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Dawnzera (donidalorsen)

Updated ยทnext FDA decision on the calendar

Dawnzera (donidalorsen) 2 FDA decisions on record below. Every date links its source.

IONI catalyst hub · IONS catalyst hub

About this program

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 · Aug 21, 2025 ✓ ApprovedIONIPDUFA · Aug 21, 2025 ✓ ApprovedIONS

Questions

When is Dawnzera (donidalorsen)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for Dawnzera (donidalorsen); 2 FDA decisions are on record below.

What happened at Dawnzera (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.

Has Dawnzera (donidalorsen) been approved by the FDA?

Yes. The FDA approved an application for Dawnzera (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.