Page updated ·next FDA decision on the calendar·Data as of Oct 11, 2026 9:31 PM ET
✓ APPROVED
AUVELITY was approved by the FDA on April 30, 2026.
Axsome Therapeutics Inc., AUVELITY.
Run-up into the decision (T-120 → T+5)
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.
Drug / candidateAUVELITY (dextromethorphan HBr and bupropion
CompanyAxsome Therapeutics Inc.
120-day run-up (T-120→T-1)+35.6%
FDA record of the action: the FDA approved on April 30, 2026, per NDA 215430 SUPPL-18 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Specialist biotech funds holding AXSM, 13F for the quarter ended June 30, 2026
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Questions
Was AUVELITY approved by the FDA?
Yes. The FDA approved the application for AUVELITY on April 30, 2026, per the FDA's own record. The primary source is linked on this page.
Which company is behind AUVELITY?
AUVELITY is an Axsome Therapeutics Inc. (AXSM) program. The FDA decision came on April 30, 2026; the FDA's own record of the decision is linked on this page.
How did AXSM stock trade into the FDA decision?
Measured over the 120 trading days before the decision (T-120 to T-1), AXSM moved +35.6%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
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