Wk chg

10/25 cls

Amicus Therapeutics Inc. (NASDAQ:FOLD)


Joseph Schwartz


Market perform (from market outperform)



Schwartz maintained his $3 target but said he sees "relatively limited news flow over the near term to demonstrate the company's potential transition from a chaperone monotherapy to a combo therapy story." He said Amicus' strategy of focusing on a co-formulation of its Amigal migalastat with an enzyme replacement therapy to treat Fabry's disease is "compelling" but "may take some time." He expects Amicus and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to begin clinical testing with the co-formulation in 1H14. Schwartz also noted it is unclear what FDA will require for approval of Amigal as monotherapy to treat Fabry's. In June, Amicus announced that FDA said 12-month data from the Phase III FACETS (Study 011) trial of Amigal would not support approval of an NDA. Amigal is a small molecule that enhances alpha galactosidase A activity.