Cytokinetics Wins FDA Nod For Heart Drug Myqorzo

Core Viewpoint - The FDA has approved Cytokinetics Incorporated's Myqorzo (aficamten) for treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aimed at improving functional capacity and symptoms [1] Group 1: Drug Approval and Mechanism - Myqorzo is an allosteric and reversible inhibitor of cardiac myosin motor activity, which reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in oHCM patients [1] - The full U.S. Prescribing Information for Myqorzo includes a Boxed WARNING for the risk of heart failure [2] Group 2: Clinical Data - The approval is based on positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, which demonstrated robust efficacy, safety, and clinically meaningful benefits across various endpoints [5] - Treatment with Myqorzo for 24 weeks significantly improved exercise capacity, increasing peak oxygen uptake (pVO2) by 1.8 mL/kg/min compared to baseline, while placebo showed no improvement [6] Group 3: Market Reaction - Wall Street has reacted positively to Cytokinetics, with multiple firms raising their price forecasts; HC Wainwright increased its forecast to $136 from $120, and Needham raised it to $84 from $72 [7] - Cytokinetics shares rose 11.70% to $70.02, reaching a new 52-week high [8]