The U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for Ascendis Pharma’s TransCon CNP to February 28, 2026. The FDA considered information submitted on November 5, 2025, as a major amendment to the New Drug Application (NDA) for children with achondroplasia. Ascendis Pharma is committed to finalizing post-marketing requirements to bring this therapy to patients in the U.S. The company focuses on innovative therapies using the TransCon technology platform to address unmet medical needs. For more information, visit ascendispharma.com.
Read more at GlobeNewswire: Ascendis Announces Extension of FDA Review Period for
