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Auvelity (supplemental) (dextromethorphan HBr / bupropion HCl (AXS-05))

Axsome Therapeutics · $AXSM
Priority Review Breakthrough Therapy sNDA
PDUFA Date
April 30, 2026
Time Remaining
4 days
Review Type
Priority (6 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
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Live Company Data NGM

Updated just now · Data: FMP
Current Price
$185.96 +76.42%
+$80.55 today
Day: $180.90 – $191.14
Market Cap
N/A
Shares out: 51.15M
Float: 43.24M
52-Week Range
$96.09
$191.50
Current price is at 94% of 52-week range
Avg Volume
589K
Beta
0.47
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

Alzheimer's disease agitation

Key Notes

Supplemental NDA accepted with Priority Review. PDUFA April 30, 2026. AXS-05 (dextromethorphan HBr/bupropion HCl) is already FDA-approved as Auvelity for major depressive disorder. This sNDA expands the label to Alzheimer's disease agitation — supported by four randomized, double-blind, controlled Phase 3 clinical trials and a long-term safety study. First NMDA receptor antagonist/sigma-1 receptor agonist mechanism in AD agitation.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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