We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
BMY Stock Down on Discontinuation of ACS Clinical Study With JNJ
Read MoreHide Full Article
Key Takeaways
BMY ended the Librexia ACS study after an interim review found it unlikely to meet its primary efficacy goal.
The IDMC saw no new safety issues and advised that the Librexia AF and Librexia STROKE trials proceed.
BMY says these trials differ from Librexia ACS in patient groups, endpoints, background therapy.
Bristol Myers (BMY - Free Report) announced that it will discontinue the late-stage Librexia study 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.
BMY was developing the candidate in collaboration with Johnson & Johnson (JNJ - Free Report) .
BMY stock was down 4% on the news. Year to date, shares of Bristol Myers have lost 17.5% against the industry’s growth of 14.9%.
Image Source: Zacks Investment Research
More on BMY’s Cardiovascular Drug
Milvexian is an investigational oral, highly selective factor XIa (FXIa) inhibitor, part of a new class of anticoagulants in development aimed at preventing harmful clotting that restricts blood flow (thrombosis) while preserving the normal clotting process (hemostasis).
BMY and JNJ decided to discontinue the phase III Librexia ACS study following a preplanned interim analysis by the Independent Data Monitoring Committee (“IDMC”).
The IDMC determined that the study is unlikely to meet the primary efficacy endpoint. Nevertheless, no new safety concerns related to the investigational therapy were identified.
The primary endpoint is the time to the first occurrence of the composite endpoint of stroke and non-central nervous system (CNS) systemic embolism.
The Librexia clinical program also includes two other late-stage studies, Librexia AF for patients with atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP).
The IDMC recommended that these trials continue as planned. Top-line data from these studies is expected in 2026.
Both BMY and JNJ believe in the potential of milvexian to redefine anticoagulant therapy. BMY stated that the Librexia SSP and AF studies are distinct from Librexia ACS in key aspects, such as patient populations, endpoints, type and duration of background therapy, and disease pathology.
BMY’s Efforts to Diversify Portfolio
The discontinuation of the phase III Librexia ACS study was a setback, given the market potential.
Nonetheless, the successful development of milvexian for AF and SSP will boost 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.
We note that Cytokinetics, Incorporated (CYTK - Free Report) is currently seeking FDA approval of its lead candidate, aficamten, for the treatment of patients with obstructive HCM in the United States. Aficamten is an investigational selective, small-molecule cardiac myosin inhibitor.
In May 2025, CYTK 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.
Meanwhile, Bristol Myers is looking to expand its pipeline/portfolio, as the legacy portfolio is being adversely impacted due to the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
BMY recently announced that it will acquire privately held biotechnology company Orbital Therapeutics for $1.5 billion in cash.
The acquisition will add OTX-201, Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies, to BMY’s pipeline. OTX-201, a next-generation CAR T-cell therapy, is designed to reprogram cells in vivo with a potential best-in-class profile for autoimmune disease. BMY will also add Orbital’s proprietary RNA platform to its pipeline.
The company had earlier collaborated with BioNTech (BNTX - Free Report) for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types.
Under the agreement, BNTX and BMY will work jointly to broaden and accelerate the development of this pipeline candidate.
Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline.
Image: Shutterstock
BMY Stock Down on Discontinuation of ACS Clinical Study With JNJ
Key Takeaways
Bristol Myers (BMY - Free Report) announced that it will discontinue the late-stage Librexia study 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.
BMY was developing the candidate in collaboration with Johnson & Johnson (JNJ - Free Report) .
BMY stock was down 4% on the news. Year to date, shares of Bristol Myers have lost 17.5% against the industry’s growth of 14.9%.
Image Source: Zacks Investment Research
More on BMY’s Cardiovascular Drug
Milvexian is an investigational oral, highly selective factor XIa (FXIa) inhibitor, part of a new class of anticoagulants in development aimed at preventing harmful clotting that restricts blood flow (thrombosis) while preserving the normal clotting process (hemostasis).
BMY and JNJ decided to discontinue the phase III Librexia ACS study following a preplanned interim analysis by the Independent Data Monitoring Committee (“IDMC”).
The IDMC determined that the study is unlikely to meet the primary efficacy endpoint. Nevertheless, no new safety concerns related to the investigational therapy were identified.
The primary endpoint is the time to the first occurrence of the composite endpoint of stroke and non-central nervous system (CNS) systemic embolism.
The Librexia clinical program also includes two other late-stage studies, Librexia AF for patients with atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP).
The IDMC recommended that these trials continue as planned. Top-line data from these studies is expected in 2026.
Both BMY and JNJ believe in the potential of milvexian to redefine anticoagulant therapy. BMY stated that the Librexia SSP and AF studies are distinct from Librexia ACS in key aspects, such as patient populations, endpoints, type and duration of background therapy, and disease pathology.
BMY’s Efforts to Diversify Portfolio
The discontinuation of the phase III Librexia ACS study was a setback, given the market potential.
Nonetheless, the successful development of milvexian for AF and SSP will boost 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.
We note that Cytokinetics, Incorporated (CYTK - Free Report) is currently seeking FDA approval of its lead candidate, aficamten, for the treatment of patients with obstructive HCM in the United States. Aficamten is an investigational selective, small-molecule cardiac myosin inhibitor.
In May 2025, CYTK 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.
Meanwhile, Bristol Myers is looking to expand its pipeline/portfolio, as the legacy portfolio is being adversely impacted due to the continued generic impact on Revlimid, Pomalyst, Sprycel and Abraxane.
BMY recently announced that it will acquire privately held biotechnology company Orbital Therapeutics for $1.5 billion in cash.
The acquisition will add OTX-201, Orbital’s lead RNA immunotherapy preclinical candidate currently in IND-enabling studies, to BMY’s pipeline. OTX-201, a next-generation CAR T-cell therapy, is designed to reprogram cells in vivo with a potential best-in-class profile for autoimmune disease. BMY will also add Orbital’s proprietary RNA platform to its pipeline.
The company had earlier collaborated with BioNTech (BNTX - Free Report) for the global co-development and co-commercialization of BioNTech’s investigational bispecific antibody BNT327 across numerous solid tumor types.
Under the agreement, BNTX and BMY will work jointly to broaden and accelerate the development of this pipeline candidate.
Approval of additional new drugs and label expansion of top drugs should further diversify its pipeline.
BMY’s Zacks Rank
BMY currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.