FDA Extends Review Period for TransCon CNP to February 28, 2026

Tuesday, Nov 25, 2025 6:17 pm ET1min read
ASND--

Ascendis Pharma's FDA review period for TransCon CNP (navepegritide) for children with achondroplasia has been extended by three months to February 28, 2026, due to a major amendment to the NDA. The company has responded to all outstanding requests from the FDA and is committed to working diligently to finalize elements of the post-marketing requirement. Ascendis aims to bring this innovative therapy to patients in the US as soon as possible.

FDA Extends Review Period for TransCon CNP to February 28, 2026

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