Cytokinetics Wins FDA Nod For Heart Drug Myqorzo

On Friday, the U.S. Food and Drug Administration (FDA) approved Cytokinetics Incorporated’s (NASDAQ:CYTK) Myqorzo (aficamten) for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.

Myqorzo is an 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.

The full U.S. Prescribing Information for Myqorzo includes a Boxed WARNING for the risk of heart failure.

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Myqorzo reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Systolic dysfunction means the heart’s main pumping chamber (left ventricle) is weak and can’t contract properly, failing to pump enough oxygen-rich blood to the body.

Echocardiogram assessments are required before and during treatment with Myqorzo to monitor for systolic dysfunction.

Myqorzo is expected to be available in the U.S. in the second half of January 2026.

Clinical Data Supporting Approval

The approval is based on the positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine, which demonstrated robust efficacy, safety, and clinically meaningful benefits across symptoms, exercise capacity, hemodynamics, and biomarker endpoints.

The results from SEQUOIA-HCM showed that treatment with Myqorzo for 24 weeks significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by 1.8 mL/kg/min compared to baseline in patients treated with Myqorzo versus 0.0 mL/kg/min in patients treated with placebo.

Street Reaction

Wall Street struck a broadly bullish tone on Cytokinetics, with multiple firms reiterating positive ratings and raising their price forecasts. HC Wainwright maintained a Buy and raised its price forecast to $136 from $120.

Needham reaffirmed a Buy and lifted its price forecast to $84 from $72. Citizens maintained a Market Outperform and increased its price forecast to $88 from $78.

Barclays reiterated an Overweight rating and raised its price forecast to $87 from $82, while RBC Capital maintained an Outperform and lifted its price forecast to $95 from $87.

CYTK Price Action: Cytokinetics shares were up 11.70% at $70.02 at the time of publication on Monday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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