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pdufa.bio

Sonelokimab

Updated ยทnext FDA decision on the calendar

Sonelokimab is a MoonLake Immunotherapeutics program. Its next catalyst is a Readout in Feb 2027. Every date links its source.

MLTX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: MoonLake Immunotherapeutics (MLTX). 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

Readout · Sep 2026MLTXReadout · Feb 2027MLTX

Questions

When is Sonelokimab's next FDA decision or readout?

The next tracked catalyst for Sonelokimab is a Readout in Feb 2027.

What happened at Sonelokimab's most recent FDA decision?

No FDA decision for Sonelokimab is in our archive yet.

Who makes Sonelokimab?

MoonLake Immunotherapeutics (MLTX).

Where does this data come from?

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