Amryt's Skin Disorder Drug Application Review With FDA Extended By Three Months

The FDA made a three-month extension to the review period for Amryt Pharma Plc's AMYT Oleogel-S10 marketing application for junctional and dystrophic epidermolysis bullosa (EB).

• EB is a rare genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
• The FDA extended the date to the end of February 2022.
• The extension allows time to review additional analyses of data previously submitted by Amryt.
• The FDA also made a new information request regarding existing study data to continue its application evaluation, which the regulator confirmed in June this year had been accepted and granted priority review.
• The extension has no impact on the priority review status of Oleogel-S10, Amryt said.
• European regulators are expected to receive an opinion from the Committee for Medicinal Products for Human Use (CHMP) in January 2022.
• The Company said its previously issued revenue guidance for FY 2021 of $220 million - $225 million is unaffected by the new regulatory timelines.
• Analyst Reaction: SVB Leerink maintains Outperform rating on Amryt but has lowered the price target to $19.
• Yesterday, Amryt Pharma announced plans to delist from the Alternative Investment Market (AIM) in London.
• It said its last day of trading on AIM would be January 10, 2022, noting it would retain its listing on the NASDAQ.
• Price Action: AMYT shares are down 10.80% at $10.03 during the market session on the last check Tuesday.