Ascendis Pharma A/S (NASDAQ:ASND) submits a Biologics License Application to the FDA for TransCon hGH (lonapegsomatropin), a long-acting once-weekly prodrug of somatropin (human growth hormone or hGH) for the treatment for pediatric growth hormone deficiency (GHD).
Currently, there is no approved long-acting growth hormone treatment in the U.S. or Europe.
The company plans to submit a marketing authorisation application for TransCon hGH in Europe in Q3 and to initiate a Phase 3 trial in pediatric GHD in Japan in Q4.
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