Ascendis Pharma Shares Drop 30% After FDA Identifies Deficiencies in TransCon PTH's New Drug App

By Chris Wack

Ascendis Pharma A/S shares were down 30% at $74.95 Monday after the company said the U.S. Food & Drug Administration found deficiencies in the company's new drug application for TransCon PTH, its candidate for the treatment of hypoparathyroidism.

The stock is now down 37% over the past 12 months.

According to the Copenhagen-based biopharmaceutical company, the FDA letter didn't disclose the deficiencies and precludes them from holding further discussions about labeling and post-marketing requirements and commitments at this time. However, Ascendis said, the FDA also stated that the letter didn't reflect a final regulatory decision on the new drug application.

Ascendis said that 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. In these studies, TransCon PTH has been generally well-tolerated, with no discontinuations related to the study drug, according to Ascendis.

In December, the FDA allowed Ascendis to initiate a U.S. Expanded Access Program for TransCon PTH in eligible adults with hypoparathyroidism previously treated with parathyroid hormone. The EAP, which remains open for enrollment, gives U.S. physicians the opportunity to request access to investigational TransCon PTH for eligible patients.

In Europe, Ascendis has received a comprehensive Day-120 response from the European Medicines Agency. Ascendis said it remains on track for TransCon PTH receiving a European Commission decision on a marketing authorization application during the fourth quarter this year.

If approved, Ascendis expects TransCon PTH to see its first European country launch early next year.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

April 03, 2023 10:49 ET (14:49 GMT)

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