Benzinga | Jan 13, 2022 11:53AM EST

Ascendis Pharma's Growth Hormone Deficiency Med Scores European Approval

The European Commission (EC) has granted marketing authorization to Ascendis Pharma A/S's (NASDAQ:ASND) Lonapegsomatropin (developed under the name TransCon hGH).

* The approval for TransCon covers a once-weekly subcutaneous injection for children and adolescents ages 3 to 18 years with growth failure due to growth hormone deficiency (GHD).

* TransCon hGH is a prodrug of somatropin that provides sustained release of unmodified somatropin (hGH) at predictable therapeutic levels in the body.

* The EC approval is based on clinical results from the Company's Phase 3 heiGHt, fliGHt, and enliGHten Trials, which collectively treated more than 300 pediatric patients.

* In August 2021, the FDA approved TransCon hGH to treat pediatric patients one year and older who weigh at least 11.5 kg.

* Price Action: ASND shares are up 0.80% at $122.83 during the market session on the last check Thursday.