Cytokinetics’ MYQORZO Cleared for Obstructive HCM with Q2 2026 Germany Launch
The European Commission has approved Cytokinetics’ MYQORZO (aficamten) 5-20 mg for NYHA class II-III obstructive hypertrophic cardiomyopathy and plans first launch in Germany in Q2 2026. Phase 3 SEQUOIA-HCM data showed a 1.76 mL/kg/min increase in peak VO₂ (p=0.000002) versus placebo after 24 weeks, with 3.5% of patients experiencing reversible LVEF reductions below 50%.
1. EC Approval and Launch Plans
The European Commission granted marketing authorization for MYQORZO (aficamten) tablets in 5, 10, 15 and 20 mg strengths for adults with symptomatic (NYHA class II-III) obstructive hypertrophic cardiomyopathy. Cytokinetics intends to begin European commercialization with a first launch in Germany during the second quarter of 2026, offering flexible starting doses based on baseline LVOT obstruction severity.
2. SEQUOIA-HCM Trial Results
Approval was supported by pivotal Phase 3 SEQUOIA-HCM results, which demonstrated a statistically significant improvement in exercise capacity. Patients treated for 24 weeks showed a least-squares mean increase in peak oxygen uptake of 1.76 mL/kg/min compared to baseline, with a 95% CI of 1.04–2.44 and p=0.000002 versus placebo.
3. Safety Profile
MYQORZO’s most common adverse reactions included palpitations (7%), hypertension (7.7%) and dizziness (4.2%). In the treatment group, 3.5% of patients experienced reversible reductions in left ventricular ejection fraction below 50% (median 47%), with one case dropping below 40%, none requiring treatment interruption or associated with clinical heart failure.
4. Regulatory and Pipeline Status
MYQORZO is already approved in the U.S. and China for adult oHCM patients. Cytokinetics is also evaluating aficamten in ACACIA-HCM (Phase 3 non-obstructive HCM) and CEDAR-HCM (pediatric oHCM), with an open-label extension study (FOREST-HCM) ongoing.