What happened
Shares of Ascendis Pharma (ASND -0.51%) 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.
So what
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.
Now what
Ascendis is obviously anxious to talk with the FDA to find out what the issues with the NDA filing are. The nature of the deficiencies will determine the company's next steps over the next few months.
The U.S. snag doesn't have any effect on Ascendis' European efforts to win approval for TransCon PTH. The company expects a decision from the European Medicines Agency in the fourth quarter of 2023. Assuming the drug receives a thumbs-up, Ascendis plans to launch TransCon PTH in the first European country early next year.
