GlobeNewswire·Oct 19, 2026, 7:30 AM ET

Cytokinetics Announces Health Canada Approval of MYQORZO® (aficamten) for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy

CYTK

Health Canada issued a Notice of Compliance for MYQORZO® (aficamten) to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult patients with NYHA class II-III.
MYQORZO is a once-daily, oral allosteric inhibitor that reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction.
This approval marks the fifth regulatory authorization for MYQORZO in under a year, following approvals by the FDA in December 2025, the NMPA in China, the European Commission, and the UK's MHRA.
The authorization is supported by positive Phase 3 SEQUOIA-HCM trial results published in the New England Journal of Medicine, which showed a 1.76 mL/kg/min increase in peak oxygen uptake (pVO2) compared to placebo after 24 weeks.
Treatment with MYQORZO was well-tolerated, with no instances of worsening heart failure or treatment interruptions due to low LVEF; hypertension was the only adverse reaction occurring in >5% of patients more frequently than with placebo.
A Boxed WARNING is included in the Product Monograph regarding the risk of heart failure due to systolic dysfunction, with specific LVEF monitoring requirements: initiation is not recommended for LVEF <55%, dose reduction is advised for LVEF ≥40% and <50%, and dose interruption is required for LVEF <40% or worsening heart failure.
Cytokinetics plans to submit a Supplemental New Drug Application in Q4 2026 for aficamten to treat non-obstructive HCM (nHCM) based on positive topline results from the ACACIA-HCM trial.
Aficamten is currently under investigation in the CEDAR-HCM pediatric trial, though safety and efficacy have not been established in pediatric populations.