Amryt Pharma plc
|Company Name||Amryt Pharma plc|
On February 28, 2022, Amryt disclosed receipt of a Complete Response Letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) stating that the Company’s New Drug Application for its Dystrophic and Junctional Epidermolysis Bullosa (“EB”) treatment, Oleogel-S10, could not be approved in its current form. The FDA “asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB.”
On this news, Amryt’s American Depositary Share (“ADS”) price fell $1.15, or 14.2%, to close at $6.98 per ADS on February 28, 2022, thereby injuring investors.
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