Bristol Myers Squibb and Johnson & Johnson will continue to test the asset in stroke and atrial fibrillation.
Bristol Myers Squibb is discontinuing a late-stage study of the investigational drug milvexian for treating acute coronary syndrome, after a preplanned interim analysis of the study revealed the drug was on track to miss its primary endpoint.
The Phase III Librexia ACS trial was studying the oral factor XIa inhibitor milvexian, which aims to block clotting events that could stop blood flow in conditions like acute coronary syndrome (ACS), a condition of decreased flow to the heart.
The drug was developed in collaboration with Johnson & Johnson.
Analysts at BMO Capital Markets, writing after the announcement Friday morning, called the decision a “tougher update” for BMS, as it “likely removes the opportunity for milvexian in acute coronary syndrome, a market that BMY had previously estimated could be as large as ~2 million patients across the US and EU.”
Shares of BMS are down 3.4% to about $47 in Friday morning trading.
BMS and J&J still have opportunities with milvexian. The companies are continuing two other Phase III trials testing the molecule in atrial fibrillation and secondary stroke prevention, with topline data expected in 2026. The sales opportunities from treating those conditions softened the blow for investors, BMO said.
“An opportunity remains for milvexian with additional readouts on the horizon,” the analysts wrote. “Bristol previously categorized the opportunity for milvexian in secondary stroke prevention as ~1.3 million patients across the US and EU. The opportunity in atrial fibrillation is even more substantial with the company previously highlighting ~14 million addressable patients across the US and EU.”
ACS is a broad umbrella term for conditions where blood flow to the heart becomes restricted, usually because of a clot. That can lead to heart attacks and angina. According to BMS, more than 7 million people are diagnosed with ACS worldwide.
BMS and J&J first linked together in 2018 to develop factor X1a inhibitors as anti-coagulants. The three Phase III Librexia programs were launched by BMS and J&J in March 2023. In May of that year, the whole program for all three indications received FDA Fast Track designation.
