BAYRY News & Events

Morgan Stanley analyst Terence Flynn notes that Bayer (BAYRY) reported positive top line data from a Phase 3 trial of pipeline FXIa inhibitor asundexian for secondary stroke prevention, which met its primary efficacy and safety endpoints. This is the first positive Phase 3 trial of a FXIa inhibitor and could "somewhat renew investor optimism for the category," including Bristol Myers' (BMY) and Johnson & Johnson's (JNJ) milvexian, which is also in Phase 3 development for SSP and atrial fibrillation, the analyst tells investors. The firm maintains an Underweight rating on Bristol shares, which are up $1.86, or 4%, to $48.11 in early trading.

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Bayer 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.