FX.co ★ Cytokinetics: FDA To Review NDA For Aficamten - Quick Facts

Cytokinetics (CYTK) has announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for aficamten, intended for the treatment of obstructive hypertrophic cardiomyopathy (HCM). The FDA has assigned a standard review timeline, marking the Prescription Drug User Fee Act (PDUFA) target action date as September 26, 2025. It is notable that the FDA currently does not plan to convene an advisory committee meeting to deliberate on this application.

Previously, in January 2021, the FDA awarded aficamten Orphan Drug Designation for treating symptomatic HCM. Furthermore, in December 2021, the drug received Breakthrough Therapy Designation specifically for obstructive HCM, highlighting its potential significance in addressing this medical condition.