- 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.