Ascendis Pharma Announces Extension of U.S. Food and Drug Administration Review Period for TransCon™ PTH for Adults with Hypoparathyroidism

May 14, 2024

https://www.globenewswire.com/news-release/2024/05/14/2881783/0/en/Ascendis-Pharma-Announces-Extension-of-U-S-Food-and-Drug-Administration-Review-Period-for-TransCon-PTH-for-Adults-with-Hypoparathyroidism.html

– Prescription Drug User Fee Act (PDUFA) goal date extended by three months for further review of submission to August 14, 2024

COPENHAGEN, Denmark, May 14, 2024 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq:ASND) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that information submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism constituted a major amendment to the NDA. Accordingly, the FDA has extended the PDUFA target action date by three months, to August 14, 2024, to provide time for a full review of the submission.

Read more at globenewswire.com

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