Bristol‑Myers Squibb and Johnson & Johnson announced that the Librexia Phase 3 trial of the oral factor XIa inhibitor milvexian in patients with acute coronary syndrome (ACS) will be discontinued after an independent data monitoring committee concluded the study was unlikely to meet its primary efficacy endpoint.
Milvexian had been positioned as a first‑in‑class anticoagulant that could have captured a large share of the global ACS market, which is estimated at more than 7 million patients worldwide. The termination removes a potential multi‑billion‑dollar revenue stream and underscores the difficulty of translating factor XIa inhibition into clinical benefit in the ACS setting.
The decision adds pressure to Bristol‑Myers Squibb’s cardiovascular portfolio, which has been a key growth engine as the company faces patent expirations on older products. The loss of this trial highlights the challenges of diversifying the pipeline and the importance of rigorous clinical evaluation for new therapeutic classes.
Bristol‑Myers Squibb will continue to pursue two other Phase 3 studies of milvexian—Librexia AF for atrial fibrillation and Librexia STROKE for secondary stroke prevention—with topline data expected in 2026. Management has expressed confidence that the different patient populations and endpoints in those trials may still yield positive outcomes.
"Together with Johnson & Johnson, we remain confident in the potential of milvexian to redefine anticoagulant therapy," said Roland Chen, senior vice president of Bristol‑Myers Squibb. "The ongoing AF and STROKE studies differ significantly from the discontinued ACS trial and will provide further insight into the drug’s therapeutic value."
Robert Harrington, chair of the Librexia program, added that the results "confirm the complexity of treating ACS" and that factor XIa inhibition "continues to be a promising mechanism within the broader thrombotic treatment space," noting that the trial did not raise new safety concerns.
Bristol‑Myers Squibb’s Q3 2025 financial results—revenue of $12.2 billion and non‑GAAP earnings per share of $1.63—beat analyst expectations, reflecting strong performance in core segments. The discontinuation of the ACS trial introduces uncertainty into the company’s future growth trajectory, as the potential blockbuster asset is no longer part of the pipeline.
The halt of the Librexia ACS study illustrates the high stakes of developing novel anticoagulants and reinforces the company’s commitment to rigorous clinical standards before advancing to market launch.
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