mg daily dose reducing ischemic stroke versus placebo without increasing ISTH-defined major bleeding.
- Asundexian was tested alongside antiplatelet therapy in patients with a prior ischemic stroke, according to Bayer’s topline release.
- The U.S. FDA has granted Fast-Track status to the program for potential stroke prevention.
- Bayer will begin global discussions on approval filings, while full results remain unpublished until the planned congress presentation.
- Shares jumped roughly 11–12% as analysts flagged blockbuster potential, with JPMorgan citing >€1 billion in annual sales and Goldman Sachs estimating up to €3 billion; the news follows a 2023 failure in atrial fibrillation and comes as rivals like BMS’s milvexian face setbacks.