Biotech Values

[DewDiligence]

Bayer FXIa inhibitor succeeds_in secondary stroke prevention:

https://www.businesswire.com/news/home/20251123638167/en/Bayers-Asundexian-Met-Primary-Efficacy-and-Safety-Endpoints-in-Landmark-Phase-III-OCEANIC-STROKE-Study-in-Secondary-Stroke-Prevention

Bayer today announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ischemic stroke or high-risk ischemic attack. There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in combination with antiplatelet therapy. Detailed results of OCEANIC-STROKE will be presented at an upcoming scientific congress.

Bayer’s success comes on the heels of BMY/JNJ’s failure in ACS (#msg-176946690), and it is the first phase-3 success for a FXIa inhibitor in any indication.