Cytokinetics Announces Health Canada Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy
Key Highlights
- ➤Health Canada authorizes MYQORZO (aficamten) for adults with symptomatic NYHA class II-III oHCM
- ➤MYQORZO reaches its fifth regulatory approval in less than a year
- ➤SEQUOIA-HCM: peak oxygen uptake improved 1.76 mL/kg/min versus 0.0 with placebo
- ➤MYQORZO’s Canadian Product Monograph includes a Boxed WARNING for heart failure
- ➤Cytokinetics plans a Supplemental New Drug Application for nHCM in Q4 2026
Expert Statements
Fady I. Malik, M.D., Ph.D., Cytokinetics’ Executive Vice President of Research & Development
“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.”
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.”
Rafik Tadros, M.D., PhD., Director of the Cardiovascular Genetics Centre at the Montreal Heart Institute
“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.”
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.”
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.”
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