(RTTNews) - Bayer AG (BAYRY) announced that the U.S. FDA has accepted its NDA and granted Priority Review for Asundexian, an investigational oral Factor Xla (FXla) inhibitor, for the prevention of secondary stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA).
The submission is supported by positive results from the pivotal Phase 3 OCEANIC-STROKE trial, which met both its primary efficacy and endpoint (time to first ischemic stroke) and its primary safety endpoint (time to ISTH major bleeding). Results were presented at the International Stroke Conference 2026 and published in the New England Journal of Medicine.
"Secondary stroke remains a serious and persistent challenge, and the FDA's Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention," said Yesmean Wahdan, M.D., Senior Vice President, U.S. Medical Affairs, Bayer. "We are proud of this important milestone that builds on our long-standing commitment to innovation in anti-thrombotic therapies and look forward to collaborating with the FDA as we work to bring Asundexian to patients in need."
Asundexian previously received Fast Track designation in 2023. Priority Review is reserved for therapies that could represent significant improvements in safety or effectiveness for serious conditions.
Stroke remains the fifth leading cause of death in the U.S., with approximately 795,000 cases annually, of which 87% are ischemic and nearly one-quarter are recurrent. About one in five survivors will experience another stroke within five years.
FXla, as the target of Asundexian, plays a minor role in normal clotting but is believed to contribute to harmful thrombus formation and vessel blockage, making it a promising pathway for safer anticoagulation.
BAYRY has traded between $6.55 and $14.85 over the past year. The stock closed Monday's trading at $11.02, up 1.10%.
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