Bristol‑Myers Squibb and Johnson & Johnson announced that the Librexia ACS Phase 3 study, which tested the factor XIa inhibitor milvexian in addition to standard antiplatelet therapy for patients who recently experienced an acute coronary syndrome (ACS) event, will be discontinued. The decision follows an interim analysis by an independent data monitoring committee that concluded the trial was unlikely to meet its primary efficacy endpoint, while no new safety concerns emerged.
Milvexian is an oral, selective factor XIa inhibitor designed to reduce thrombotic risk with a lower bleeding profile than existing anticoagulants. The IDMC’s assessment that the study would not achieve its primary endpoint suggests that the drug’s benefit–risk balance in the high‑risk ACS population is insufficient, a finding that contrasts with the encouraging signals seen in the program’s other Phase 3 studies for atrial fibrillation and secondary stroke prevention.
The halt of the ACS trial does not end the Librexia program. The atrial fibrillation and stroke studies will continue as scheduled, with topline data expected in 2026. The decision signals a strategic pivot: Bristol‑Myers Squibb is tightening its cardiovascular portfolio to focus on indications where the therapeutic window appears more favorable, while still pursuing the broader potential of factor XIa inhibition in other thrombotic settings.
Bristol‑Myers Squibb’s Q3 2025 financials provide context for the impact of this development. Revenue rose 3% to $12.2 billion, driven by a 18% increase in the Growth Portfolio, which now accounts for a larger share of the company’s top line. Non‑GAAP earnings per share fell to $1.63 from $1.80 in Q3 2024, reflecting the cumulative effect of pricing pressure in legacy products and the cost of ongoing pipeline investments. The company has raised its 2025 revenue guidance to $47.5 billion–$48.0 billion, underscoring confidence in its growth strategy despite the setback in the ACS trial.
Management emphasized both resilience and caution. Senior Vice President Roland Chen stated that the company remains confident in milvexian’s potential to redefine anticoagulant therapy, while program chair Robert Harrington noted that the ACS results highlight the complexity of treating acute coronary events but do not diminish the promise of factor XIa inhibition in other contexts. CEO Christopher Boerner highlighted the broader shift toward innovative oncology, hematology, and specialty medicines, positioning the company to capitalize on high‑margin growth areas.
Analysts have weighed the implications of the trial discontinuation. William Blair noted that while the ACS and stroke indications share underlying atherothrombotic biology, the failure in ACS may temper expectations for the stroke study, though the atrial fibrillation indication remains distinct. The commentary reflects a nuanced view that the program’s future hinges on the outcomes of the remaining Phase 3 studies and the company’s ability to navigate the competitive anticoagulant landscape.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.