Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
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Cytokinetics announced that the FDA has accepted its New Drug Application for aficamten, a treatment for obstructive hypertrophic cardiomyopathy. The PDUFA target action date is set for September 26, 2025.
December 02, 2024 | 12:45 pm
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Cytokinetics' NDA for aficamten has been accepted by the FDA, with a PDUFA target action date of September 26, 2025. This is a significant step for the company in treating obstructive hypertrophic cardiomyopathy.
The acceptance of the NDA by the FDA is a crucial milestone for Cytokinetics, indicating potential future revenue from aficamten if approved. The set PDUFA date provides a timeline for investors to anticipate further developments.
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