Why Are Amicus Therapeutics Shares Trading Higher Today?

The FDA has accepted for review Amicus Therapeutics Inc's (NASDAQ:FOLD) Biologics License Application (BLA) for cipaglucosidase alfa and the New Drug Application (NDA) for miglustat for AT-GAA.
Also Read: Amicus's Fabry Disease Medicine Gets European Approval For Use In Adolescents
AT-GAA two-component therapy for Pompe disease inherited lysosomal disorder characterized by severe muscle weakness.
AT-GAA consists of cipaglucosidase alfa (ATB200), a recombinant human acid alpha-glucosidase (rhGAA) enzyme administered in conjunction with miglustat (AT2221), a stabilizer of cipaglucosidase alfa.
The agency's PDUFA target action date for NDA is May 29, 2022, and July 29, 2022, for BLA.
The Marketing Authorization Application for AT-GAA in Europe is expected to be submitted in Q4 of 2021.
In June 2021, the U.K.'s Medicines and Healthcare Products Regulatory Agency granted AT-GAA a positive scientific opinion through the Early Access to Medicines Scheme.
Related content: Benzinga's Full FDA Calendar.
Price Action: FOLD stock traded 19.40% higher at $12.16 premarket on the last check Wednesday.