Why Ascendis Pharma (ASND) Shares Are Diving Today - Ascendis Pharma (NASDAQ:ASND)

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Ascendis Pharma A/S' ASND stock is down 28% Monday morning as the FDA has notified deficiencies in its marketing application for TransCon PTH (palopegteriparatide) in hypoparathyroidism.
The deficiencies were not disclosed in the letter. The FDA also stated that this does not reflect their final regulatory decision on the company's application.
"This development a month from the agency's PDUFA action date may lead to a delay in the FDA's final regulatory decision on the TransCon PTH NDA," said Jan Mikkelsen, Ascendis Pharma's President and Chief Executive Officer.
To date, 145 out of 154 clinical trial participants continue to be treated with TransCon PTH in Phase 2 and Phase 3 clinical trial open-label extensions.
TransCon PTH has been generally well tolerated, with no discontinuations related to the study drug, the company said.
As expected, Ascendis has received the comprehensive Day 120 response from the European Medicines Agency in Europe.
The Copenhagen, Denmark-based company remains on track for a European Commission decision on the Marketing Authorisation Application for TransCon PTH during the fourth quarter of 2023.
If approved, Ascendis expects its first European country launch in early 2024.
Price Action: ASND shares are down 27.93% at $77.27 on the last check Monday.

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Ascendis Pharma Flags Regulatory Delay In US For Its Hypoparathyroidism Candidate