FDA Accepts for Priority Review Ascendis NDA for Hypoparathyroidism

  PDUFA target action date is April 30, 2023

- MAA submission to EMA on track for this quarter

Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) in adult patients with hypoparathyroidism and has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2023. TransCon PTH is an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24 hours in adult patients with hypoparathyroidism. The FDA said that it is not currently planning to hold an advisory committee meeting to discuss the application.

https://finance.yahoo.com/news/fda-accepts-priority-review-ascendis-120000732.html