Cytokinetics Myqorzo Receives EU Marketing Authorization for Obstructive Hypertrophic Cardiomyopathy
European Regulatory Approval
The European Commission (EC) approved Cytokinetics' (CYTK) Myqorzo (aficamten) on February 12, 2026, for the treatment of adult patients with symptomatic New York Heart Association (NYHA) Class II–III obstructive hypertrophic cardiomyopathy (oHCM). This final marketing authorization followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) on December 11, 2025. The U.S. Food and Drug Administration (FDA) also approved the drug on December 19, 2025, for the improvement of functional capacity and symptoms, marking Myqorzo's transition from development to commercial stages in the U.S. and Europe.
First Oral, Reversible Allosteric Inhibitor Targeting Cardiac Myosin
Myqorzo is an oral, reversible allosteric inhibitor that directly binds to the motor domain of cardiac myosin. It reduces myocardial contractility and left ventricular outflow tract (LVOT) obstruction by decreasing the force-generating state of myosin, offering a disease-targeted approach distinct from symptom management with beta-blockers, verapamil, diltiazem, and disopyramide. The approved EU dosages are 5, 10, 15, and 20 mg. Left ventricular ejection fraction monitoring is critical to commercial success due to the risk of systolic dysfunction and heart failure.
Phase 3 SEQUOIA-HCM Trial as Basis for Approval
Approval was based on the Phase 3 SEQUOIA-HCM trial (NCT05186818), which enrolled 282 adults. After 24 weeks, peak oxygen uptake (pVO2) increased by 1.76 mL/kg/min in the Myqorzo group compared to 0.0 mL/kg/min in the placebo group, with a least squares mean difference of 1.74 mL/kg/min (95% CI 1.04–2.44, p=0.000002). The objective improvement in exercise capacity via cardiopulmonary exercise testing is a favorable factor for both regulatory approval and reimbursement negotiations. However, real-world adoption will depend on the availability of echocardiography and the prescribing capabilities of specialized centers.
Direct Competition with Camzyos in the European Market
The direct competitor is Bristol Myers Squibb's (BMY) cardiac myosin inhibitor Camzyos (mavacamten), which received FDA approval on April 28, 2022, and EC approval on June 26, 2023. Camzyos generated global sales of $1.068 billion in 2025, a 77% increase from $620 million in 2024, demonstrating strong demand for targeted therapies. The global HCM treatment market was estimated at $1.4 billion in 2025, and Myqorzo's EU approval transforms a previously exclusive market into a competitive landscape, promoting comparisons of drug pricing, reimbursement, and monitoring convenience.
Cytokinetics (CYTK) has expanded Myqorzo's commercial reach from the U.S. to the European Union, reducing reliance on a single market. The least squares mean difference of 1.74 mL/kg/min in pVO2 observed in the Phase 3 SEQUOIA-HCM trial will serve as a key clinical evidence for payers and specialists to evaluate Myqorzo's value compared to Camzyos. Camzyos reported $1.068 billion in 2025 sales, and the global HCM treatment market was valued at $1.4 billion in 2025, making early market share shifts significant for CYTK's valuation. In the short term, drug pricing and echocardiography monitoring systems will determine launch speed across countries. In the medium to long term, the expansion of myosin inhibitor use after standard-of-care therapies like beta-blockers and the prescribing competition with Camzyos will drive market growth.
Source: EMA (ema)