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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.

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