Why Are Amicus Therapeutics Shares Trading Higher Today?

The FDA has accepted for review Amicus Therapeutics Inc's 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.