pdufa.bio
Home › Decisions › AXSM 2026-04-30

AXSM FDA decision — Apr 30, 2026

✓ APPROVED

Axsome Therapeutics Inc. — AUVELITY (dextromethorphan HBr and bupropion · Agitation in patients with Alzheimer’s disease (AD.

Run-up into the decision (T-120 → T+5)

PDUFA 4/30/26$189.1$135.6911/13/25
Daily close, T-120 (11/13/25) through T+5. Run-up high $189.1 on 1/23/26, low $135.69 on 11/13/25 (T-120 to T-1). FDA decision 4/30/26. Historical price action, not a forecast.

Key facts

FDA decision date2026-04-30
OutcomeApproved
Drug / candidateAUVELITY (dextromethorphan HBr and bupropion
CompanyAxsome Therapeutics Inc.
120-day run-up (T-120→T-1)+35.6%
Not affiliated with or endorsed by the FDA. Informational and educational only — not investment advice. Verify against primary FDA / SEC / company filings. © 2026 pdufa.bio