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pdufa.bio

Zilganersen

Updated ยทnext FDA decision on the calendar

Zilganersen is a Ionis Pharmaceuticals Inc. program in Alexander disease. The FDA approved it on Sep 3, 2026. 1 FDA decision on record below. Every date links its source.

IONS catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Zilganersen is marketed as Zanvastro (zilganersen); the events below include those tracked under the brand name. Indication under review: Alexander disease. Sponsor: Ionis Pharmaceuticals Inc. (IONS). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Sep 3, 2026 ✓ ApprovedIONSPDUFA · Sep 22, 2026IONS

Questions

When is Zilganersen's next FDA decision or readout?

No upcoming catalyst is on our calendar for Zilganersen; 1 FDA decision is on record below.

What happened at Zilganersen's most recent FDA decision?

On Sep 3, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

What is Zilganersen used for?

In our records Zilganersen is under review or in development for Alexander disease.

Who makes Zilganersen?

Ionis Pharmaceuticals Inc. (IONS).

Has Zilganersen been approved by the FDA?

Yes. The FDA approved an application for Zilganersen on Sep 3, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.