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FDA accepts Ascendis’ TransCon application

September 4, 2020

The FDA accepts for review Ascendis Pharma A/S’s (NASDAQ:ASND) marketing application seeking approval of TransCon hGH (lonapegsomatropin) for the treatment of pediatric growth hormone deficiency (GHD) (dwarfism), an Orphan Drug-tagged indication.

TransCon hGH is a long-acting prodrug of somatropin (human growth hormone).

The agency’s action date is June 25, 2021.

The company expects to file its application in Europe this month.

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