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. (NASDAQ: AXSM) is a biopharmaceutical company focused on central nervous system (CNS) conditions, and its news flow reflects both commercial performance and clinical development across this neuroscience portfolio. On this page, readers can follow AXSM news related to its FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as updates on its late-stage and other development programs.
Company announcements frequently cover net product revenue for AUVELITY, SUNOSI, and SYMBRAVO, as reported in quarterly financial results and preliminary revenue updates. These releases, often furnished to the SEC via Form 8-K, provide insight into prescription trends, payer coverage metrics, and the contribution of each product to Axsome’s overall revenue base.
Axsome’s news also highlights key clinical and regulatory milestones. Examples include initiation of the FORWARD Phase 3 trial of AXS-14 in fibromyalgia, FDA acceptance and Priority Review of a supplemental New Drug Application for AXS-05 in Alzheimer’s disease agitation, and pre-NDA meeting outcomes supporting an NDA submission for AXS-12 in narcolepsy. Additional items describe progress of solriamfetol in multiple Phase 3 programs and the acquisition of AZD7325 for potential use in epilepsy.
Investors and followers of AXSM stock can use this news feed to monitor earnings releases, pipeline data presentations at scientific meetings, regulatory designations, business development transactions, and Axsome’s participation in healthcare and biopharma investor conferences. Bookmarking this page allows for efficient tracking of how Axsome advances its CNS portfolio and communicates with the market over time.
Axsome Therapeutics (NASDAQ: AXSM) recognized Mental Health Month on May 7, 2026, aligning with the "More Good Days Together" theme and sharing mental‑health resources for patients, families, and communities. Axsome highlighted nonprofit tools, therapy‑finder platforms, crisis resources including the 988 Lifeline, and awareness activities.
Axsome Therapeutics (NASDAQ: AXSM) will participate in two investor conferences in May 2026: a BofA Securities Health Care Conference fireside chat on May 12, 2026 at 8:40 a.m. PT in Las Vegas, and an RBC Capital Markets Global Healthcare Conference fireside chat on May 19, 2026 at 1:35 p.m. ET in New York.
Live webcasts will be available on the company’s Investors > Webcasts & Presentations page at axsome.com, with replays posted for approximately 30 days after each event.
Axsome Therapeutics (NASDAQ: AXSM) reported Q1 2026 net product revenue of $191.2M, up 57% year-over-year, driven by AUVELITY $153.2M (+59% YoY), SUNOSI $33.9M (+34% YoY) and SYMBRAVO $4.1M. AUVELITY received FDA approval for agitation associated with dementia due to Alzheimer’s disease and full commercial launch is on track for June 2026. Q1 net loss was $64.5M (−$1.26/share). Cash and cash equivalents totaled $305.1M at March 31, 2026.
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.