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)
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%
Questions
Was AUVELITY (dextromethorphan HBr and bupropion approved by the FDA?
Yes. The FDA approved the application for AUVELITY (dextromethorphan HBr and bupropion on April 30, 2026. The primary source is linked on this page.
Which company is behind AUVELITY (dextromethorphan HBr and bupropion?
AUVELITY (dextromethorphan HBr and bupropion is a Axsome Therapeutics Inc. (AXSM) program. The FDA decision came on April 30, 2026; the company's own announcement 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.
Not affiliated with or endorsed by the FDA. pdufa.bio is an independent publication with no affiliation with, endorsement by, sponsorship by, or connection to the U.S. Food and Drug Administration or any other government agency. “FDA”, “PDUFA” and all company, drug and ticker names are used descriptively and remain the property of their respective owners.
Informational and educational purposes only. Not investment advice. Nothing on this page is investment, legal, tax or medical advice, or an offer or solicitation to buy or sell any security. pdufa.bio is not a registered investment adviser or broker-dealer and does not recommend trades or publish individual-drug approval probabilities. Verify every date and outcome against primary FDA, SEC or company filings. Data is provided as is, without warranty of any kind, and past behaviour does not predict future outcomes.