Zogenix wins inside track at FDA with childhood epilepsy ‘breakthrough’
Zogenix has won the FDA’s breakthrough therapy designation following some impressive Phase III data announced last fall, gaining an inside track at the agency for its closely watched Dravet syndrome drug ZX008.
A bit of a Wall Street darling at the moment, Zogenix $ZGNX has watched its stock soar over 175% since it released data on the first of two Phase III studies for this drug. The company reported ZX008, designed to tackle a severe form of childhood epilepsy, triggered a dramatic drop in the rate of seizures experienced by patients with Dravet syndrome. At the high end, the dose cut the monthly convulsive seizure frequency by 72.4% compared to a 17.4% drop in placebo patients.
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