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Ascendis Pharma Says FDA Extended Review Period for TransCon CNP in Children With Achondroplasia by Three Months
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Ascendis Pharma Says FDA Extended Review Period for TransCon CNP in Children With Achondroplasia by Three Months
Nov 26, 2025 2:50 AM

05:27 AM EST, 11/26/2025 (MT Newswires) -- Ascendis Pharma ( ASND ) said late Tuesday that the US Food & Drug Administration has extended the review period for its TransCon CNP drug candidate to treat children with achondroplasia, which causes dwarfism, by three months to Feb. 28, 2026.

The FDA notified the company that its submission related to post-marketing requirements constituted a major amendment to the previously submitted new drug application, Ascendis said.

Therefore, the FDA extended the Prescription Drug User Fee Act target action date by three months, it said.

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