IONS

Zilganersen

FDA PDUFA Target Action Date · Ionis Pharmaceuticals, Inc.

Tuesday, September 22, 2026

2 days away

Note: FDA accepted NDA and granted Priority Review (announced Mar 23, 2026); PDUFA Sept 22, 2026. Antisense (RNA-targeted) medicine; pivotal study met primary endpoint (10-Meter Walk Test gait speed). Would be first disease-modifying therapy for Alexander disease.

Drug Information

Drug Name: Zilganersen (CT.gov)
Application Type: NDA
FDA Designations: Priority ReviewBreakthroughOrphan DrugRare Pediatric Disease
Indication: Alexander disease (AxD)

Filing Details

Company: Ionis Pharmaceuticals, Inc. →
Stock Ticker: IONS
SEC CIK
Source: company press release →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

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Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue