Cytokinetics secures Canadian MYQORZO approval after 24-week trial

• Cytokinetics received Health Canada approval for MYQORZO (aficamten) to treat adults with symptomatic obstructive hypertrophic cardiomyopathy classified as NYHA class II–III.
• The Phase 3 SEQUOIA-HCM trial showed an adjusted improvement of 1.74 mL/kg/min in peak oxygen uptake versus placebo after 24 weeks.
• The authorization expands MYQORZO's regulatory footprint to Canada, following approvals in the United States, China, European Union and United Kingdom.

Cytokinetics (NASDAQ:CYTK) received Health Canada approval for MYQORZO to treat adults with NYHA class II–III symptomatic obstructive hypertrophic cardiomyopathy, supported by 24-week trial results.

The approval follows earlier authorizations in four markets, with SEQUOIA-HCM demonstrating a 1.74 mL/kg/min adjusted improvement in peak oxygen uptake versus placebo.

Cytokinetics said the Canadian authorization marks MYQORZO's fifth regulatory approval, following its U.S. approval in December 2025 and subsequent international expansion.

Serious adverse events affected 5.6% of MYQORZO patients versus 9.3% on placebo, while the Canadian label requires heart monitoring because of heart failure risk.

Cytokinetics expects Canadian approval to support future patient access and commercial expansion; following the announcement.

The Canadian product monograph includes a boxed warning because MYQORZO can reduce left ventricular ejection fraction, requiring echocardiograms before and during treatment.

Cytokinetics launched MYQORZO in Germany in June 2026, reported $25 million in second-quarter product revenue and continues investigating aficamten for non-obstructive hypertrophic cardiomyopathy.