BMS's Camzyos hits Week 28 goal in teens, sets up Sept. 30 FDA call
SCOUT-HCM cut Valsalva LVOT gradient by 48.0 mm Hg versus placebo, and the FDA will decide by September 30 whether that extends Camzyos to adolescents with obstructive HCM.
Executive Summary
- The FDA is weighing whether to extend Camzyos's existing adult oHCM label down into adolescents, a bridging decision rather than a first-in-disease approval call.
- The efficacy question behind this filing is already resolved: the pivotal trial hit its primary endpoint with a statistically significant effect and a safety profile the sponsor says matches the adult experience.
- If cleared, Camzyos would become the first cardiac myosin inhibitor available to adolescents with obstructive hypertrophic cardiomyopathy, widening access to a mechanism only available to adults today.
- The competitive field around this mechanism and indication stays sparse, so the label decision matters more for access than for competitive share.
The filing
The FDA accepted Bristol Myers Squibb's supplemental New Drug Application for Camzyos (mavacamten) in adolescents ages 12 to under 18 with symptomatic obstructive hypertrophic cardiomyopathy and granted it Priority Review, setting a PDUFA target action date of September 30, 2026. Camzyos is already approved for adults with NYHA class II-III oHCM and has been prescribed to almost 25,000 U.S. patients by more than 4,500 providers, so this filing is a label extension into a younger population rather than a first approval decision. U.SU.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)Jun 1, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The trial behind it
The submission rests on the Phase 3 SCOUT-HCM trial (NCT06253221), a randomized, double-blind, placebo-controlled study that enrolled 44 adolescents across sites in the United States, Italy, Australia, Canada, France, Germany, Spain, the United Kingdom and Ireland. The trial's primary endpoint is change from baseline to Week 28 in Valsalva left ventricular outflow tract gradient, and Bristol Myers Squibb reported that Camzyos produced a least-squares mean difference of -48.0 mm Hg versus placebo (95% CI -67.7 to -28.3, P < 0.0001). No patient in the 28-week placebo-controlled period developed a left ventricular ejection fraction below 50%, and the sponsor described the safety profile as similar to what has been seen in adults. NCT06253221+1A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic CardiomyopathyNCT06253221U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)Jun 1, 2026
Design and status
SCOUT-HCM runs in three periods totaling up to 200 weeks: the 28-week placebo-controlled period already reported, a 28-week active-treatment period in which placebo patients cross over to Camzyos, and an open-label extension of up to 144 weeks. The trial is Active, not recruiting, with its primary completion date now listed as November 25, 2025, moved forward from an earlier February 2028 projection recorded in the registry, alongside an enrollment update from 40 to 44 patients logged the same day. Executive Vice President and Chief Medical Officer Cristian Massacesi said the sNDA acceptance gives Bristol Myers Squibb "the potential to extend our leadership in oHCM to a younger patient population with a high unmet medical need". U.S+1U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)Jun 1, 2026A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic CardiomyopathyNCT06253221
The competitive field
Mavacamten was the first cardiac myosin ATPase inhibitor approved in adult oHCM, and the field studying this target in hypertrophic cardiomyopathy stays narrow: only two active trials study cardiac myosin ATPase inhibition in the indication. Aficamten, from Cytokinetics, is the nearest mechanism neighbor, targeting a different cardiac myosin protein (MYH7) and running its own pediatric oHCM study, but no trial shares Camzyos's exact target and indication combination in the adolescent population. If approved, Camzyos would be the first cardiac myosin inhibitor available to adolescents with oHCM, extending an already-validated mechanism to a population that currently has no approved option in this drug class. NCT06253221+1A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic CardiomyopathyNCT06253221U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Supplemental New Drug Application for Camzyos (mavacamten) to Treat Adolescents with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)Jun 1, 2026
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.