2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application for TransCon CNP (navepegritide) for the treatment of children with achondroplasia and has set a PDUFA goal date of 30 November 2025 to complete its review.
The FDA also informed Ascendis that they are not currently planning to hold an advisory committee meeting to discuss this application.