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Ascendis Pharma Reports the US FDA’s Acceptance of NDA for Priority Review of TransCon PTH to Treat Hypoparathyroidism in Adult Patients

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Ascendis Pharma Reports the US FDA’s Acceptance of NDA for Priority Review of TransCon PTH to Treat Hypoparathyroidism in Adult Patients

Shots:

  • The US FDA has accepted the NDA of TransCon PTH (palopegteriparatide) for Priority Review in adult patients with hypoparathyroidism. The PDUFA date is expected on April 30, 2023
  • The company is currently planning to submit an MAA for TransCon PTH to the EMA for hypoparathyroidism in Q4’22 & the results from the P-III (PaTHway) of TransCon PTH in adult Japanese patients are also expected in Q4’22
  • TransCon PTH is an investigational prodrug & is designed to restore parathyroid hormone (PTH [1-34]) to physiological levels over 24hrs. for hypoparathyroidism. The company is expected to make TransCon PTH available shortly

Ref: Globenewswire | Image: Ascendis Pharma

Click here to­ read the full press release 

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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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