BMS's Camzyos Fails to Meet Primary Endpoints in Phase III Trial for Non-Obstructive Hypertrophic Cardiomyopathy

Bristol Myers Squibb (BMS) announced on Monday that its myosin blocker Camzyos failed to demonstrate new benefits in patients with non-obstructive hypertrophic cardiomyopathy (HCM) during a Phase III clinical trial. The setback represents a significant blow to the company's efforts to expand the drug's label and market potential.

Trial Results and Implications

The Phase III ODYSSEY-HCM study, which aimed to evaluate Camzyos in non-obstructive HCM patients, did not meet its dual primary endpoints. These endpoints included a 48-week improvement in peak oxygen consumption and other symptoms such as shortness of breath and blood markers for potential heart failure.

While BMS did not disclose specific data in its news release, the company stated that no new safety concerns were identified during the trial. Detailed results from ODYSSEY-HCM are expected to be shared in the future, according to the company's statement.

Analysts at BMO Capital Markets noted that this failure removes the opportunity for Camzyos in approximately one-third of HCM patients who have the non-obstructive form of the disease. The potential label expansion into non-obstructive HCM is now considered "highly unlikely."

Market Impact and Future Outlook

The trial's negative outcome represents a significant missed opportunity for BMS. According to BMO Capital Markets, the label expansion for non-obstructive HCM would have presented a $1.3 billion market opportunity, potentially benefiting an additional 33,000 patients.

Despite this setback, Camzyos retains its potential in the treatment of obstructive HCM, with analysts projecting peak sales of approximately $2.7 billion. The drug, which works by inhibiting cardiac myosin to relax heart muscle and improve blood flow, received FDA approval for obstructive HCM in 2022.

BMS acquired Camzyos through its $13.1 billion purchase of MyoKardia in October 2020. The company continues to focus on strengthening its pipeline, with several "impactful catalysts" expected throughout 2025. These include upcoming data on Cobenfy for adjunctive schizophrenia and Alzheimer's psychosis, which analysts at BMO Capital Markets are closely monitoring.