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Investors are going to have to wait awhile before they see Amicus Therapeutics submit its Fabry Disease drug to the FDA for approval. And they immediately showed their displeasure by sending the Cranbury, NJ-based company’s stock down more than 20 percent. John Crowley, Amicus’ CEO, said on a conference call Monday that following discussions with the FDA, Amicus (NASDAQ: FOLD) has decided the data from its late-stage clinical trial of migalastat HCl isn’t enough to get the drug approved. Instead, Amicus will complete that study, as well as another ongoing Phase 3 trial before filing a new drug application (NDA) with the FDA. While that doesn’t mean migalastat is done as a potential treatment for Fabry, it does mean the verdict won’t be known for some time.
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