Aficamten (CK-274) - (MAPLE-HCM)

Aug. 29, 2026: Cytokinetics (NASDAQ: CYTK) reported late-breaking ESC Congress 2026 data and simultaneous publications for aficamten in hypertrophic cardiomyopathy.

ACACIA-HCM (Phase 3, symptomatic non-obstructive HCM): A pre-specified exploratory analysis showed aficamten improved cardiac structure and diastolic function at Week 36 and end of treatment (up to 72 weeks; median 49 weeks). Significant improvements were reported in peak E velocity (p=0.001 at Week 36; p=0.034 at EOT) and septal e’ velocity (p<0.001 at both timepoints). Septal E/e’ trended better at Week 36 (p=0.07) and improved significantly at EOT (p<0.001); left atrial volume index also trended better at Week 36 (p=0.06) and improved at EOT (p=0.022). Left ventricular wall thickness decreased by 0.2 cm at EOT (p<0.001). LVEF declined modestly but remained in the normal range. The company said it plans to submit an sNDA for non-obstructive HCM in Q4 2026.

MAPLE-HCM (Phase 3, symptomatic obstructive HCM): In a post-hoc analysis, aficamten outperformed metoprolol regardless of prior beta-blocker use. pVO2 improved versus metoprolol by +3.1 mL/kg/min in prior non-users and +1.9 mL/kg/min in prior users (both p<0.001; interaction p=0.133). Aficamten also improved KCCQ-CSS, NYHA class, Valsalva LVOT gradient, and NT-proBNP, with no safety differences across pre-trial treatment groups.