Amryt Pharma Plc (NASDAQ:AMYT) saw its shares dissolve Monday near the close, on word the company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration regarding Oleogel-S10 application for cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB).
EB is a rare, genetic skin disease characterized by extremely fragile skin that blisters and tears from minor friction or trauma.
The FDA has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB.
Amryt intends to discuss the nature of the data required to address the concerns with the FDA.
To quote CEO Joe Wiley: “We are extremely disappointed by this decision, and we remain committed to our goal of bringing Oleogel-S10 to patients…The EASE study was the largest randomized clinical trial ever conducted in this disease and the first Phase 3 study to meet its primary endpoint.”
AMYT shares are down $1.31, or 16.1% at $6.82 near the end of trading Monday.