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Cytokinetics Announces Positive Results from ACACIA-HCM Presented in Hot Line Session at the European Society of Cardiology (ESC) Congress 2026 and Published in The New England Journal of Medicine

CYTK
  • Cytokinetics announced positive primary results from the ACACIA-HCM Phase 3 trial of aficamten for symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), presented at the ESC Congress 2026 & published in The New England Journal of Medicine.
  • The trial met both dual primary endpoints with statistically significant improvements from baseline to Week 36 compared to placebo in KCCQ-CSS (p=0.021) & maximal exercise performance (pVO2) (p=0.003).
  • Cytokinetics plans to submit a supplemental New Drug Application to the FDA in the fourth quarter of 2026 for aficamten to treat adult patients with symptomatic nHCM.
  • Improvements in KCCQ-CSS & pVO2 were consistent across all prespecified subgroups, including patients with varying LVEF, atrial fibrillation status, genotype, age, sex, & background beta-blocker therapy.
  • Secondary endpoints showed statistically significant improvements in NYHA Functional Class, a composite z-score of CPET parameters, & NT-proBNP levels, while endpoints for left atrial volume index & time to first cardiovascular event did not meet statistical significance.
  • Safety data indicated aficamten was generally well-tolerated, though 10.5% of patients on aficamten experienced LVEF <50% compared to 0.8% on placebo, with most heart failure events occurring during dose titration & responsive to diuretics.
  • A global efficacy analysis published in Circulation demonstrated statistically significant improvements across five key domains (exercise capacity, cardiac structure, biomarkers, diastolic function, & symptom burden) with 53% of aficamten patients showing a clinical response in three or more measures.
  • Aficamten is currently approved in the U.S., China, EU, & UK for obstructive HCM (oHCM) under the brand name MYQORZO, which carries a warning for risk of heart failure due to reduced LVEF & requires a restricted REMS program.
  • The ACACIA-HCM trial randomized 517 participants in a 1:1 ratio, requiring baseline LVEF ≥60% & specific symptom criteria, with patients receiving escalating doses of aficamten based on echocardiographic guidance.
  • Cytokinetics will host an investor event in Munich on August 28, 2026, at 2:00 PM Central European Summer Time (8:00 AM Eastern Time), which will also be webcast live.