Ascendis Pharma (ASND) said its supplemental biologics license application for TransCon hGH as therapy for adult growth hormone deficiency was accepted for review by the US Food and Drug Administration.
The FDA has set a July 27 review deadline, the company said Thursday in a statement.
The supplemental application is based on the results of a phase 3 trial that evaluated 259 adults with growth hormone deficiency, and TransCon hGH was found to be "generally safe and well tolerated," Ascendis said.
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