We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Ascendis (ASND) Gets Positive CHMP Opinion for GHD Drug Filing
Read MoreHide Full Article
Ascendis Pharma A/S (ASND - Free Report) announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion and recommended marketing authorization of TransConhGH (Lonapegsomatropin Ascendis Pharma) for the treatment of pediatric growth hormone deficiency (“GHD”). TransCon hGH 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 positive CHMP opinion for Ascendis’ TransCon hGH was based on encouraging data from three late-stage studies — heiGHt, fliGHt and enliGHten, which evaluated the candidate in more than 300 pediatric patients with GHD. A decision from the EMA related to the approval for the candidate in Europe is expected by the end of January.
In August, Ascendis’ TransCon hGH was approved by the FDA as a treatment for growth failure due to inadequate secretion of endogenous growth hormone (“GH”) in pediatric patients 1 year or older and who weigh at least 11.5 kg, with the tradename of Skytrofa. The drug has the potential to replace the current standard-of-care of daily somatropin therapies, including Pfizer’s (PFE - Free Report) Genotropin, due to its once-weekly administration.
Shares of Ascendis have declined 6.6% so far this year compared with the industry’s decrease of 13.9%.
Image Source: Zacks Investment Research
Pfizer’s Genotropin generated $284 million in the first nine months of 2021. However, the sales of Pfizer’s drug were down 10.1% year over year. A generic version of Pfizer’s GHD drug has been available since 2008.
Pfizer is currently seeking approval for a new GHD candidate, somatrogon, in the United States, Europe and Japan. Potential approvals in these countries or regions are expected next year.
Novo Nordisk (NVO - Free Report) is another company with an FDA-approved, once-weekly treatment for GHD.
Novo Nordisk’s Sogroya was approved in the United States for adults with GHD last year. Novo Nordisk’s GHD drug also received approval in Europe earlier this year. However, Novo Nordisk is yet to report any sales of the drug so far.
I-Mab Biopharma (IMAB - Free Report) is a small biotech that is also developing its pipeline candidate, eftansomatropin alfa, for treating pediatric GHD.
I-Mab is currently evaluating the candidate in a phase III study. Earlier this month, I-Mab also inked an agreement with Jumpcan Pharmaceutical Group for the development and commercialization of the candidate in mainland China.
Image: Bigstock
Ascendis (ASND) Gets Positive CHMP Opinion for GHD Drug Filing
Ascendis Pharma A/S (ASND - Free Report) announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion and recommended marketing authorization of TransConhGH (Lonapegsomatropin Ascendis Pharma) for the treatment of pediatric growth hormone deficiency (“GHD”). TransCon hGH 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 positive CHMP opinion for Ascendis’ TransCon hGH was based on encouraging data from three late-stage studies — heiGHt, fliGHt and enliGHten, which evaluated the candidate in more than 300 pediatric patients with GHD. A decision from the EMA related to the approval for the candidate in Europe is expected by the end of January.
In August, Ascendis’ TransCon hGH was approved by the FDA as a treatment for growth failure due to inadequate secretion of endogenous growth hormone (“GH”) in pediatric patients 1 year or older and who weigh at least 11.5 kg, with the tradename of Skytrofa. The drug has the potential to replace the current standard-of-care of daily somatropin therapies, including Pfizer’s (PFE - Free Report) Genotropin, due to its once-weekly administration.
Shares of Ascendis have declined 6.6% so far this year compared with the industry’s decrease of 13.9%.
Image Source: Zacks Investment Research
Pfizer’s Genotropin generated $284 million in the first nine months of 2021. However, the sales of Pfizer’s drug were down 10.1% year over year. A generic version of Pfizer’s GHD drug has been available since 2008.
Pfizer is currently seeking approval for a new GHD candidate, somatrogon, in the United States, Europe and Japan. Potential approvals in these countries or regions are expected next year.
Novo Nordisk (NVO - Free Report) is another company with an FDA-approved, once-weekly treatment for GHD.
Novo Nordisk’s Sogroya was approved in the United States for adults with GHD last year. Novo Nordisk’s GHD drug also received approval in Europe earlier this year. However, Novo Nordisk is yet to report any sales of the drug so far.
I-Mab Biopharma (IMAB - Free Report) is a small biotech that is also developing its pipeline candidate, eftansomatropin alfa, for treating pediatric GHD.
I-Mab is currently evaluating the candidate in a phase III study. Earlier this month, I-Mab also inked an agreement with Jumpcan Pharmaceutical Group for the development and commercialization of the candidate in mainland China.
Ascendis Pharma AS Price
Ascendis Pharma AS price | Ascendis Pharma AS Quote
Zacks Rank
Ascendis currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.