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IONS PDUFA Date: Zilganersen (ION373)

FDA decision (PDUFA) target 2026-09-22 · Ionis Pharmaceuticals Inc. · Alexander disease

IONS run-up into the PDUFA (last ~120 days)

$85.45$69.68
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA PDUFA target date2026-09-22
Drug / candidateZilganersen (ION373)
IndicationAlexander disease
CompanyIonis Pharmaceuticals Inc.
Market-cap tierLarge
Cohort decision-day move (history)±1% median
ClinicalTrials.govNCT04849741 · Fast Track Designation (FTD)

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FAQ

When is the IONS PDUFA date?
The FDA PDUFA target date for IONS (Ionis Pharmaceuticals Inc.) is 2026-09-22 for Zilganersen (ION373). Dates are company/FDA-sourced and can slip — verify against primary filings.
What is IONS's drug Zilganersen (ION373)?
Zilganersen (ION373) is Ionis Pharmaceuticals Inc.'s candidate under FDA review for Alexander disease.
What typically happens to a large-cap stock into a PDUFA date?
Historically, large-cap names had a median decision-day move around ±1% (694-PDUFA cohort, 2024–26). This is historical context by market-cap tier, not a prediction for this drug.