Bristol Myers Squibb (BMY) Delays Phase 3 Data Releases for Cobenfy and Milvexian to 2027
Pipeline Delays Overshadow Strong Financial Performance
Bristol Myers Squibb (BMS) achieved strong financial results in Q2 2026, with revenues of $12.97 billion. The blockbuster anticoagulant, Eliquis, drove short-term growth with a 21% increase, reaching $4.5 billion in quarterly sales. However, market attention is now focused on the delayed Phase 3 data releases for key pipeline assets, now expected in 2027. BMS faces the challenge of demonstrating long-term growth potential and mitigating the impact of Eliquis's patent expiration, and the delayed timelines for new drug approvals add to this challenge.
Cobenfy's Delayed Alzheimer's Psychosis Trial and the Race for Market Leadership
BMS acquired Karuna for $14 billion to gain access to Cobenfy (xanomeline-trospium), a muscarinic M1/M4 receptor agonist. The Phase 3 trial for Alzheimer's Psychosis (ADP) has been delayed to 2027. Cobenfy was approved as an innovative new drug for schizophrenia on September 26, 2024, without an advisory committee review. Currently, approximately 1 million patients in the U.S. suffer from ADP, a market estimated at $1.2 billion in 2022, with no approved treatments. With competitors like Acadia's remlarsen vying for market share, this delay raises concerns about delaying the opportunity to establish a leading position in the market.
The Paradox of Milvexian's Trial Delay and the Reshaping of the Anticoagulant Market
The Phase 3 trial for milvexian, a next-generation Factor XIa inhibitor, targeting atrial fibrillation (LIBREXIA-AF), has also been delayed to Q1 2027. BMS, in collaboration with Janssen, must overcome the setback of the LIBREXIA-ACS trial, which was halted in November 2025 due to insufficient efficacy. The company views this delay positively, citing that the lower-than-expected incidence of clinical events indicates improved safety. With Bayer's competing drug, asundexian, withdrawn, milvexian now has the opportunity to capture a significant share of the next-generation anticoagulant market, potentially generating billions of dollars in annual revenue, pending demonstration of its safety profile.
Valuation Stagnation Until 2027 and the Key to Future Momentum
BMS has strengthened its fundamentals by raising its full-year 2026 revenue guidance to $49 billion to $50 billion, but the data gap in its key pipeline assets has emerged. As a result, the stock's upward momentum is likely to be limited until the major trials conclude in early 2027. Investors will closely monitor the progress of competitors, such as AbbVie's acquisition of Cerevel and its emraclidine, as well as the interim analysis of Cobenfy, which is expected later this year. Ultimately, BMS's value re-evaluation will depend on demonstrating clear efficacy and a favorable safety profile in the delayed trials.
BMS reported $12.97 billion in Q2 2026 revenue, but the Phase 3 trials for Cobenfy (xanomeline-trospium), acquired in a $14 billion deal, targeting Alzheimer's Psychosis (ADP), and milvexian (milvexian), a follow-up growth driver targeting atrial fibrillation, have been delayed to 2027. The ADP market, with approximately 1 million patients in the U.S., represents a $1.2 billion market with significant unmet needs. Cobenfy's ability to secure its position as the first treatment in this market, ahead of competitors like Acadia's remlarsen, is crucial for its commercial success. The delay in the milvexian trial, intended to address the patent expiration of Eliquis, which generates approximately $15 billion in annual revenue, may lead to short-term valuation stagnation. However, with Bayer's asundexian withdrawn, the potential for milvexian to demonstrate a favorable safety profile due to the lower incidence of clinical events could be a key differentiator in the long term. Therefore, rather than being satisfied with the short-term upward revision of revenue guidance ($49 billion to $50 billion), investors should monitor early indicators, such as the Adept-1 interim analysis of Cobenfy expected in late 2026, to determine the timing of a potential mid-to-long-term valuation adjustment.