FDA accepts Ascendis Pharma’s NDA for TransCon CNP for priority review

The company states: “Ascendis Pharma (ASND) A/S announced that the FDA has accepted for priority review its New Drug Application, NDA, for TransCon CNP for the treatment of children with achondroplasia and has set a Prescription Drug User Fee Act goal date of November 30, 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. TransCon CNP is an investigational prodrug of C-type natriuretic peptide administered once weekly and designed to treat people living with achondroplasia by providing continuous exposure of active CNP to receptors on tissues throughout the body, including growth plates and skeletal muscle.”