Welcome to our dedicated page for Axsome Therapeut news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeut stock.
Axsome Therapeutics, Inc. reports news on its biopharmaceutical business focused on central nervous system disorders, including marketed medicines and late-stage neuroscience programs. Company updates commonly cover FDA actions, product revenue for AUVELITY, SUNOSI and SYMBRAVO, business results, investor presentations, and development activity in neurological and psychiatric conditions.
Recurring topics include AUVELITY for major depressive disorder and agitation associated with dementia due to Alzheimer’s disease, SUNOSI for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, migraine treatment commercialization, and pipeline work involving solriamfetol, AXS-12 and PDE10A inhibitor programs.
Axsome Therapeutics (NASDAQ: AXSM) announced an investor event on May 1, 2026 at 8:00 AM ET discussing the U.S. FDA approval of AUVELITY (dextromethorphan HBr and bupropion HCl) for treatment of agitation associated with dementia due to Alzheimer’s disease.
AUVELITY is described as a first-in-class treatment targeting NMDA and sigma-1 receptors. Dr. Jeffrey Cummings will provide clinical perspective; management will review the drug and anticipated commercial plans. A live webcast and 30-day replay are available on the company website.
Axsome (NASDAQ: AXSM) announced FDA approval of AUVELITY (dextromethorphan HBr and bupropion HCl) on April 30, 2026, for the treatment of agitation associated with dementia due to Alzheimer’s disease.
The approval is supported by Phase 3 ADVANCE-1 and long-term ACCORD-2 data showing statistically significant improvement on the CMAI and longer time to relapse; AUVELITY has been administered to >300,000 patients to date.
Axsome Therapeutics (NASDAQ: AXSM) will report first quarter 2026 financial results on May 4, 2026 before U.S. markets open and host a conference call at 8:00 a.m. ET.
Investors can join via domestic dial-in (877) 405-1239, international +1 (201) 389-0851, or a live webcast on the company’s Investors > Webcasts & Presentations page. A replay will be available on the website for about 30 days after the event.
Axsome Therapeutics (NASDAQ: AXSM) acquired exclusive global rights to balipodect (TAK-063), a selective PDE10A inhibitor aimed at schizophrenia and Tourette syndrome.
Balipodect completed a 164-patient Phase 2 proof-of-concept in schizophrenia and has been studied in over 360 individuals; Axsome plans Phase 3 trial-enabling activities in 2026. Takeda received an upfront payment plus potential milestone and royalty payments.
Axsome Therapeutics (NASDAQ: AXSM) will participate in multiple investor conferences in early March 2026, including TD Cowen, Leerink Partners, Citizens Life Sciences, UBS Biotech Summit Miami, and Jefferies Biotech on the Beach.
Fireside chats occur March 2, 9 and 10; investor meetings occur March 10–11. Live webcasts for TD Cowen, Leerink, and Citizens presentations will be available on the company’s Investors "Webcasts & Presentations" page; replays will be accessible for about 30 days after each event.
Axsome Therapeutics (NASDAQ: AXSM) announced dosing of the first patient in the CLARITY Phase 3 trial of solriamfetol for adults with major depressive disorder (MDD) with excessive daytime sleepiness (EDS) on Feb 24, 2026.
CLARITY is a double-blind, placebo-controlled, multicenter randomized withdrawal trial with an open-label solriamfetol period, then 1:1 randomization for patients who respond; the primary endpoint is time from randomization to relapse of depressive symptoms.
Axsome Therapeutics (NASDAQ: AXSM) reported strong commercial growth in 4Q and full year 2025 with $196.0M and $638.5M total net product revenue, up 65% and 66% year-over-year. AUVELITY, SUNOSI, and SYMBRAVO all grew; cash totaled $322.9M. Strategic updates include acquisition of AXS-17 and a PDUFA date of April 30, 2026 for AXS-05 in Alzheimer’s disease agitation.
Axsome Therapeutics (NASDAQ: AXSM) will present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on Wednesday, February 25, 2026 at 2:00 p.m. ET. The company said a live webcast will be available on its Investors "Webcasts & Presentations" page.
A replay will be available for approximately 30 days following the event. This is a standard investor conference presentation with no financial results or clinical data provided in this notice.
Axsome Therapeutics (NASDAQ: AXSM) announced a settlement with Alkem Laboratories resolving patent litigation over SUNOSI (solriamfetol). Under the agreement, Alkem may market a generic SUNOSI on or after March 1, 2040 (or September 1, 2040 if pediatric exclusivity is granted), subject to FDA approval and customary conditions.
The companies will submit the settlement to the U.S. Federal Trade Commission and Department of Justice for review. Separate SUNOSI litigation against another party remains pending in New Jersey.
Axsome Therapeutics (NASDAQ: AXSM) will report fourth quarter and full year 2025 financial results on Monday, February 23, 2026, before U.S. market open. Management will host a conference call at 8:00 a.m. Eastern Time to discuss results and provide a business update.
Live participation: dial (877) 405-1239 (U.S.) or +1 (201) 389-0851 (international). A live webcast will be available on Axsome's Investors > Webcasts & Presentations page at www.axsome.com. A replay will be accessible on the company website for approximately 30 days after the live event.