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pdufa.bio

AXS-12

Updated ยทnext FDA decision on the calendar

AXS-12 is a Axsome Therapeutics, Inc. program. Its PDUFA date is May 1, 2027, the FDA's goal date to complete review of the application. Every date links its source.

AXSM catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Axsome Therapeutics, Inc. (AXSM). Market-cap tier at the time we tracked it: Large. 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

PDUFA · May 1, 2027AXSM

Questions

When is AXS-12's next FDA decision or readout?

AXS-12's PDUFA date is May 1, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at AXS-12's most recent FDA decision?

No FDA decision for AXS-12 is in our archive yet.

Who makes AXS-12?

Axsome Therapeutics, Inc. (AXSM).

Where does this data come from?

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