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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