Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia

–  Prescription Drug User Fee Act (PDUFA) goal date extended by three months to February 28, 2026

COPENHAGEN, Denmark, Nov. 25, 2025 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) notified the Company that information submitted on November 5, 2025, related to the post-marketing requirement, in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia, constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months to February 28, 2026.

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