Amicus Therapeutics tanks on news of delay for migalastat approval

3 October 2015

US biotech firm Amicus Therapeutics (Nasdaq: Fold) saw its market capitalization more than halve on Friday, as its share dropped 53.5% to $6.39 when it revealed that the US Food and Drug Administration is calling for additional data before approving its Fabry disease drug candidate migalastat.

Amicus said it has received final FDA minutes from the September pre-New Drug Application meeting and has conducted additional follow-up interactions with the agency this week. In conjunction with the FDA, Amicus is further evaluating several US pathways including potentially generating additional data on migalastat's effect on gastrointestinal symptoms in Fabry disease to support submission requesting full approval as well as a Subpart H strategy.

Regulatory filing now not likely by end-2015

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