Further steps forward in Bayer’s asundexian development

19 May 2026

The US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare have accepted New Drug Applications (NDA) for the investigational Factor XIa (FXIa) inhibitor, asundexian, for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). 

Priority Review designation has also been granted to the Bayer (BAYN: DE) drug by the FDA.

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