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FDA requests additional info on Zogenix's late-stage study of ZX008; shares down 14% after hours

Oct. 19, 2015 4:26 PM ETZogenix, Inc. (ZGNX) StockBy: Douglas W. House, SA News Editor
  • Zogenix (NASDAQ:ZGNX) reports that the FDA has requested additional information pertaining to its proposed Phase 3 program for ZX008 for Dravet syndrome, specifically information related to normative ranges for echocardiograms performed during the trial and an amended study protocol to include a required follow-up echocardiogram three to six months after patients discontinue treatment with ZX008. The company has responded to the agency's request and expects to initiate the Phase 3 study this quarter.
  • Shares are down 14% after hours on light volume.

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