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 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.
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