CAMZYOS (mavacamten)
Symptomatic obstructive hypertrophic cardiomyopathy in adolescents · Adolescents 12 to younger than 18 years with symptomatic obstructive hypertrophic cardiomyopathy
BMY · BMYBristol-Myers Squibb Company
Regulatory designations
Full timeline
5 milestonesFDA decision expected
FDA assigned a September 30, 2026 PDUFA date to the CAMZYOS sNDA for adolescents with symptomatic obstructive hypertrophic cardiomyopathy.
Bristol Myers Squibb — sNDA acceptance and PDUFA date↗FDA accepted the sNDA with Priority Review
FDA accepted the application based on the Phase 3 SCOUT-HCM trial and granted Priority Review.
Bristol Myers Squibb — sNDA acceptance and Priority Review↗Detailed SCOUT-HCM results were presented and published
CAMZYOS produced a clinically meaningful and statistically significant reduction in Valsalva left-ventricular outflow-tract gradient, with no new safety signals in the 44-patient trial.
Bristol Myers Squibb — Detailed Phase 3 SCOUT-HCM results↗SCOUT-HCM reported positive topline results
The Phase 3 trial met its primary endpoint and multiple secondary endpoints, and the safety findings were consistent with the established adult profile.
Bristol Myers Squibb — Positive SCOUT-HCM topline results↗Related News
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