Ascendis Shares Rally Premarket as FDA Doesn't Seek New Studies

By Colin Kellaher

Shares of Ascendis Pharma AS rose sharply in premarket trading Monday after the biopharmaceutical company said the U.S. Food & Drug Administration turned away its application seeking approval of TransCon PTH for adults with hypoparathyroidism but didn't request any new studies.

Hellerup, Denmark-based Ascendis said the FDA issued a complete response letter that raised concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product.

An FDA complete response letter indicates the agency won't approve an application in its current form.

Ascendis said the FDA didn't express any concerns about the clinical data the company submitted, nor did the agency request any new preclinical studies or Phase 3 trials to evaluate safety or efficacy.

The company early last month has warned that the FDA had identified undisclosed deficiencies with the application, sending shares plummeting.

Ascendis on Monday said it believes it is well prepared to address the FDA's concerns, adding that it will request a "Type A" meeting with the agency to help determine the best path forward.

According to FDA guidelines, Type A meetings are aimed at resolving disputes and helping stalled product-development programs proceed, with scheduling targeted to occur within 30 days of receipt of a written request.

Shares of Ascendis, which closed Friday at $69.96, were recently up 17%, to $81.85, in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 01, 2023 08:01 ET (12:01 GMT)

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