Cytokinetics reports positive ACACIA-HCM results for aficamten in non-obstructive HCM

Cytokinetics announced on August 28, 2026 that its Phase 3 trial ACACIA-HCM met its dual primary endpoints for aficamten in patients with symptomatic non-obstructive hypertrophic cardiomyopathy. The data were shown at a Hot Line session during the European Society of Cardiology Congress 2026 in Munich, Germany, and the findings ran at the same time in The New England Journal of Medicine.¹

The trial showed that patients on aficamten improved significantly more than those on placebo, from baseline to week 36, on both the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and peak exercise oxygen uptake (pVO2).¹ Specific figures: KCCQ-CSS improved by an LSM of 11.4 points on aficamten versus 8.4 on placebo (difference 3.0, p=0.021), and pVO2 rose 0.64 ml/kg/min on drug versus -0.03 on placebo (difference 0.67, p=0.003), as shown in Table 1¹. Key secondary endpoints, including NYHA functional class improvement, a composite CPET z-score, and NT-proBNP, also reached statistical significance, while left atrial volume index and time to first cardiovascular event did not, the company said.¹

On safety, more patients on aficamten had serious adverse events (52, or 20.2%) than on placebo (38, or 14.7%).¹ A drop in LVEF below 50% occurred in 27 patients (10.5%) on aficamten versus two (0.8%) on placebo.¹

Cytokinetics plans to submit a supplemental New Drug Application to the FDA for aficamten in symptomatic non-obstructive HCM during the fourth quarter of 2026.¹ Aficamten is already sold under the brand MYQORZO for obstructive HCM in the U.S., China, the EU and UK, where it functions as a cardiac myosin inhibitor.¹