Bristol Myers says Camzyos fails Phase 3 study in genetic heart condition

Title

Bristol Myers' Camzyos Fails Phase 3 Trial in Non-Obstructive Hypertrophic Cardiomyopathy

Keywords

Bristol Myers Squibb
Camzyos
Phase 3 trial
ODYSSEY-HCM
non-obstructive hypertrophic cardiomyopathy (nHCM)
clinical trial failure
cardiac myosin inhibitor
heart disease drug development
label expansion
obstructive vs non-obstructive HCM

Key Facts

Bristol Myers Squibb’s heart failure drug Camzyos (mavacamten) failed to meet both primary endpoints in the Phase 3 ODYSSEY-HCM trial for adults with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM)1 2 3 4 5 7 8 10.
The study evaluated Camzyos’ effect on the Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2) over 48 weeks, but the drug did not show improvement compared to placebo1 2 10.
No new safety concerns were identified during the trial, and Camzyos’ safety profile remains consistent with previous studies in obstructive HCM (oHCM)1 2 7.
Camzyos is already approved by the FDA to treat obstructive HCM, but this latest failure blocks potential label expansion for the non-obstructive form; analysts estimate the missed opportunity could have been worth $1.3 billion in annual sales2 4 7.
Experts note the trial’s results reinforce that obstructive and non-obstructive HCM are distinct conditions, suggesting different therapeutic approaches may be necessary1 7 10.
Despite this setback, Camzyos continues to perform well in the approved oHCM market, generating $602 million in sales last year with projections to reach blockbuster status7 10.
The failure adds pressure on Bristol Myers Squibb’s cardiovascular pipeline, especially as it seeks new growth drivers ahead of key patent expiries7.
Detailed trial data will be shared at future scientific meetings, and the outcome may influence the development of similar drugs for nHCM by competitors like Cytokinetics7 10.