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Amicus plummets on NDA delay

October 2, 2015 11:57 PM UTC

Amicus Therapeutics Inc. (NASDAQ:FOLD) shed $7.36 (53%) to $6.39 on Friday, losing all of its 2015 gains, after the company said it no longer planned to submit an NDA to FDA by YE15 for Amigal migalastat to treat Fabry's disease.

Last month, Amicus said it was on track to submit an NDA in 4Q15 requesting accelerated approval. On a conference call Friday, Chairman and CEO John Crowley said FDA is requesting data analyses that will take several months to complete. ...