Why Ascendis Pharma Stock Is Crashing This Week
Shares of Ascendis Pharma (NASDAQ: ASND) were crashing 32% lower this week as of the market close on Thursday, according to data provided by S&P Global Market Intelligence. The steep decline came after Ascendis announced on Monday that the U.S. Food and Drug Administration (FDA) identified deficiencies in the company's New Drug Application (NDA) for TransCon PTH in treating hypoparathyroidism.
The FDA didn't reveal exactly what deficiencies it found with Ascendis' NDA filing for TransCon PTH. However, the agency stated that it hasn't made a final decision on the application for the experimental drug. TransCon PTH's PDUFA date is currently set for April 30, 2023. Ascendis Pharma CEO Jan Mikkelsen acknowledged that this date could be pushed back.
Mikkelsen said in a press release that Ascendis will continue giving TransCon PTH to patients enrolled in ongoing clinical studies. He also noted that there haven't been any new safety issues identified with the drug in those trials.
Source Fool.com
