ZGNX Hits All-time High On Positive Dravet Syndrome Drug Results

(RTTNews) - Shares of Zogenix, Inc. (ZGNX) are up over 20% in pre-market trading on Thursday, following positive top-line results from its second confirmatory phase III study of its investigational drug, ZX008 for the treatment of children and young adults with Dravet syndrome.

Dravet syndrome is a rare form of childhood epilepsy with life threatening consequences.

In the phase III trial, dubbed Study 1504, patients taking ZX008 achieved a 54.7% greater reduction in mean monthly convulsive seizures compared to placebo. The median reduction in monthly convulsive seizure frequency was 62.7% in the ZX008 group compared to 1.2% in placebo patients.

The Company had reported positive top-line results from its first pivotal phase III trial of ZX008 in Dravet Syndrome, dubbed Study 1, in September 2017.

ZX008 is designated as an orphan drug in both the U.S. and Europe, and has received Breakthrough Therapy designation in the U.S. for the treatment of Dravet syndrome.

Zogenix plans to make regulatory submissions in the U.S. and Europe seeking approval of ZX008 in Dravet Syndrome in the fourth quarter of 2018.

There is only one FDA-approved drug for Dravet Syndrome, and that is Epidiolex, developed by GW Pharmaceuticals Plc (GWPH). It was approved by the U.S. regulatory agency as recently as June 25.

Apart from Zogenix and GW Pharmaceuticals, there are a few other players too in this space - like Biocodex SA, INSYS Therapeutics Inc. (INSY) and PTC Therapeutics (PTCT).

ZGNX closed Wednesday's trading at $46.30, up 0.11%. In pre-market trading on Thursday, the stock is up over 20% at $55.70.