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INCORPORATION BY REFERENCE This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 and Form F-3 of... | May 1, 2023
The FDA has rejected a new drug application for an agent to treat adults with hypoparathyroidism due to concerns with manufacturing control strategy, according to an industry press release. The FDA issued a complete response letter for palopegteriparatide (TransCon PTH; Ascendis Pharma), an investigational parathyroid hormone prodrug for adults with hypoparathyroidism. According to the press
• Focused on bringing TransCon PTH to the U.S. and EU markets as soon as possible • 145 of 154 clinical trial participants continue treatment with TransCon PTH for up to 3 years, and U.S. Expanded Access
• Focused on bringing TransCon™ PTH to the U.S. and EU markets as soon as possible • 145 of 154 clinical trial participants continue treatment with TransCon PTH for up to 3 years,... | April 27, 2023
Press release content from Globe Newswire. The AP news staff was not involved in its creation.