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.
https://seekingalpha.com/news/3611741-fda-accepts-ascendis-transcon-application
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