Cytokinetics Wins CHMP Backing for MYQORZO in Obstructive Hypertrophic Cardiomyopathy
Cytokinetics Incorporated has announced that the Committee for Medicinal Products for Human Use $(CHMP)$ of the European Medicines Agency $(EMA)$ has issued a positive opinion recommending marketing authorization for MYQORZO® (aficamten), a cardiac myosin inhibitor, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults. A final decision from the European Commission is expected in the first quarter of 2026. Additionally, aficamten is under regulatory review in the U.S. by the FDA, with a target action date of December 26, 2025, and is also being reviewed by the Center for Drug Evaluation $(CDE)$ of the China National Medical Products Administration (NMPA) with Priority Review status.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cytokinetics Incorporated published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9601382-en) on December 12, 2025, and is solely responsible for the information contained therein.
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