Overview
- An independent monitoring committee’s interim analysis found the LIBREXIA-ACS study unlikely to meet its primary efficacy endpoint when milvexian was added to standard antiplatelet therapy after recent acute coronary syndrome.
- The halted trial, designed to enroll about 16,000 patients, assessed whether adding milvexian could reduce cardiovascular death, heart attack, or stroke compared with standard care alone.
- The companies reported no new safety issues, and the safety profile was consistent with earlier milvexian studies, with no detailed efficacy data released.
- Trial monitors recommended that LIBREXIA-AF and LIBREXIA-STROKE proceed, with AF testing milvexian against Eliquis at 100 mg twice daily and stroke prevention using 25 mg twice daily toward 2026 readouts.
- Bristol Myers shares fell roughly 5% in early trading, and analysts cautioned the ACS result could modestly weigh on expectations for the stroke study while having less read-through to the distinct atrial fibrillation setting.