Will Librexia ACS Study Setback Dent BMY's Cardiovascular Portfolio?

Bristol Myers Squibb BMY recently announced that it will discontinue the late-stage Librexia study on cardiovascular candidate milvexian, an investigational oral, highly selective factor XIa (FXIa) inhibitor.

BMY and partner Johnson & Johnson JNJ were evaluating the efficacy and safety of pipeline candidate milvexian when added to the standard of care (conventional antiplatelet therapy) for patients after a recent acute coronary syndrome (ACS) event.

However, BMY and JNJ decided to discontinue the phase III Librexia ACS study following a preplanned interim analysis by the Independent Data Monitoring Committee (“IDMC”), which determined that the study is unlikely to meet the primary efficacy endpoint.

The discontinuation of the phase III Librexia ACS study was a setback, given the market potential.

The successful development of milvexian for this indication would have boosted BMY’s cardiovascular portfolio, which comprises Camzyos (mavacamten), a first-in-class cardiac myosin inhibitor.

BMY obtained FDA approval of the drug in 2022 for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Nonetheless, the IDMC advised that the two other late-stage studies — Librexia AF for atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP) — should proceed as planned. Top-line data from these studies is expected in 2026.

BMY’s cardiovascular portfolio also comprises blood thinner medicine Eliquis, for which BMY has a worldwide co-development and co-commercialization agreement with pharma giant Pfizer PFE. Eliquis is one of the biggest contributors to the top line.

Competition for BMY’s Cardiovascular Drugs

Cytokinetics CYTK is developing aficamten, an investigational, oral, small-molecule cardiac myosin inhibitor. CYTK is currently seeking FDA approval for aficamten for the treatment of patients with obstructive HCM in the United States.

In May 2025, Cytokinetics announced that the FDA has extended the target action date for the new drug application NDA seeking approval of aficamten for obstructive HCM to Dec. 26, 2025.

A potential approval of aficamten will pose competition to Camzyos.  

JNJ’s Xarelto is also a Factor Xa inhibitor, similar to Eliquis.

However, JNJ is facing patent challenges for Xarelto in the United States.  JNJ co-developed Xarelto with Bayer AG.

BMY’s Price Performance, Valuation and Estimates

Shares of Bristol Myers have lost 19.1% year to date against the industry’s growth of 16.5%.

From a valuation standpoint, BMY is trading at a discount to the large-cap pharma industry.  Going by the price/earnings ratio, BMY’s shares currently trade at 7.55x forward earnings, lower than its mean of 8.41x and the large-cap pharma industry’s 16.84X.

The Zacks Consensus Estimate for 2025 earnings per share has moved north in the past 60 days, while that for 2026 EPS has moved south.

BMY currently carries a Zacks Rank #3 (Hold).  You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


 

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This article originally published on Zacks Investment Research (zacks.com).

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