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pdufa.bio

anifrolumab

Updated ยทnext FDA decision on the calendar

anifrolumab is a Alumis Inc. program. Its next catalyst is a Readout in Q3 2026. 1 FDA decision on record below. Every date links its source.

ALMS catalyst hub · AZN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

anifrolumab is marketed as SAPHNELO (anifrolumab-fnia); the events below include those tracked under the brand name. Sponsor: Alumis Inc. (ALMS, AZN). We track 2 catalyst events for this program: 1 upcoming and 1 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 · Apr 27, 2026 ✓ ApprovedAZNReadout · Q3 2026ALMS

Questions

When is anifrolumab's next FDA decision or readout?

The next tracked catalyst for anifrolumab is a Readout in Q3 2026.

What happened at anifrolumab's most recent FDA decision?

On Apr 27, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Who makes anifrolumab?

Alumis Inc. (ALMS, AZN).

Has anifrolumab been approved by the FDA?

Yes. The FDA approved an application for anifrolumab on Apr 27, 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.