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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