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Cytokinetics Launches MYQORZO® (aficamten) in European Union, with First Commercial Availability in Germany

CYTK
  • Cytokinetics, Incorporated announced the first commercial European launch of MYQORZO (aficamten) in Germany on June 01, 2026, for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults.
  • This launch follows European Commission approval granted in February 2026 based on positive results from the pivotal SEQUOIA-HCM Phase 3 clinical trial.
  • MYQORZO is an allosteric & reversible inhibitor of cardiac myosin motor activity that reduces cardiac contractility & left ventricular outflow tract (LVOT) obstruction.
  • The SEQUOIA-HCM trial demonstrated robust efficacy, safety, & clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, & biomarker endpoints, with results published in the New England Journal of Medicine.
  • Treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) by 1.76 mL/kg/min versus 0.0 mL/kg/min in the placebo group.
  • Statistically significant improvements were observed in all 10 prespecified secondary endpoints, including Kansas City Cardiomyopathy Questionnaire scores, NYHA functional class improvements, & reductions in LVOT gradients.
  • MYQORZO was previously approved by the U.S. FDA in December 2025 & by the China National Medical Products Administration (NMPA) for similar indications.
  • The drug is engineered for predictable exposure response, rapid onset of action, & reversibility, with consistent treatment effects across all prespecified subgroups including age, sex, & beta-blocker therapy status.
  • Cytokinetics is preparing to present full results from the ACACIA-HCM Phase 3 trial of aficamten in non-obstructive HCM patients at an upcoming medical meeting & will discuss them with the U.S. FDA.
  • Aficamten is under clinical investigation in the CEDAR-HCM pediatric trial & the FOREST-HCM open-label extension study, though safety & efficacy have not been established in pediatric populations.
  • Hypertrophic cardiomyopathy affects approximately 1 out of 350 individuals worldwide, with roughly half of cases being obstructive HCM (oHCM).