FDA Extends Review of Ascendis Pharma’s TransCon CNP NDA to February 2026

Reuters11-26
FDA Extends Review of Ascendis Pharma's TransCon CNP NDA to February 2026

Ascendis Pharma A/S announced that the U.S. Food and Drug Administration (FDA) has designated information submitted on November 5, 2025, regarding a post-marketing requirement for the New Drug Application (NDA) for TransCon CNP (navepegritide) for children with achondroplasia as a major amendment. As a result, the FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date by three months, with a new decision date set for February 28, 2026.

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