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pdufa.bio

AXS-14

Updated ยทnext FDA decision on the calendar

AXS-14 is a Axsome Therapeutics, Inc. program. 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). We track 1 catalyst event for this program: 0 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 · Jul 2026AXSM

Questions

When is AXS-14's next FDA decision or readout?

No upcoming catalyst is on our calendar for AXS-14; no FDA decisions are on record below.

What happened at AXS-14's most recent FDA decision?

No FDA decision for AXS-14 is in our archive yet.

Who makes AXS-14?

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.