Posted by Michael Wonder on 26 Nov 2025
Ascendis announces extension of FDA review period for TransCon CNP (navepegritide) for children with achondroplasia
25 November 2025 - PDUFA goal date extended by three months to 28 February 2026.
Ascendis Pharma today announced that the US FDA notified the Company that information submitted on 5 November 2025, related to the post-marketing requirement, in response to the FDA's on-going review of the new drug application for TransCon CNP (navepegritide) for children with achondroplasia, constituted a major amendment to the NDA.
