Ascendis: FDA Accepts for Review Resubmitted NDA for TransCon PTH

 Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act (PDUFA) goal date of May 14, 2024. In the United States, TransCon PTH (palopegteriparatide) is an investigational prodrug of parathyroid hormone (PTH [1-34]) for adult patients with hypoparathyroidism.

https://www.globenewswire.com/news-release/2023/12/11/2793855/0/en/FDA-Accepts-for-Review-Resubmitted-NDA-for-TransCon-PTH-Palopegteriparatide-in-Adult-Patients-with-Hypoparathyroidism.html