SOUTH SAN FRANCISCO, Calif., Oct. 19, 2026 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that Health Canada has issued a Notice of Compliance authorizing MYQORZO® (aficamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) of New York Heart Association (NYHA) class II-III in adult patients. MYQORZO is a once-daily, oral allosteric and reversible inhibitor of cardiac myosin motor activity. In patients with oHCM, myosin inhibition with MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
“This company milestone marks the fifth regulatory approval for MYQORZO in less than a year and lays the foundation for its future availability for patients in Canada,” said Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development. “Cytokinetics is committed to the global HCM community, and we look forward to expanding access to MYQORZO to patients living with oHCM.”
The authorization in Canada, follows the approval of MYQORZO in December 2025 by the U.S. Food and Drug Administration (FDA) for the treatment of adults with symptomatic oHCM to improve functional capacity and symptoms, and by the China National Medical Products Administration (NMPA) for the treatment of adults with NYHA class II-III oHCM, to improve exercise capacity and symptoms. Earlier in 2026, the European Commission (EC) approved MYQORZO, and the Medicines and Healthcare products Regulatory Agency (MHRA) authorized its use across the United Kingdom.
“Many patients with obstructive HCM have spent years living with breathlessness, fatigue and functional limitations in their everyday lives, with limited options for non-invasive therapy,” said Rafik Tadros, M.D., PhD., Director of the Cardiovascular Genetics Centre at the Montreal Heart Institute. “With improvements in exercise capacity and symptoms observed in SEQUOIA-HCM and a well-tolerated profile, this approval is a major step forward, and I look forward to having it as an option for our patients in Canada.”
The approval by Health Canada is supported by positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated statistically significant and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.1
The results from SEQUOIA-HCM showed that treatment with aficamten for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.76 mL/kg/min compared to baseline in patients treated with MYQORZO versus 0.0 mL/kg/min in patients treated with placebo (least square mean (LSM) difference [95% CI] of 1.74 mL/kg/min [1.04 - 2.44]; p=0.000002).1 The treatment effect of MYQORZO was consistent across all prespecified subgroups, including age, sex, patient baseline characteristics, and in patients receiving or not receiving background beta-blocker therapy.
MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low LVEF. Treatment emergent serious adverse events occurred in 5.6% of patients on MYQORZO and 9.3% of patients on placebo. Core laboratory echocardiographic LVEF was observed to be 5% of patients and more commonly on MYQORZO than on placebo. MYQORZO-associated increases in blood pressure are consistent with relief of LVOT obstruction and improved cardiac output.
The Product Monograph for MYQORZO includes a Boxed WARNING for the risk of heart failure. MYQORZO reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
Echocardiogram assessments of LVEF and Valsalva left ventricular outflow tract gradient (LVOT-G) are required prior to and during treatment with MYQORZO to monitor for systolic dysfunction. Initiation of MYQORZO in patients with LVEF