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.
Amryt (AMYT) NDA for Skin Disorder Drug Gets Priority Review
Read MoreHide Full Article
Amryt Pharma plc announced that the FDA has accepted the new drug application (“NDA”) for its lead pipeline candidate, Oleogel-S10, and granted priority review. The NDA is seeking approval for the candidate as a treatment for cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB), a rare and distressing genetic skin disorder. The FDA is expected to provide a decision related to the approval of the NDA by Nov 30, 2021.
Please note that the candidate will be available with the trade name of Filsuvez, following a potential approval.
Shares of Amryt were up 1.7% on Jun 3, following the news. However, the company’s shares have declined 16.1% so far this year compared with the industry’s 4.3% decrease.
Image Source: Zacks Investment Research
The company previously reported positive top-line data from the phase III EASE study, evaluating Oleogel-S10 in patients with EB last year. Data from the study demonstrated that treatment with the candidate achieved statistically significant increase in speed of wound healing. The study evaluated the candidate in EB patients with target wounds between 10 and 50 square centimeter in size, which were present for more than 21 days and less than nine months. Oleogel-S10 achieved complete closure of the target wound within 45 days of treatment, the study’s primary endpoint, in statistically significant proportion of patients compared to standard of care.
Amryt stated that it estimates the EB indication has a global market of more than $1 billion. With no FDA-approved treatment this may provide a significant opportunity for the candidate, following a potential approval in the United States.
Meanwhile, an investigator-led phase II study to evaluate Oleogel-S10 in patients with severe radiation-induced dermatitis has been planned to start later in 2021.
The company has two marketed drugs — Myalept and Juxtapid — in its portfolio that are approved to treat leptin deficiency in patients with congenital or acquired generalized lipodystrophy, and homozygous familial hypercholesterolaemia, respectively. These drugs generated more than $180 million in 2020. A potential approval to Oleogel-S10 for EB patients will likely boost revenues further.
Xencor’s loss per share estimates have narrowed 34% for 2021 over the past 30 days.
Organogenesis’ earnings per share estimates have increased 200% for 2021 over the past 30 days. The stock has jumped 136.8% so far this year.
Adaptive’s loss per share estimates have narrowed 13.4% for 2021 over the past 30 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Amryt (AMYT) NDA for Skin Disorder Drug Gets Priority Review
Amryt Pharma plc announced that the FDA has accepted the new drug application (“NDA”) for its lead pipeline candidate, Oleogel-S10, and granted priority review. The NDA is seeking approval for the candidate as a treatment for cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (EB), a rare and distressing genetic skin disorder. The FDA is expected to provide a decision related to the approval of the NDA by Nov 30, 2021.
Please note that the candidate will be available with the trade name of Filsuvez, following a potential approval.
Shares of Amryt were up 1.7% on Jun 3, following the news. However, the company’s shares have declined 16.1% so far this year compared with the industry’s 4.3% decrease.
Image Source: Zacks Investment Research
The company previously reported positive top-line data from the phase III EASE study, evaluating Oleogel-S10 in patients with EB last year. Data from the study demonstrated that treatment with the candidate achieved statistically significant increase in speed of wound healing. The study evaluated the candidate in EB patients with target wounds between 10 and 50 square centimeter in size, which were present for more than 21 days and less than nine months. Oleogel-S10 achieved complete closure of the target wound within 45 days of treatment, the study’s primary endpoint, in statistically significant proportion of patients compared to standard of care.
Amryt stated that it estimates the EB indication has a global market of more than $1 billion. With no FDA-approved treatment this may provide a significant opportunity for the candidate, following a potential approval in the United States.
Meanwhile, an investigator-led phase II study to evaluate Oleogel-S10 in patients with severe radiation-induced dermatitis has been planned to start later in 2021.
The company has two marketed drugs — Myalept and Juxtapid — in its portfolio that are approved to treat leptin deficiency in patients with congenital or acquired generalized lipodystrophy, and homozygous familial hypercholesterolaemia, respectively. These drugs generated more than $180 million in 2020. A potential approval to Oleogel-S10 for EB patients will likely boost revenues further.
Amryt Pharma PLC Sponsored ADR Price
Amryt Pharma PLC Sponsored ADR price | Amryt Pharma PLC Sponsored ADR Quote
Zacks Rank & Stocks to Consider
Amryt currently carries a Zacks Rank #3 (Hold). Some better-ranked medical stocks include Xencor, Inc. (XNCR - Free Report) , Organogenesis Holdings Inc. (ORGO - Free Report) and Adaptive Biotechnologies (ADPT - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Xencor’s loss per share estimates have narrowed 34% for 2021 over the past 30 days.
Organogenesis’ earnings per share estimates have increased 200% for 2021 over the past 30 days. The stock has jumped 136.8% so far this year.
Adaptive’s loss per share estimates have narrowed 13.4% for 2021 over the past 30 days.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>