BMY Stock Down on Discontinuation of ACS Clinical Study With JNJ

Core Insights - Bristol Myers (BMY) has decided to discontinue the late-stage Librexia study for milvexian, an investigational oral factor XIa inhibitor, due to an interim analysis indicating it is unlikely to meet its primary efficacy endpoint [1][2][3] - Following the announcement, BMY's stock fell by 4%, and year-to-date, shares have decreased by 17.5%, contrasting with the industry growth of 14.9% [1] Group 1: Study Discontinuation - The Librexia ACS study was halted after the Independent Data Monitoring Committee (IDMC) found it unlikely to achieve its primary efficacy goal, which is the time to the first occurrence of stroke and non-CNS systemic embolism [3][6] - Despite the discontinuation, the IDMC did not identify any new safety concerns related to milvexian [3][6] Group 2: Other Clinical Trials - BMY and JNJ will continue with two other late-stage studies: Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention, with top-line data expected in 2026 [4][6] - The IDMC recommended the continuation of these trials, noting they differ from Librexia ACS in patient groups, endpoints, and background therapy [6][7] Group 3: Portfolio Diversification - The discontinuation of the Librexia ACS study is viewed as a setback, but successful development of milvexian for AF and SSP could enhance BMY's cardiovascular portfolio, which includes Camzyos, a cardiac myosin inhibitor [8][9] - BMY is actively seeking to diversify its pipeline, especially as its legacy portfolio faces challenges from generic competition on drugs like Revlimid and Pomalyst [10] Group 4: Recent Acquisitions - BMY announced the acquisition of Orbital Therapeutics for $1.5 billion, which will add OTX-201, a preclinical RNA immunotherapy candidate, to its pipeline [10][11] - This acquisition aims to strengthen BMY's position in the market and expand its therapeutic offerings [11][12]