Overview
- An independent monitoring committee’s preplanned interim analysis found the trial unlikely to meet its primary efficacy goal when milvexian was added to standard antiplatelet therapy.
- No new safety concerns were identified, with a safety profile consistent with prior studies.
- The halted LIBREXIA-ACS study was designed to enroll about 16,000 patients to track reductions in heart attack, stroke, or cardiovascular death.
- Late-stage milvexian trials in atrial fibrillation and secondary stroke prevention continue on the committee’s recommendation, with topline results expected in 2026.
- Bristol Myers shares fell about 5% in premarket trading as analysts framed the outcome as a setback for Factor XIa inhibitors and for the company’s late-stage pipeline.