Ascendis Pharma A/S Announces U.S. Food and Drug Administration Notifies Information Submitted in Connection with the FDA's Ongoing Review of the Biologics License Application for Lonapegsomatropin

On June 11, 2021, the U.S. Food and Drug Administration (FDA) notified Ascendis Pharma A/S (company) that information the Company submitted in connection with the FDA’s ongoing review of the Biologics License Application (BLA) for lonapegsomatropin for the treatment of pediatric growth hormone deficiency constituted a major amendment to the BLA. Accordingly, the FDA has extended the Prescription Drug User Fee Act goal date by three months, to September 25, 2021.