Axsome Therapeutics Announces FDA Acceptance and Priority Review of Supplemental New Drug Application for AXS-05 for the Treatment of Alzheimer's Disease Agitation [Yahoo! Finance]
Axsome Therapeutics, Inc. (AXSM)
Last axsome therapeutics, inc. earnings: 3/12 07:00 am
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Source: Yahoo! Finance
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 FDA's goal is to take action on an application within 6 months, compared to 10 months under standar
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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