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FDA accepts Amicus' migalastat NDA for Fabry; action date August 13; shares up 4% premarket

Feb. 12, 2018 7:47 AM ETAmicus Therapeutics, Inc. (FOLD) StockBy: Douglas W. House, SA News Editor3 Comments
  • The FDA accepts for review Amicus Therapeutics' (NASDAQ:FOLD) marketing application seeking approval for migalastat HCL for the treatment of patients at least 16 years old with Fabry disease who have certain genetic mutations. The agency's action date is August 13.
  • Fabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene.
  • Orphan Drug- and Fast Track-tagged migalastat, branded as Galafold, is a chaperone therapy that works by stabilizing the body's dysfunctional alpha-Gal A so it can clear the accumulation of disease substrate in patients with certain genetic mutations.
  • Shares are up 4% premarket on light volume.
  • Fabry-related tickers: (PLX)(OTCPK:RVXCF)(SNY)
  • Previously: Amicus submits U.S. marketing application for Fabry med migalastat; shares up 2% premarket (Dec. 14, 2017)

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