Cytokinetics: FDA To Review NDA For Aficamten - Quick Facts

(RTTNews) - Cytokinetics (CYTK) announced the FDA has accepted the companys New Drug Application for aficamten for the treatment of obstructive hypertrophic cardiomyopathy. The FDA assigned the NDA a standard review with a PDUFA target action date of September 26, 2025. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss the application.

The FDA previously granted aficamten Orphan Drug Designation for the treatment of symptomatic HCM in January 2021 and Breakthrough Therapy Designation for the treatment of obstructive HCM in December 2021.

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