Johnson & Johnson and Bristol Myers Squibb announced that they are discontinuing the Librexia ACS Phase 3 trial of milvexian, a factor XIa inhibitor designed to reduce clot formation in acute coronary syndrome patients. The decision follows an independent review that found the study unlikely to meet its primary efficacy endpoint, citing futility and safety concerns that outweighed potential benefits.
Milvexian had been fast‑tracked by the FDA for three indications—acute coronary syndrome, atrial fibrillation, and secondary stroke prevention—after early data suggested a lower bleeding risk compared with existing anticoagulants. The ACS trial, which enrolled more than 5,000 patients across 200 sites, was expected to be the first to demonstrate clinical benefit and could have positioned milvexian as a multibillion‑dollar asset. The halt therefore removes a key revenue driver from both companies’ future pipeline projections.
The companies will continue with two other Phase 3 studies: Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention. Results from these trials are anticipated in 2026, and management remains optimistic about their potential, citing robust Phase 2 data. However, the ACS setback has already weighed on investor sentiment, with Bristol Myers Squibb’s market value declining in pre‑market trading and Johnson Heath’s shares remaining flat or slipping slightly.
Management emphasized that the decision was driven by a rigorous assessment of efficacy and safety data. Roland Chen, Senior Vice President of Drug Development at Bristol Myers Squibb, stated, “We remain confident in milvexian’s potential to redefine anticoagulant therapy, but the data from the ACS trial do not support continuation.” He added that the company’s confidence in the AF and STROKE indications remains high, rooted in large Phase 2 studies.
The halt underscores the broader risk profile of the company’s pipeline. In 2025, Bristol Myers Squibb experienced several late‑stage trial failures, including in schizophrenia and oncology, which have eroded investor confidence. The loss of a potential blockbuster in ACS adds to these headwinds, while the continuation of the other two trials offers a partial mitigation strategy. The event highlights the importance of diversified development programs and the impact of clinical outcomes on long‑term revenue prospects.
The market reaction reflects the perceived loss of a high‑growth asset. Analysts noted that the discontinuation of the ACS trial removes a significant revenue opportunity, while the ongoing AF and STROKE studies may still provide upside. The decision signals a shift in the companies’ research priorities and may prompt reallocation of resources to other pipeline candidates.
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