Cytokinetics Succeeds Against Bristol Myers' Failure in HCM: FDA Approves Myqorzo as Camzyos Fails nHCM Trial
Bristol Myers Squibb's Camzyos failed Phase 3 ODYSSEY-HCM trial in non-obstructive hypertrophic cardiomyopathy (nHCM) on April 14, 2025, missing dual primary endpoints.
Camzyos failure suggests oHCM and nHCM are distinct diseases, raising concerns for similar cardiac myosin inhibitors like Cytokinetics' aficamten in nHCM.
FDA approved Cytokinetics' Myqorzo (aficamten) for symptomatic obstructive HCM (oHCM) in adults (Class II/III), its first U.S. approval, with launch in H2 January.
Myqorzo shows competitive or superior efficacy to Camzyos in oHCM Phase 3 trials, plus more flexible dosing and less restrictive risk mitigation.
Cytokinetics' aficamten under FDA review for oHCM and in Phase 3 for nHCM, positioning it to challenge Camzyos despite BMS setback.