Bristol Myers Squibb (NYSE:BMY) dropped 5.2% in premarket trading on Friday after the pharmaceutical company said it would stop its Phase 3 Librexia ACS study of milvexian in patients with acute coronary syndrome.
The move comes after a planned interim review by the Independent Data Monitoring Committee, which concluded the study was unlikely to achieve its primary efficacy goal. The trial was assessing whether adding milvexian to standard therapy could benefit patients who had recently suffered an acute coronary syndrome event.
The company, which is co-developing the drug with Johnson & Johnson (NYSE:JNJ), stressed that the decision was not tied to any new safety issues. The therapy’s safety profile remained in line with earlier clinical findings.
Bristol Myers confirmed that the other two late-stage studies in the Librexia program will proceed. These include Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention, with initial data expected in 2026.
Roland Chen, MD, senior vice president of drug development at Bristol Myers Squibb, said, “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.”
Despite the discontinuation of the ACS trial, the company still views milvexian as a major commercial opportunity, projecting that the drug could become a multi-billion-dollar therapy for thrombotic conditions.