Amicus plummets as FDA delays drug approval

29 November 2016

Shares of US biotech firm Amicus Therapeutics (Nasdaq: FOLD) were down 24.28% at $6.30 in pre-market trading this morning, after the company late yesterday revealed that the US Food and Drug Administration has declined to allow accelerated approval for its lead Fabry disease drug.

As a result, the company announced its planned regulatory pathway to collect additional data to support full approval for the oral precision medicine migalastat for Fabry disease.

Following several collaborative discussions with the FDA, including the receipt of final written minutes from an in-person Type B meeting, the company plans to collect additional data on gastrointestinal (GI) symptoms in Fabry patients who have an amenable mutation.

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