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Ascendis Submits BLA to FDA for TransConhGH in Pediatric GHD

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Ascendis Pharma A/S ((ASND - Free Report) ) announced that it has submitted a Biologics License Application (BLA) to the FDA for TransConhGH (lonapegsomatropin), for the treatment ofpediatric growth hormone deficiency (GHD). TransConhGH is a long-acting, once-weekly prodrug of somatropin (human growth hormone or hGH).

Pediatric GHD is a serious orphan disease, which is caused when the pituitary gland does not produce enough growth hormone.

The TransCon platform is an innovative technology designed to create new therapies that optimize therapeutic effect, including efficacy, safety and dosing frequency. The company believes that the TransContechnology has the potential to address major unmet medical needs. TransConhGH is designed to maintain the same mode of action as daily hGH therapies by releasing the same growth hormone molecule, somatropin. Currently, there is no approved long-acting growth hormone treatment in the United States or Europe. TransConhGH has Orphan Drug designation for GHD in both the United States and Europe.

A potential approval of TransConhGH will enable the company to address the large unmet need and be a potential new treatment option forchildren with GHD.

Ascendis Pharma plans to submit a Marketing Authorization Application (MAA) for TransConhGH to the European Medicines Agency in the third quarter for pediatric GHD.  The company also plans to initiate a phase III study with TransConhGH in pediatric GHD in Japan in the fourth quarter and a phase III study is ongoing in Greater China.

Shares of Ascendis have increased 6.4% year to date compared with the industry’s growth of 10.8%.

Ascendis Pharma is applying its innovative platform technology to build a leading, fully integrated biopharma company which aims at making a meaningful difference in patients’ lives.

Zacks Rank &Stocks to Consider

Ascendis currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Applied Therapeutics Inc. (APLT - Free Report) , Emergent Biosolutions Inc. (EBS - Free Report) and Ligand Pharmaceuticals Inc. (LGND - Free Report) , all carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Applied Therapeutics’ loss per share estimates have narrowed from $3.02 to $2.73 for 2020 and from $3.41 to $3.28 for 2021 in the past 60 days.

Emergent’s earnings per share estimates have increased from $3.43 to $4.03 for 2020 and from $3.54 to $3.73 for 2021 in the past 60 days.

Ligand Pharmaceuticals’ earnings per share estimates have increased from $3.45 to $3.70 for 2020 and from $4.00 to $4.40 for 2021 in the past 60 days.

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