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# FDA Extends Review of TransCon CNP for Achondroplasia
- URL: https://www.fdaweb.com/fda-extends-review-of-transcon-cnp-for-achondroplasia/
- Published: 2025-11-26T12:00:00.000Z
- Updated: 2026-09-14T15:27:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160288

FDA has extended by three months its review of an Ascendis Pharma NDA for TransCon CNP (navepegritide) and its use for treating children with achondroplasia. The agency told the drugmaker that additional information Ascendis submitted earlier this month, including a revised protocol for a required post-marketing study, constituted a “major amendment” to the ongoing NDA review, according to the company. The revised user fee review action target date is 2/28/2026.

Ascendis says TransCon CNP is designed to treat achondroplasia, the most common form of dwarfism, by providing sustained release of C-type natriuretic peptide.