FDA snubs Zo­genix's an­ti-seizure drug, not hap­py with some slop­py, in­ad­e­quate R&D work

Nine months af­ter Zo­genix got a stock ral­ly $ZGNX go­ing by tout­ing late-stage da­ta for a new drug to pre­vent seizures due to Dravet syn­drome, the FDA hand­ed back their mar­ket­ing ap­pli­ca­tion with a fail­ing grade on in­ad­e­quate and in­com­plete work. Of­fi­cial­ly, that’s called a refuse-to-file no­tice, which is al­ways em­bar­rass­ing. 

It’s not the end of the world, says Zo­genix in a man­ner of speak­ing, but the agency was not hap­py that the biotech had sub­mit­ted an in­cor­rect ver­sion of a dataset with the NDA and fault­ed the com­pa­ny as “cer­tain non-clin­i­cal stud­ies were not sub­mit­ted to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine.”

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