Amryt Pharma plc Investigation
The law firm of Kirby McInerney LLP is investigating potential claims against Amryt Pharma plc (“Amryt Pharma” or the “Company”) (NASDAQ: AMYT). The investigation concerns whether Amryt Pharma has violated the federal securities laws and/or engaged in other unlawful business practices.
Amryt Pharma operates as a biopharmaceutical company. The Company develops and delivers treatments for rare and orphan diseases.
On February 28, 2022, Amryt Pharma issued a press release “announc[ing] it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Oleogel-S10, for the treatment of the cutaneous manifestations of Dystrophic and Junctional Epidermolysis Bullosa (EB)”. Amryt Pharma reported that “[t]he FDA communicated that it had completed its review of the application and has determined that the application cannot be approved in its present form” and “has asked Amryt to submit additional confirmatory evidence of effectiveness for Oleogel-S10 in EB.” On this news, Amryt Pharma’s American Depositary Shares (“ADSs”) declined by $1.15 per ADS, or approximately 14.15%, from $8.13 per ADS to close at $6.98 per ADS on February 28, 2022.