FDA accepts Bristol Myers sNDA for Camzyos in adolescent obstructive hypertrophic cardiomyopathy under priority review

Bristol-Myers Squibb

Bristol-Myers Squibb

BMY

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  • FDA accepted Bristol Myers Squibb’s sNDA for Camzyos to treat adolescents 12 to under 18 with symptomatic obstructive hypertrophic cardiomyopathy.
  • Priority Review granted; PDUFA target date set for Sept. 30, 2026.
  • Filing backed by Phase 3 SCOUT-HCM data showing reduced LVOT gradient at Week 28 versus placebo; safety profile broadly consistent with adults.


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