AXSM

Axsome Therapeutics, Inc.

FDA PDUFA Target Action Date

Thursday, April 30, 2026

26 days ago

pending

Drug Information

Drug Name: AXS-05 (dextromethorphan-bupropion) (CT.gov)
Application Type: sNDA
FDA Designations: BreakthroughPriority Review
Indication: Agitation associated with Alzheimer's disease

Filing Details

Company: Axsome Therapeutics, Inc. →
Stock Ticker: AXSM
SEC CIK: 0001579428
Source: GlobeNewswire →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore Axsome Therapeutics, Inc.

View Axsome Therapeutics, Inc.'s full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-04-10. Report an issue