IONS PDUFA decision: Tuesday, September 22, 2026

EventPDUFA decision
DateTuesday, September 22, 2026
MarketUS listing
SourceSEC 8-K filing · confidence 85% · primary source ↗

…adults with Alexander disease (AxD), assuming approval   o New Drug Application (NDA) under FDA Priority Review with PDUFA target action date of September 22, 2026   o Entered a license agreement with Recordati to develop and commercialize zilganersen outside the U.S.   • Obuda

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