AXSM FDA decision dates

Updated August 11, 2026·next FDA decision on the calendar

AXSM has 1 upcoming FDA decision date; the nearest is May 1, 2027 for AXS-12. 3 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

AXSM catalyst hub · full calendar

Upcoming

May 1, 2027 in 263 daysAXS-12

Decided

Apr 30, 2026 ✓ ApprovedAUVELITY (dextromethorphan HBr Jun 9, 2025 CRLprice-only Jan 30, 2025 ✓ Approvedprice-only

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

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