Cytokinetics (CYTK) announced that the U.S. Food & Drug Administration has accepted the company’s New Drug Application for aficamten, a next-in-class cardiac myosin inhibitor, for the treatment of obstructive hypertrophic cardiomyopathy. The FDA assigned the NDA a standard review with a Prescription Drug User Fee Act target action date of September 26, 2025. The FDA is not currently planning to hold an advisory committee meeting to discuss the application.
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