Ascendis Pharma A/S (ASND) Monday said it has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food & Drug Administration (FDA) for TransCon hGH to treat adults with growth hormone deficiency.
TransCon hGH is marketed as Skytrofa in the U.S. for pediatric growth hormone deficiency.
The submission is based on positive results from foresiGHt, a Phase 3 study that compared the efficacy and safety of TransCon hGH in adults with growth hormone deficiency.
TransCon hGH demonstrated superiority on its primary efficacy and key secondary efficacy endpoints at Week 38, with TransCon hGH-treated patients showing a statistically significant reduction from baseline in trunk fat and increase in total body lean mass at Week 38 compared to placebo, the company said in a statement.
For comments and feedback contact: editorial@rttnews.com
Business News
May 08, 2026 15:50 ET Manufacturing and services sector survey results and labor market data from main economies were the highlight on the economics news front this week. Factory orders and jobs report dominated the news flow in the U.S. Similarly, industrial production data from German garnered attention in Europe. In Asia, purchasing managers’ survey results from China and the central bank decision from Australia were in focus.