Amryt Pharma ( AMYT Quick Quote AMYT - Free Report) announced that the FDA has extended the review period of its new drug application (“NDA”) for its genetic skin disorder candidate, Oleogel-S10, by three months. The review date was extended for review of additional analyses of data submitted by the company following FDA acceptance of the NDA. A decision on the potential approval of Oleogel-S10 is now expected by Feb 28, 2022.
The NDA is seeking approval of the company’s lead pipeline candidate as a potential treatment for the cutaneous manifestations of junctional and dystrophic epidermolysis bullosa (“EB”). There is no FDA-approved drug available for this rare disease, which affects children as well as adults.
Amryt’s NDA for Oleogel-S10 was accepted and granted priority review by the FDA in June. However, the extension of the NDA review does not impact the priority review status. The company informed on its third-quarter earnings call that it had received information requests from the FDA related to the Oleogel-S10 NDA review. It has also submitted all requested information to the FDA on time.
The FDA determined that the submission of additional requested data by Amryt constitutes a major amendment to the NDA. Previously, the regulatory decision was expected by the end of this month. The FDA has also made a new information request related to the existing study data to the company.
The company plans to commercialize the drug under the trade name of Filsuvez.
Shares of Amryt declined 10.4% on Nov 23 due to the potential delay in approval of Oleogel-S10. In fact, shares of Amryt have declined 28.8% so far this year compared with the
industry’s decrease of 16.4%. Image Source: Zacks Investment Research
We note that the company has also submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA), seeking approval of Oleogel-S10 for a similar skin disorder indication. The company has also faced questions from the EMA following the MAA submission. An opinion from the Committee for Medicinal Products for Human Use is expected next month.
Amryt’s commercial portfolio comprises several drugs with three drugs driving the majority of revenues —. metreleptin, lomitapide and Mycapssa. The company’s total revenues gained almost 20% year over year in the first nine months of 2021. The potential addition of Oleogel-S10 should boost the company’s top line going forward. The company estimates the global market for junctional and dystrophic EB indication to exceed $1 billion, representing a significant growth opportunity for the company.
Zacks Rank & Stocks to Consider
Amryt currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are
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Inhibrx’s loss per share estimates have narrowed from $2.31 to $2.07 for 2021 and from $2.27 to $2.21 for 2022. Inhibrx delivered an earnings surprise of 4.95%, on average, in the last four quarters. Shares of Inhibrx have gained 19.7% so far this year.