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Amryt Pharma plc AMYT 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.
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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
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Zacks Rank & Stocks to Consider
Amryt currently carries a Zacks Rank #3 (Hold). Some better-ranked medical stocks include Xencor, Inc. XNCR, Organogenesis Holdings Inc. ORGO and Adaptive Biotechnologies ADPT, 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.
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