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Ascendis' (ASND) TransCon hGH Gets EU Nod for Pediatric GHD

Ascendis Pharma A/S ASND announced that the European Commission has granted marketing authorization to TransCon hGH (Lonapegsomatropin Ascendis Pharma) for the treatment of growth hormone deficiency (“GHD”) in children and adolescents aged between three to 18 years. TransCon hGH is a long-acting, once-weekly prodrug of somatropin (human growth hormone or hGH) for addressing pediatric patients with GHD.

The approval in Europe was based on data from three late-stage studies — heiGHt, fliGHt and enliGHten, which evaluated TransCon hGH in more than 300 pediatric patients with GHD.

The approval in Europe was expected, as in November 2021, the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) rendered a positive opinion on and recommended marketing authorization of TransCon hGH for treating pediatric GHD.

Pediatric GHD, a serious disease that affects orphans, is caused as a result of the pituitary gland’s inability to produce required amounts of growth hormone.

Shares of Ascendis have declined 24.6% in the past year compared with the industry’s decrease of 32.4%.

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In August 2021, the FDA approved TransCon hGH (under the trade name of Skytrofa) as a treatment for growth failure due to inadequate secretion of endogenous growth hormone in pediatric patients aged one year or above and who weigh at least 11.5 kg. The drug has the potential to replace the current standard-of-care of daily somatropin therapies, including Pfizer’s PFE Genotropin, due to its once-weekly administration.

Pfizer’s Genotropin generated $284 million in the first nine months of 2021. However, sales of the drug were down 10.1% year over year. A generic version of Pfizer’s GHD drug is also available.

Several other large as well as small pharmaceutical companies are also engaged in developing treatments for GHD, including Eli Lilly, Novo Nordisk, Pfizer, Sandoz, Merck KGaA, and Roche.

Ascendis is evaluating multiple other pipeline candidates developed using TransCon. Key among them are TransCon CNP and TransCon PTH. A phase II study is evaluating TransCon CNP for the treatment of achondroplasia, the most common form of dwarfism. TransCon PTH is being evaluated in a phase III study as a potential treatment for hypoparathyroidism in adult patients.

Zacks Rank & Other Stocks to Consider

Ascendis currently carries a Zacks Rank #2 (Buy). Top-ranked stocks in the biotech sector include Precision BioSciences, Inc. DTIL and AnaptysBio, Inc. ANAB, both sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Precision BioSciences’ loss per share estimates have narrowed 6.3% for 2022, over the past 60 days.

Precision BioSciences’ earnings surpassed estimates in each of the trailing four quarters.

AnaptysBio’s loss per share estimates have narrowed 0.3% for 2022, over the past 60 days. The stock has rallied 25.4% in the past year.

AnaptysBio’s earnings surpassed estimates in three of the trailing four quarters and missed the same on the other occasion.

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