Amicus hit hard on FDA advice for more migalastat work before NDA
This article was originally published in Scrip
Executive Summary
Shares of Amicus Therapeutics tumbled as low as 28% on 17 June after the firm's CEO disclosed the company would not seek approval of its Fabry disease drug migalastat until the second half of next year, at the earliest – revealing the FDA advised the firm to first complete its other Phase III study.