Amicus speeds Amigal submission timeline
Amicus Therapeutics Inc. (NASDAQ:FOLD) rose $3.11 (33%) to $12.46 on Thursday after the company said it will submit regulatory applications in the U.S. and Europe this year for Amigal migalastat to treat Fabry's disease. The company expects to submit an MAA to EMA in 2Q15, ahead of its previous mid-2015 goal.
Amicus plans to submit an NDA to FDA In 2H15 seeking accelerated approval of the small molecule that enhances alpha galactosidase A activity. Amicus said the agency "is open to considering" surrogate endpoints from the Phase III FACETS (Study 011) and ATTRACT (Study 012) trials. The endpoints include reduction of kidney interstitial capillary GL-3; reduction in cardiac mass, specifically left ventricular mass index (LVMi); and kidney function as assessed by glomerular filtration rate. ...