Bayer (BAYRY) announced that the FDA has accepted the company’s new drug application and granted priority review designation for its investigational oral Factor XIa inhibitor, asundexian, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack. The NDA is based on results from the Phase III OCEANIC-STROKE trial. The study results were presented at the International Stroke Conference 2026 in New Orleans and published in The New England Journal of Medicine.
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