Zogenix Soars On Positive Phase 3 Data In Dravet Syndrome Study

Zogenix, Inc. ZGNX peaked nearly 30 percent in Thursday's pre-market session after management released positive top-line results from its second pivotal Phase 3 study of ZX008 in Dravet Syndrome.

The trial met primary and secondary endpoints and demonstrated statistical significance in reducing convulsive seizures.

Why It’s Important

The investigational drug is meant to treat a rare form of epilepsy, which begins in the first year of a person's life, with few available treatment options. It has received orphan drug designation in both the U.S. and Europe with additional breakthrough designation in the U.S.

"These impressive study results show the significant impact the addition of ZX008 made in reducing the burden of convulsive seizures for patients who are not adequately controlled using stiripentol, the standard of care for the treatment of Dravet syndrome in Europe," Rima Nabbout, principal investigator of the study, said in a press release.

GW Pharmaceuticals PLC-ADR GWPH, which received approval for its competing anti-seizure medication in June, fell 4 percent on Zogenix’s success.

What’s Next

Zogenix will submit U.S. and European regulatory filings in the fourth quarter. The Food and Drug Administration has already affirmed two prior studies were suitable clinical bases for a planned New Drug Application.

The stock traded around $59.95 at time of publication, up 29 percent.

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