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FDA Pushes Review Date For Ascendis Pharma's Hormone Disorder Candidate By Three Months

Tuesday, Ascendis Pharma A/S (NASDAQ:ASND) announced that the FDA extended the review date for TransCon PTH (palopegteriparatide) for adults with hypoparathyroidism. Hypoparathyroidism is an uncommon condition in which the body produces abnormally low levels of parathyroid hormone (PTH).  The low production of PTH in hypoparathyroidism leads to abnormally low calcium levels in the blood and an increase of phosphorus in the blood. The agency said the information Ascendis Pharma submitted in response to the FDA’s ongoing review of the New Drug Application (NDA) for TransCon PTH constituted a major amendment to the NDA.  Accordingly, the ...