Peptide News Digest

#Snda-Q4-2026

2 stories

Clinical Trials · View digest

Cytokinetics ACACIA-HCM and MAPLE-HCM Late-Breaking Additional Analyses Published in Circulation and JACC Heart Failure at ESC 2026

Cytokinetics (NASDAQ: CYTK) presented Saturday August 29, 2026 additional results from the Phase 3 ACACIA-HCM (Myqorzo aficamten for non-obstructive HCM) and MAPLE-HCM trials in a Late-Breaking Clinical Trial Session at ESC Congress 2026 Munich, with simultaneous publications in Circulation and Journal of the American College of Cardiology: Heart Failure. The ACACIA-HCM additional analyses examined improvements in cardiac structure and diastolic function in patients with non-obstructive HCM (LV mass reduction, LV wall thickness reduction, and LA volume reduction versus placebo at Week 36), extending the primary readout (KCCQ Clinical Summary Score and peak VO2) presented in the Hot Line Session Friday August 28 and simultaneously published in NEJM. The follow-up data strengthens the aficamten commercial case for supplemental NDA in Q4 2026 and continues to differentiate the cardiac myosin inhibitor mechanism from mavacamten (Camzyos, Bristol Myers Squibb) which is currently approved only for obstructive HCM.

Clinical Trials · View digest

Cytokinetics ACACIA-HCM Phase 3 Trial Hits Both Endpoints in Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy; Simultaneous NEJM Publication at ESC 2026 Munich

Cytokinetics (NASDAQ: CYTK) presented Friday August 28, 2026 the full results from the Phase 3 ACACIA-HCM trial of Myqorzo (aficamten, a next-generation cardiac myosin inhibitor) in adults with symptomatic non-obstructive hypertrophic cardiomyopathy at the European Society of Cardiology Congress 2026 in Munich, Germany, with simultaneous publication in The New England Journal of Medicine. The trial met both dual primary endpoints with statistically significant improvements from baseline to Week 36 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) and peak oxygen uptake (peak VO2) versus placebo, plus improvements on key secondary endpoints. LVEF <50% occurred in 10% of aficamten patients vs 1% on placebo, with rare treatment interruptions due to LVEF <40% and two serious heart failure adverse events associated with LVEF <50%. Cytokinetics plans to submit a Supplemental New Drug Application in Q4 2026. There are no currently-approved therapies for non-obstructive HCM, and the ACACIA readout positions aficamten as the potential first-in-class treatment for this indication after the July 2026 initial obstructive-HCM approval.