Cytokinetics Receives CHMP's Positive Opinion On MYQORZO

(RTTNews) - Cytokinetics, Inc. (CYTK), Friday announced that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for MYQORZO, also known as aficamten, in the European Union for the patients with symptomatic obstructive hypertrophic cardiomyopathy.

The positive opinion is based on the clinical evidence from SEQUOIA-HCM, which demonstrated the safety and efficacy of MYQORZO in the participants.

The company expects the final decision from the European Commission in the first quarter of 2026.

Meanwhile, the Food & Drug Administration is reviewing a New Drug Application for aficamten with a Prescription Drug User Fee Act target action date of December 26, 2025.

Currently, CYTK is trading at $61.97, up 1.98 percent on the Nasdaq.