IONS

Zilganersen

FDA PDUFA Target Action Date · Ionis Pharmaceuticals, Inc.

Tuesday, September 22, 2026

Approved

approved

Note: Approved 2026-09-03 as ZANVASTRO (ORIG NDA220210). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 19d from the PDUFA date.

Drug Information

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

Filing Details

Company: Ionis Pharmaceuticals, Inc. →
Stock Ticker: IONS
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

Explore Ionis Pharmaceuticals, Inc.

View Ionis Pharmaceuticals, Inc.'s full pipeline, approved drugs, and clinical trials.

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