BMYNovember 20, 2025 at 7:11 PM UTCPharmaceuticals, Biotechnology & Life Sciences

BMY halts Librexia ACS trial, tempering milvexian cardiovascular upside but leaving broader growth story intact

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What happened

Bristol Myers Squibb has stopped its Librexia ACS study after an interim analysis indicated that milvexian was unlikely to meet its primary goals in acute coronary syndrome, although other late‑stage milvexian studies are continuing. This setback comes as BMY is executing well operationally, with Q2 2025 results supporting raised full‑year revenue and EPS guidance and a strategy focused on its Growth Portfolio and diversification beyond Eliquis. Milvexian had been one of the more visible pipeline candidates intended to extend the company’s cardiovascular presence as Eliquis faces IRA pricing pressure starting in 2026. The discontinuation of this ACS trial therefore modestly reduces the probability‑weighted value of BMY’s cardiovascular pipeline and underscores the inherent risk in late‑stage clinical development. However, given the breadth of BMY’s oncology, neuroscience, and radiopharma assets, along with strong free cash flow generation, the event is more of a drag on long‑term optionality than a near‑term earnings or balance‑sheet issue.

Implication

The termination of the Librexia ACS study modestly erodes BMY’s ability to offset future Eliquis pressure with a next‑wave cardiovascular asset, slightly lowering the risk‑adjusted value of the milvexian franchise. Because other late‑stage milvexian trials continue, there remains some potential for the drug in different indications or patient populations, but investor expectations for a broad, flagship CV follow‑on should be tempered. Near term, this decision is unlikely to affect 2025 guidance or free cash flow, as milvexian was not a material contributor to consensus earnings in this timeframe. Strategically, the setback increases the importance of flawless execution in BMY’s Growth Portfolio—particularly Opdivo lifecycle extensions, Cobenfy’s launch, and the scaling of cell therapy and radiopharma platforms—to compensate for less certain CV pipeline upside. For portfolio positioning, the stock remains suitable for investors seeking a discounted large‑cap pharma with diversified growth drivers, but those who owned BMY primarily for cardiovascular pipeline renewal should reassess position size and time horizon in light of incrementally higher pipeline risk in this area.

Thesis delta

Our prior BUY thesis emphasized BMY’s ability to partially backfill future Eliquis pressure with pipeline assets, including cardiovascular programs such as milvexian, alongside oncology, neuroscience, and radiopharma growth. The Librexia ACS futility stop modestly weakens this component of the story by reducing confidence that milvexian will emerge as a broad, high‑impact cardiovascular successor, so we trim our implied pipeline contribution from this program and place more weight on non‑CV growth drivers. Overall, we maintain a constructive view on the shares given valuation support and diversified growth, but with a slightly lower conviction that the cardiovascular pipeline alone can meaningfully offset Eliquis headwinds.

Confidence

Medium-High