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Investing.com -- Bristol Myers Squibb (NYSE:BMY) stock fell 5.2% in premarket trading Friday after the company announced it would discontinue its Phase 3 Librexia ACS trial for milvexian in acute coronary syndrome patients.
The decision follows a scheduled interim analysis by the Independent Data Monitoring Committee, which determined the trial was unlikely to meet its primary efficacy endpoint. The trial was evaluating milvexian when added to standard care for patients who recently experienced an acute coronary syndrome event.
Bristol Myers Squibb, in collaboration with Johnson & Johnson (NYSE:JNJ), emphasized that no new safety concerns were identified with the investigational therapy. The safety profile remained consistent with previously reported studies of milvexian.
The company’s two other Phase 3 trials in the Librexia program will continue as planned. These include Librexia AF for atrial fibrillation patients and Librexia STROKE for secondary stroke prevention, with topline data expected in 2026.
"Together with Johnson & Johnson, we remain confident in the potential of milvexian to redefine anticoagulant therapy and provide patients and clinicians a new therapeutic option for reducing thrombosis risks without significantly increasing potential bleeding risks," said Roland Chen, MD, senior vice president of drug development at Bristol Myers Squibb.
The company continues to view milvexian as a potential multi-billion-dollar asset that could transform anticoagulant therapy for thrombotic diseases, despite this setback in the acute coronary syndrome indication.
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