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Ascendis Pharma (ASND) announced Tuesday that the U.S. Food and Drug Administration (FDA) has postponed the timeline for completing its review of the company's experimental hypoparathyroidism treatment, TransCon PTH.
The Food and Drug Administration considered the information provided by the company Regarding the New Drug Application (NDA), there was a significant amendment to the TransCon PTH NDA, which resulted in a delay.
As a result, the regulator has postponed the NDA's target action date by three months to 14 August 2024, to allow for a comprehensive review of the NDA.
In December, the US Food and Drug Administration (FDA) accepted Ascendis' NDA resubmission for TransCon PTH, an investigational parathyroid hormone (PTH(1-34)) prodrug targeting adults with hypoparathyroidism. At that time, the agency issued May 14, 2024, as the target action date.