and efficacy of once-weekly TransCon hGH (lonapegsomatropin; approved for pediatric growth hormone deficiency) compared to daily somatropin in prepubertal children with Turner syndrome.

The FDA has accepted Ascendis Pharma's supplemental Biologics License Application for TransCon hGH in adult growth hormone deficiency, marking a significant step toward expanding its market and ...

Ascendis Pharma (ASND) said the FDA has accepted for its supplemental Biologics License Application for TransCon hGH for the treatment of adult growth hormone deficiency, or GHD. The agency has ...

The sBLA submission is based on results from foresiGHt, a phase 3 randomized, parallel-arm, placebo-controlled (double-blind) and active-controlled (open-label) trial that compared the efficacy and ...

in adult growth hormone deficiency (GHD) for TransCon hGH (lonapegsomatropin-tcgd; marketed as SKYTROFA ® for pediatric GHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of ...

At the heart of the agreement is an exclusive worldwide license to Copenhagen-based Ascendis' TransCon technology ... a long-acting growth hormone for children with growth hormone deficiency.

“Our expanding TransCon technology platform and partnerships ... BLA for SKYTROFA for the treatment of adults with growth hormone deficiency and Ascendis’ plans for a U.S. commercial launch ...

TransCon CNP (navepegritide ... date of the supplemental BLA for SKYTROFA for the treatment of adults with growth hormone deficiency and Ascendis' plans for a U.S. commercial launch, if approved ...

“Ascendis is well-positioned for rapid revenue growth with ... First planned TransCon protein degrader product candidate designed to normalize excess FGF-23 hormone levels for patients with ...