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pdufa.bio

Donidalorsen

Updated ยทnext FDA decision on the calendar

Donidalorsen is a Ionis Pharmaceuticals Inc. program. Its next catalyst is a Readout in Dec 2026. 2 FDA decisions on record below. Every date links its source.

IONI catalyst hub · IONS catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Donidalorsen is marketed as Dawnzera (donidalorsen); the events below include those tracked under the brand name. Sponsor: Ionis Pharmaceuticals Inc. (IONI, IONS). We track 3 catalyst events for this program: 1 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 · Aug 21, 2025 ✓ ApprovedIONIPDUFA · Aug 21, 2025 ✓ ApprovedIONSReadout · Dec 2026IONS

Questions

When is Donidalorsen's next FDA decision or readout?

The next tracked catalyst for Donidalorsen is a Readout in Dec 2026.

What happened at Donidalorsen's most recent FDA decision?

On Aug 21, 2025 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes Donidalorsen?

Ionis Pharmaceuticals Inc. (IONI, IONS).

Has Donidalorsen been approved by the FDA?

Yes. The FDA approved an application for Donidalorsen on Aug 21, 2025; 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.