Bristol Myers Squibb & Co. (NYSE:BMY), in collaboration with Johnson & Johnson (NYSE:JNJ), announced Friday that they decided to stop the Phase 3 Librexia ACS trial evaluating the efficacy and safety of milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent acute coronary syndrome (ACS) event.
- BMY shares are retreating from recent levels. Review the technical setup here
Acute coronary syndrome (ACS) is an umbrella term for situations in which the blood supplied to the heart muscle is suddenly reduced, usually due to a clot.
ACS includes myocardial infarction (MI), also known as a heart attack, and unstable angina, manifesting as sudden, severe chest pain that typically occurs when a person is at rest or with minimal exertion.
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Data
The decision to discontinue the trial follows a preplanned interim analysis by the Independent Data Monitoring Committee (IDMC), which determined the trial is unlikely to meet the primary efficacy endpoint.
No new safety concerns related to the investigational therapy were identified. The safety profile was consistent with previously reported studies of milvexian.
The Librexia clinical trial program includes two other Phase 3 trials, Librexia AF for patients with atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP).
The IDMC recommended these trials continue as planned, with topline data expected in 2026.
Analyst Take
William Blair said that although ACS and secondary stroke prevention are different treatment settings, they stem from similar atherothrombotic biology.
Because both LIBREXIA-ACS and LIBREXIA-STROKE use the same 25 mg twice-daily dose of milvexian, the firm views today's update as a modest negative signal for the LIBREXIA-STROKE study.
Analyst Matt Phipps views the AF indication as being distinct, with the largest market opportunity, and that trial is evaluating a 100 mg BID dose, so it may have less read-through from today's setback.
"We believe near-term focus will continue to be on the upcoming ADEPT-2 readout of Cobenfy in Alzheimer's disease psychosis, particularly given the difficult year for Bristol Myers with multiple late-stage trial setbacks," analyst Phipps wrote on Friday.
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- The Phase 3 RELATIVITY-098 trial of Opdualag (nivolumab and relatlimab-rmbw) for the adjuvant treatment of completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival.
BMY Price Action: Bristol-Myers Squibb shares were down 3.59% at $46.88 at the time of publication on Friday, according to Benzinga Pro data.
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