Bayer AG (OTC:BAYRY) released topline results from the Phase 3 OCEANIC-STROKE study, with its investigational, once daily, oral FXIa inhibitor asundexian.

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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 transient ischemic attack.

A blood clot from a source other than the heart causes a non-cardioembolic ischemic stroke. High-risk transient ischemic attack is a temporary blockage of blood flow to the brain, often called a “mini-stroke.

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There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared ...