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Bayer Wins US FDA Approval for Sunharbo to Reduce Risk of Secondary Stroke in Adults

MT Newswires·11/09/2026 23:15:56
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11:15 PM EST, 11/09/2026 (MT Newswires) -- Bayer (BAYN.F) secured the US Food and Drug Administration's approval for Sunharbo, combined with antiplatelet therapy, to reduce the risk of secondary stroke among certain adults. The Germany-listed life science company said Tuesday the drug, also known as asundexian, is indicated for adults who recently had non-cardioembolic ischemic stroke or high-risk transient ischemic attack. The decision was based on the positive results of the global phase 3 Oceanic-Stroke trial. Previously, Bayer received approval for asundexian in China and is awaiting decisions for similar applications in other markets worldwide.