Aficamten superior to metoprolol in MAPLE-HCM Phase 3 trial; primary endpoint met (p<0.0001)

CYTOKINETICS INC

Least-squares mean pVO2 difference: +2.3 mL/kg/min (95% CI 1.5 to 3.1; p<0.0001) favoring aficamten.
51% of aficamten patients improved ≥1 NYHA class vs 26% on metoprolol (p<0.001).
Aficamten reduced NT-proBNP by 81% vs metoprolol (p<0.0001); 1 patient had LVEF<50%.
FDA PDUFA target action date for aficamten NDA is December 26, 2025.
Results published simultaneously in The New England Journal of Medicine.

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