Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer’s Disease Agitation
Axsome Therapeutics, Inc. (AXSM)
Last axsome therapeutics, inc. earnings: 3/12 07:00 am
Check Earnings Report
US:NASDAQ Investor Relations:
axsome.com
Company Research
Source: GlobeNewswire
FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s supplemental New Drug Application (NDA) for AXS-05 (dextromethorphan HBr and bupropion HCl) for the treatment of Alzheimer’s disease agitation, and has granted the application Priority Review designation. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026. Priority Review is granted by the FDA to applications for medicines that, if approved, would provide significant improvements in the effectiveness or safety of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. A Priority Review designation means the FD
Show less
Read more
Impact Snapshot
Event Time:
AXSM
Last Price
Price Change
Price Change%
Volume Shares
Max Up
Max Down
%
Volume Ratio
Performance Comparison
Updated
|
Event Day
Stock performance from the time of news release until the following 4pm ET market close
|
Last price at news event
|
Since Event
Multi-day stock performance from the time of the news release
|
|---|---|---|
|
EVENT DAY
Stock performance from the time of news release until the following 4pm ET market close
|
LAST
PRICE AT NEWS EVENT |
SINCE EVENT
Multi-day stock performance from the time of the news release
|
| Last Price | ||
| VWAP | ||
|
High:
|
Max Up |
High:
|
|
Low:
|
Max Down |
Low:
|
|
%
|
Post news range |
%
|
|
|
Price change |
|
|
|
Price Change Percentage |
|
|
|
S&P 500 (SPX) |
|
|
%
|
Volume ratio |
%
|
| Volume | ||
| Ticks | ||
|
|
Avg transaction size |
|
Don't Miss Out On The Next BIG Stock Move
Event day
Event Day Chart will not be displayed beyond 90-day period of the event
Performance since event
Time And Velocity Analysis
Be the first to know
Opt in for alerts from News Quantifed
Sign Up Today
Opt-in for
AXSM alerts
Learn More With NQ
Reading the Impact Report
Help Me Understand This Data
Help Me Understand This Data
How NQ Works
What is news-based trading?
And why is it so successful?
And why is it so successful?
Movers & Shakers
The biggest gainers and losers and WHY it moved
AXSM alerts
High impacting Axsome Therapeutics, Inc. news events
Weekly update
A roundup of the hottest topics
AXSM
News
- Axsome Therapeutics Initiates FORWARD Phase 3 Trial of AXS-14 for the Management of FibromyalgiaGlobeNewswire
- Axsome Therapeutics (NASDAQ:AXSM) had its "overweight" rating reaffirmed by analysts at Cantor Fitzgerald.MarketBeat
- Axsome Therapeutics (NASDAQ:AXSM) was given a new $209.00 price target on by analysts at Robert W. Baird.MarketBeat
- Axsome Therapeutics (NASDAQ:AXSM) had its "overweight" rating reaffirmed by analysts at Wells Fargo & Company.MarketBeat
- MoneyShow's Best Investment Ideas For 2026: Part 2 [Seeking Alpha]Seeking Alpha
AXSM
Earnings
- 11/3/25 - Miss
AXSM
Sec Filings
- 1/12/26 - Form 8-K
- 1/7/26 - Form 4
- 1/7/26 - Form 144
- AXSM's page on the SEC website