AXSM PDUFA Date: AXS-12 Updated August 19, 2026 ยท next FDA decision on the calendar FDA decision (PDUFA) target May 1, 2027 · Axsome Therapeutics, Inc.
Key facts FDA PDUFA target date 2027-05-01
Drug / candidate AXS-12
Company Axsome Therapeutics, Inc.
Market-cap tier Large
New to FDA decisions? Read what a PDUFA date is and how often the FDA approves drugs .
See the full 2026 PDUFA calendar → FAQ When is the AXSM PDUFA date? The FDA PDUFA target date for AXSM (Axsome Therapeutics, Inc.) is 2027-05-01 for AXS-12. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is AXSM's drug AXS-12? AXS-12 is Axsome Therapeutics, Inc.'s candidate under FDA review.
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