FDA Approves Cytokinetics' MYQORZO For Treatment Of Obstructive Hypertrophic Cardiomyopathy

(RTTNews) - Cytokinetics, Inc. (CYTK) announced that the U.S. Food and Drug Administration has approved MYQORZO (aficamten) tablets in 5 mg, 10 mg, 15 mg, and 20 mg strengths for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The therapy is indicated to improve functional capacity and symptoms in patients living with this condition. MYQORZO is an allosteric and reversible inhibitor of cardiac myosin motor activity. By inhibiting myosin, MYQORZO reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in patients with oHCM.

The full U.S. Prescribing Information for MYQORZO includes a Boxed WARNING regarding the risk of heart failure. MYQORZO can reduce left ventricular ejection fraction (LVEF) and may cause heart failure due to systolic dysfunction. Echocardiogram assessments are required before and during treatment to monitor for systolic dysfunction. Initiation of MYQORZO is not recommended in patients with LVEF below 55%. Dose adjustments are required if LVEF falls below 50% and remains at or above 40%. Treatment should be interrupted if LVEF drops below 40% or if patients experience heart failure symptoms or worsening clinical status.

Because of the risk of heart failure due to systolic dysfunction, MYQORZO will be available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS), known as the MYQORZO REMS Program.

MYQORZO is expected to become available in the United States in the second half of January 2026.

CYTK closed trading on Friday, at $62.72, reflecting a gain of $0.52 or 0.84% during regular market hours. In after-hours trading, the stock moved lower to $62.05, down $0.67 or 1.06%.

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