FDA Delays Decision on Ascendis' (ASND) Hormone Therapy Filing
ASNDAscendis Pharma(ASND) Zacks Investment Research·2024-05-15 23:46

Shares of Ascendis Pharma (ASND) lost more than 5% on Tuesday after management announced that the FDA extended the review period for its regulatory filing for a hormone replacement therapy by an additional three months. A final decision is now expected by Aug 14, 2024. The company’s filing seeks approval for TransCon PTH (palopegteriparatide) to treat adults with hypoparathyroidism, a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone ...