Ascendis Pharma announced Monday the U.S. Food and Drug Administration identified deficiencies in the company's application for a gland treatment. Meanwhile, ASND stock plummeted on the news.
The ruling involves Ascendis' TransCon palopegteriparatide, or TransCon PTH, the company said in the news release. The drug is designed to treat hypoparathyroidism, a rare condition where parathyroid glands in the neck don't produce enough hormone.
Ascendis now is precluded from holding further discussions about labeling and post-marketing requirements and commitments by the agency.
ASND stock plunged 32.1% to close at 72.83 on the stock market today.
ASND Stock: Looking To Work With Agency
The FDA cited no specific deficiencies in its letter to the company. The FDA also stated that this move does not reflect their final regulatory decision on the application.
"We are eager to work with FDA to learn, understand and address them," Ascendis Chief Executive Jan Mikkelsen said in the news release. "This development a month from the agency's PDUFA (Prescription Drug User Fee Act) action date may lead to a delay in the FDA's final regulatory decision on the TransCon PTH new drug application."
On a more positive note, Mikkelsen said, "In Europe, our regulatory review continues as expected and we remain on track for a European Commission decision in the fourth quarter. In addition, we expect to submit an application for an EAP in Germany and open it for enrollment in the second quarter of this year."
Prior to Monday, ASND stock was down 12% for the year.
