Benzinga | Jun 14, 2021 07:23AM EDT

Ascendis Pharma's TransCon hGH FDA Review Pushed Backed By Three Months

* The FDA has extended the ongoing review of the marketing application of Ascendis Pharma A/S's (NASDAQ:ASND) TransCon hGH (lonapegsomatropin) for the treatment of pediatric growth hormone deficiency.

* Citing a major amendment to the application, the agency has pushed the action goal date by three months to September 25.

* "We have responded to all outstanding questions from the FDA and believe the complete package we have submitted satisfies all of FDA's requests and will enable a complete review of the application of lonapegsomatropin for pediatric GHD," said Jan Mikkelsen, Ascendis Pharma's President, and CEO.

* Price Action: ASND shares closed at $130.25 on Friday.