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Ascendis (ASND) Seeks FDA Nod for New Immunotherapy Study
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Ascendis Pharma A/S (ASND - Free Report) announced that it has submitted an investigational new drug application (IND) with the FDA seeking approval to initiate a phase I/II study — IL βelieγe — to evaluate its long-acting pipeline candidate, TransCon IL-2 β/γ, in patients with advanced cancer.
The company has designed a novel parent drug and combined it with its clinically validated TransCon platform to create TransCon IL-2 β/γ. The candidate is believed to overcome the shortcomings of IL-2 based immunotherapies for cancer patients, which include low potency, short half-life and, high Cmax (highest concentration of a drug in the body). The design of this investigational long-acting prodrug is likely to improve cancer immunotherapy through the sustained systemic release of an IL-2 variant. Please note that IL-2 activates the immune system and blocks the reproduction and spread of cancer cells, per a Melanoma Research Alliance article.
Apart from TransCon IL-2 β/γ, the company is developing another pipeline candidate, TransCon TLR7/8 Agonist as a monotherapy and in combination with a checkpoint inhibitor, Merck’s (MRK - Free Report) Keytruda, in a phase I/II study as a potential treatment for patients with advanced or metastatic solid tumors.
Shares of Ascendis have declined 1.6% so far this year against the industry’s increase of 2.8%.
Image Source: Zacks Investment Research
The company’s drug or leading pipeline candidates target endocrinology rare diseases. Last month, it received the first FDA approval for any candidate in its pipeline. The FDA approved a biologics license application (BLA) for Skytrofa (TransConhGH; lonapegsomatropin-tcgd) as a long-acting growth hormone treatment drug for growth failure in pediatric patients. The drug has the potential to replace the current standard of care of daily somatropin therapies, which includes Pfizer’s (PFE - Free Report) Genotropin, due to its once-weekly administration. This field is dominated by Eli Lilly (LLY - Free Report) , Novo Nordisk, Pfizer, Sandoz, Merck KGaA, and Roche
A regulatory application seeking approval for lonapegsomatropin for pediatric growth hormone deficiency is under review in Europe. A decision is expected in the fourth quarter of 2021.
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. Top-line data from the late-stage study is expected in the fourth quarter of 2021.
Image: Bigstock
Ascendis (ASND) Seeks FDA Nod for New Immunotherapy Study
Ascendis Pharma A/S (ASND - Free Report) announced that it has submitted an investigational new drug application (IND) with the FDA seeking approval to initiate a phase I/II study — IL βelieγe — to evaluate its long-acting pipeline candidate, TransCon IL-2 β/γ, in patients with advanced cancer.
The company has designed a novel parent drug and combined it with its clinically validated TransCon platform to create TransCon IL-2 β/γ. The candidate is believed to overcome the shortcomings of IL-2 based immunotherapies for cancer patients, which include low potency, short half-life and, high Cmax (highest concentration of a drug in the body). The design of this investigational long-acting prodrug is likely to improve cancer immunotherapy through the sustained systemic release of an IL-2 variant. Please note that IL-2 activates the immune system and blocks the reproduction and spread of cancer cells, per a Melanoma Research Alliance article.
Apart from TransCon IL-2 β/γ, the company is developing another pipeline candidate, TransCon TLR7/8 Agonist as a monotherapy and in combination with a checkpoint inhibitor, Merck’s (MRK - Free Report) Keytruda, in a phase I/II study as a potential treatment for patients with advanced or metastatic solid tumors.
Shares of Ascendis have declined 1.6% so far this year against the industry’s increase of 2.8%.
Image Source: Zacks Investment Research
The company’s drug or leading pipeline candidates target endocrinology rare diseases. Last month, it received the first FDA approval for any candidate in its pipeline. The FDA approved a biologics license application (BLA) for Skytrofa (TransConhGH; lonapegsomatropin-tcgd) as a long-acting growth hormone treatment drug for growth failure in pediatric patients. The drug has the potential to replace the current standard of care of daily somatropin therapies, which includes Pfizer’s (PFE - Free Report) Genotropin, due to its once-weekly administration. This field is dominated by Eli Lilly (LLY - Free Report) , Novo Nordisk, Pfizer, Sandoz, Merck KGaA, and Roche
A regulatory application seeking approval for lonapegsomatropin for pediatric growth hormone deficiency is under review in Europe. A decision is expected in the fourth quarter of 2021.
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. Top-line data from the late-stage study is expected in the fourth quarter of 2021.
Ascendis Pharma AS Price
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Zacks Rank
Ascendis currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.