Cytokinetics presents positive aficamten data at ESC 2025; PDUFA Dec 26, 2025

CYTOKINETICS INC

MAPLE-HCM: aficamten improved cardiac structure/function vs metoprolol (p<0.001 for diastolic function, SAM reduction); published in JACC.
New analysis shows aficamten AF incidence 1.5%/year, consistent with HCM prediction model (3.6%/year) and healthy model (1.4%/year); published in Heart Rhythm.
FOREST-HCM: 93% of patients had ≥1 NYHA class improvement at 96 weeks; sustained hemodynamic benefits with low LVEF <50% (0.3% discontinuation).
Integrated safety (463 patients, ~700 patient-years): aficamten well-tolerated, AE profile similar to placebo; new-onset AF 1.9% vs placebo 2%.
FDA NDA under review; PDUFA target action date December 26, 2025.

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