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.