Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application and granted Priority Review for asundexian, an investigational oral Factor XIa inhibitor for preventing secondary stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack.
The pharmaceutical giant, with a market capitalization of $43.3 billion, has seen its stock surge 65.6% over the past year as investors anticipate growth from its drug pipeline.
The submission is based on results from the Phase III OCEANIC-STROKE trial, which met its primary efficacy and safety outcomes. The study results were presented at the International Stroke Conference 2026 in New Orleans and published in The New England Journal of Medicine.
Priority Review is an FDA designation for medicines that, if approved, would provide a significant improvement in safety or effectiveness for a serious condition. In 2023, asundexian received Fast Track Designation from the FDA.
Stroke is the fifth leading cause of death in the U.S. Approximately 795,000 people experience a stroke each year, with about 87% being ischemic and 23% recurrent.
