{"id":65777,"date":"2026-05-20T12:29:45","date_gmt":"2026-05-20T04:29:45","guid":{"rendered":"https:\/\/flcube.com\/?p=65777"},"modified":"2026-05-20T12:29:45","modified_gmt":"2026-05-20T04:29:45","slug":"bayers-asundexian-receives-fda-priority-review-for-secondary-stroke-prevention-following-positive-phase-iii-oceanic-stroke-trial","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=65777","title":{"rendered":"Bayer’s Asundexian Receives FDA Priority Review for Secondary Stroke Prevention Following Positive Phase III OCEANIC-STROKE Trial"},"content":{"rendered":"\n

Bayer AG<\/strong> (ETR: BAYN<\/a>) announced today that the U.S. Food and Drug Administration (FDA)<\/strong> has accepted the company’s New Drug Application (NDA)<\/strong> and granted Priority Review designation<\/strong> for its investigational oral Factor XIa (FXIa) inhibitor, asundexian<\/strong>, for the prevention of secondary stroke<\/strong> in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA)<\/strong>. The NDA is supported by positive results from the Phase III OCEANIC-STROKE trial<\/strong>.<\/p>\n\n\n\n

Regulatory Milestone<\/h2>\n\n\n\n
Parameter<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>U.S. FDA<\/td><\/tr>
Application Type<\/strong><\/td>New Drug Application (NDA)<\/td><\/tr>
Review Designation<\/strong><\/td>Priority Review<\/td><\/tr>
Previous Designation<\/strong><\/td>Fast Track (granted 2023)<\/td><\/tr>
Indication<\/strong><\/td>Secondary stroke prevention in non-cardioembolic ischemic stroke\/TIA patients<\/td><\/tr>
PDUFA Date<\/strong><\/td>Expected Q4 2026 (6-month review timeline)<\/td><\/tr>
Company<\/strong><\/td>Bayer AG (ETR: BAYN)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Trial Results \u2013 OCEANIC-STROKE Phase III<\/h2>\n\n\n\n
Endpoint<\/th>Outcome<\/th>Significance<\/th><\/tr><\/thead>
Primary Efficacy<\/strong><\/td>Time to first occurrence of ischemic stroke<\/td>Met<\/td><\/tr>
Primary Safety<\/strong><\/td>Time to ISTH major bleeding<\/td>Met<\/td><\/tr>
Trial Design<\/strong><\/td>Randomized, double-blind, placebo-controlled<\/td>Global study<\/td><\/tr>
Patient Population<\/strong><\/td>Non-cardioembolic ischemic stroke or TIA survivors<\/td>High-risk secondary prevention cohort<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

The dual success in both efficacy and safety endpoints represents a significant achievement in anticoagulation development, where balancing stroke prevention against bleeding risk has historically been challenging.<\/p>\n\n\n\n

Drug Profile & Mechanism of Action<\/h2>\n\n\n\n