FDA accepts for filing Biologics License Application for long-acting human growth hormone, somatrogon, for treatment of children with growth hormone deficiency

Submission is based on positive data from phase III trial in children treated with once-weekly somatrogon, which met primary endpoint of non-inferiority to daily injections of somatropin, as assessed by annual height velocity at 1 year (10.12 vs 9.78 cm/year, respectively).

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Biospace Inc.