Dateline: NEW YORK, November 14, 2025 – Bristol Myers Squibb (BMY) and Johnson & Johnson (JNJ) halted a late-stage heart drug trial after interim analysis showed the experimental treatment failed to meet efficacy targets.
The decision to stop the LIBREXIA ACS trial of milvexian, an oral blood clot prevention drug, represents a significant setback for both pharmaceutical giants’ cardiovascular portfolios and their joint development investment.
Key Takeaways
- Late-stage milvexian trial halted after disappointing interim results
- Drug targeted blood clot prevention in heart patients
- Joint Bristol Myers-J&J development program affected
Market Reaction & Context
Both companies announced the trial termination on Friday, with the decision coming after an independent data monitoring committee reviewed interim efficacy data 1. The halt affects the Phase 3 LIBREXIA ACS study, which was examining milvexian’s ability to prevent blood clots in patients who recently suffered acute coronary syndrome.
The cardiovascular drug market represents a crucial growth area for major pharmaceutical companies, with competitors like Pfizer and Bayer holding significant market share in anticoagulant therapies. Bristol Myers trades around 56 per share, while Johnson & Johnson hovers near 160.
Trial Background
Milvexian is an oral factor XIa inhibitor designed to prevent blood clots while potentially reducing bleeding risks compared to existing treatments 4. The LIBREXIA ACS trial was examining the drug’s efficacy and safety among post-acute coronary syndrome participants, marking the first major outcome study for this class of anticoagulants.
The companies had positioned the drug as a potential breakthrough in cardiovascular care, targeting patients at high risk for recurrent heart attacks and strokes. The trial’s design incorporated interim analyses to assess both effectiveness and safety profiles.
Financial Impact
The trial halt represents a material setback for both companies’ research and development investments in cardiovascular medicine. Bristol Myers has been working to diversify its portfolio beyond oncology, while Johnson & Johnson continues expanding its pharmaceutical division beyond consumer products and medical devices.
Development costs for late-stage cardiovascular trials typically range from 100 million to 300 million, though neither company disclosed specific investment figures for the milvexian program. The failure also affects future regulatory filing timelines and potential revenue projections.
Industry Context
The cardiovascular drug market remains highly competitive, with established players like Eliquis from Bristol Myers and Pfizer generating billions in annual revenue 2. Recent successes in the space include SGLT2 inhibitors like Jardiance from Eli Lilly and Boehringer Ingelheim, which have shown cardiovascular benefits beyond diabetes treatment.
The milvexian setback highlights the challenges pharmaceutical companies face in developing safer, more effective anticoagulants. Many promising candidates have failed in late-stage trials due to either insufficient efficacy or unacceptable bleeding risks.
Next Steps
Both companies said they will analyze the complete trial data to determine next steps for the milvexian program. The decision could affect other ongoing studies of the drug in different patient populations or indications.
Bristol Myers and Johnson & Johnson continue pursuing other cardiovascular development programs, though this setback may prompt reassessment of their joint research priorities and resource allocation strategies.
Not investment advice. For informational purposes only.
References
1“Bristol Myers, J&J Stop Late-Stage Trial After Heart Disease Treatment Falls Short”. Morningstar. Retrieved November 14, 2025.
2“Bristol Myers, J&J halt heart drug trial after interim review”. MarketScreener. Retrieved November 14, 2025.
3“Bristol-Myers Squibb Co”. Reuters. Retrieved November 14, 2025.
4“Trial design Oral factor xia inhibitor milvexian after a recent acute coronary syndrome”. ScienceDirect. Retrieved November 14, 2025.