Biotech Values

[DewDiligence]

ZGNX -18%/AH on FDA request for additional info before clearing IND (and thereby enabling the start of phase-3 trial) for ZX008:

http://finance.yahoo.com/news/zogenix-provides-regulatory-zx008-200100616.html

Zogenix…today announced the recent receipt of a request from the U.S. Food and Drug Administration (FDA) for additional information related to the Company's proposed Phase 3 program for ZX008 prior to the FDA declaring Zogenix's Investigational New Drug Application (IND) effective.

Zogenix has responded with the requested information required to initiate the clinical program. ZX008 previously received orphan drug designation from the FDA, and is expected to enter Phase 3 clinical studies during the fourth quarter of 2015 for the treatment of Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy.

The FDA's specific information requests are related to normative ranges for echocardiograms being conducted during the course of the pediatric Phase 3 program, and an amended Phase 3 study protocol to reflect a required follow-up echocardiogram 3 to 6 months after patients discontinue treatment with ZX008.