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pdufa.bio

galinpepimut-S

Updated ยทnext FDA decision on the calendar

galinpepimut-S is a SELLAS Life Sciences Group, Inc. program in Acute myeloid leukemia, maintenance in second complete remission (CR2). Its next catalyst is a Readout in Q4 2026. Every date links its source.

SLS catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Acute myeloid leukemia, maintenance in second complete remission (CR2). Sponsor: SELLAS Life Sciences Group, Inc. (SLS). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 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 · Q4 2026SLS

Questions

When is galinpepimut-S's next FDA decision or readout?

The next tracked catalyst for galinpepimut-S is a Readout in Q4 2026.

What happened at galinpepimut-S's most recent FDA decision?

No FDA decision for galinpepimut-S is in our archive yet.

What is galinpepimut-S used for?

In our records galinpepimut-S is under review or in development for Acute myeloid leukemia, maintenance in second complete remission (CR2).

Who makes galinpepimut-S?

SELLAS Life Sciences Group, Inc. (SLS).

Where does this data come from?

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