BMY Down on Heart Drug Camzyos Failure in Late-Stage Study

Bristol Myers Squibb BMY suffered a setback in the late-stage ODYSSEY-HCM study evaluating cardiovascular drug Camzyos (mavacamten).

The phase III study was evaluating Camzyos for the treatment of adult patients with symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM).

The dual-primary endpoints for the trial were to examine changes from baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2) at week 48.  However, the study did not meet its dual primary endpoints.

BMY stock was down in after-hours trading on the disappointing study results.

Shares of BMY lost 7.2% year to date compared with the industry’s decline of 8.4%.

More on BMY’s Camzyos

Camzyos is a selective, reversible, allosteric inhibitor of cardiac myosin. It is indicated for the treatment of adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.

Sales of the drug totaled $602 million in 2024.

ODYSSEY-HCM is a double-blind, placebo-controlled trial that enrolled 580 adult patients and tested the hypothesis of whether a cardiac myosin inhibitor would improve measures of feel and function for patients with nHCM.

While the results of the study were disappointing, no new safety signals were observed.

Meanwhile, shares of late-stage biopharmaceutical company Cytokinetics, Incorporated CYTK were also trading down in after-market hours.

The company’s lead candidate, aficamten, is a novel, oral, small-molecule cardiac myosin inhibitor designed to reduce the hypercontractility associated with HCM. The candidate is under review in the United States and has a target action date of Sept. 26, 2025.

Shares of Cytokinetics were down, most likely due to the setback faced by Camzyos in nHCM, raising concerns about the efficacy of cardiac myosin inhibitors in nHCM.

BMY Looks to Solidify Portfolio

BMY’s Growth Portfolio, comprising drugs like Reblozyl, Breyanzi, Camzyos and Opdualag, has stabilized its revenue base amid generic competition for its legacy drugs.

Label expansion of these drugs should further fuel sales.

Blockbuster immuno-oncology drug Opdivo continues to maintain momentum on consistent label expansions. The FDA approval of Opdivo Qvantig injection for subcutaneous use is expected to help extend the impact of its immuno-oncology franchise to patients into the next decade.

The company had earlier obtained FDA approval for xanomeline and trospium chloride (formerly KarXT), an oral medication for the treatment of schizophrenia in adults, under the brand name Cobenfy. The approval of Cobenfy for schizophrenia broadens BMY’s portfolio.

BMY also recently agreed to acquire 2seventy Bio, Inc. for $286 million. Both companies have an agreement in place, under which they equally share profits and losses related to the development, manufacturing and commercialization of Abecma in the United States.

BMY's Zacks Rank & Stocks to Consider

Bristol Myers currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Amicus Therapeutics, Inc. FOLD and ANI Pharmaceuticals, Inc. ANIP, both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Amicus Therapeutics

In the past 60 days, estimates for Amicus’ earnings per share (EPS) have increased from 43 cents to 52 cents for 2025. During the same time frame, EPS estimates for 2026 have increased from 71 cents to 79 cents.

FOLD’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 45.42%.

ANI Pharmaceuticals

In the past 60 days, estimates for ANI Pharmaceuticals’ EPS have increased from $5.54 to $6.34 for 2025. During the same period, EPS estimates for 2026 have increased from $6.75 to $7.13. Year to date, shares of ANIP have rallied 24.3%.

ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%.

 

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