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Small Cap Rare Disease Biotechs Jump After Peer Amicus Gets FDA Nod

Shares of small cap biotech companies involved in rare disease cures are trading higher after peer Amicus Therapeutics (FOLD) announced this morning that the FDA informed the company that it may now submit an NDA for Fabry disease treatment migalastat.

FDA REVERSES PRIOR DECISION: In late Noveber 2016, shares of Amicus plunged after announcing that the FDA would not consider approving migalastat, ruling out a quick approval path. Amicus said in a statement at the time, "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 symptoms in Fabry patients who have an amenable mutation." Following last year's FDA decision on migalastat, Cowen analyst Ritu Baral lowered...


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