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.
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