European Commission Approves MYQORZO for Obstructive Hypertrophic Cardiomyopathy
The European Commission approved MYQORZO (aficamten) for treating symptomatic obstructive hypertrophic cardiomyopathy in adults, completing global regulatory approvals following FDA and China NMPA clearances. First European launch planned in Germany in Q2 2026.
Cytokinetics, Incorporated (Nasdaq: CYTK) announced that the European Commission has approved MYQORZO (aficamten), 5 mg, 10 mg, 15 mg and 20 mg tablets for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (oHCM) in adult patients. The approval, granted on February 17, 2026, follows successful clearances in the United States and China in late 2025.
MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and consequently, left ventricular outflow tract (LVOT) obstruction. The drug is designed to address the underlying pathophysiology of oHCM by lowering left ventricular outflow tract obstruction, a primary driver of symptoms such as shortness of breath, chest pain and exercise intolerance.
The European Commission approval was supported by robust results from the pivotal Phase 3 SEQUOIA-HCM clinical trial. This 24-week study, which involved 282 patients, demonstrated that MYQORZO significantly improved exercise capacity, measured by a 1.8 mL/kg/min increase in peak oxygen uptake (pVO2) at 24 weeks, compared to 0.0 mL/kg/min in patients treated with placebo. Nearly 60% of patients treated with the drug showed an improvement of at least one NYHA functional class. Benefits were consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy.
The European Commission decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which had earlier issued a recommendation for marketing authorization in the EU for MYQORZO to treat symptomatic oHCM in adult patients.
In late December 2025, the FDA approved MYQORZO for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, marking the company's first FDA-approved product and transforming Cytokinetics from a development-stage biotech into a commercial-stage company. The drug is also approved in China by the National Medical Products Administration (NMPA) for the treatment of adults with NYHA class II-III oHCM, to improve exercise capacity and symptoms.
Cytokinetics is currently gearing up to make MYQORZO available in the EU, beginning with the first launch in Germany in the second quarter of 2026. The European label allows providers flexibility to determine whether a patient starts treatment at either 5 mg or 10 mg, based on the severity of their baseline LVOT obstruction.
From a safety perspective, MYQORZO was generally well tolerated in the SEQUOIA-HCM trial. Over the 24-week treatment period, 3.5% of patients receiving the therapy experienced a reversible, dose-dependent decline in left ventricular ejection fraction (LVEF) to below 50%. One patient in the treatment arm developed an asymptomatic LVEF below 40%. These reductions to below 50% did not necessitate treatment discontinuation and were not linked to clinical heart failure. The most frequently reported adverse reactions with MYQORZO included dizziness, systolic dysfunction defined as LVEF below 50%, palpitations and hypertension.
The drug has already been made available in the United States and China, setting the stage for near-term revenue generation. MYQORZO will face competition from Camzyos (mavacamten), a first-in-class cardiac myosin inhibitor marketed by Bristol Myers Squibb (NYSE: BMY). Bristol Myers Squibb obtained FDA approval of Camzyos in 2022 for the treatment of adults with symptomatic (New York Heart Association class II-III) obstructive HCM to improve functional capacity and symptoms.
Hypertrophic cardiomyopathy (HCM) is the most prevalent monogenic inherited cardiovascular disease. Approximately half of all HCM patients have oHCM, while the remaining half have non-obstructive HCM. The oHCM market represents a meaningful commercial opportunity, with a substantial population of symptomatic patients who have historically had limited pharmacologic options beyond beta-blockers, calcium channel blockers, or invasive procedures.
CYTK shares have surged 76.1% in the last six months. Following the European Commission's announcement, the stock saw a modest immediate increase of nearly 2%.