Welcome to our dedicated page for Axsome Therapeutics news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeutics 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 (AXSM) reported results from the Shared Goals: Navigating Alzheimer’s Agitation caregiver survey, presented at Psych Congress 2026 in New Orleans on September 17-18, 2026.
The online Harris Poll survey, conducted with input from CaringKind and sponsored by Axsome, included 751 U.S. adults currently providing unpaid care to a loved one with Alzheimer’s disease. Ninety-seven percent of care partners said agitation negatively affected their loved one’s quality of life, and similar shares cited impacts on self-care (96%) and community engagement (95%). While 85% were highly involved in treatment decisions, 76% wished they had recognized agitation symptoms sooner and 53% regretted not speaking to healthcare providers earlier. Caregivers highlighted nonaggressive agitation symptoms as especially detrimental and expressed strong interest in better tools to track and share symptoms, and in treatments that reduce agitation without added side effects.
Axsome Therapeutics (AXSM) is presenting ten posters covering psychiatry and neurology at Psych Congress 2026, held September 15-19 in New Orleans, Louisiana.
The presentations include new data in major depressive disorder and Alzheimer’s disease agitation, along with encore posters across Axsome’s central nervous system portfolio. Three Alzheimer’s disease agitation posters address clinical burden, real-world treatment patterns, and care partner survey results. Multiple major depressive disorder posters focus on dextromethorphan-bupropion, examining anti-anhedonic, anxiolytic, and functional effects, as well as real-world outcomes. Additional posters highlight solriamfetol for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea, and AXS-12 and survey-based outcomes in narcolepsy with cataplexy.
Axsome Therapeutics (AXSM) will participate in multiple healthcare investor conferences in September 2026, including events hosted by Wells Fargo, Cantor, Morgan Stanley, Baird, H.C. Wainwright, and Deutsche Bank.
Fireside chats and a presentation are scheduled between September 9–17, 2026, in Boston and New York. Live webcasts for the Wells Fargo, Cantor, H.C. Wainwright, and Morgan Stanley sessions, along with 30-day replays, will be available via the “Webcasts & Presentations” page in the Investors section of axsome.com.
Axsome Therapeutics (NASDAQ: AXSM) reported dosing the first patient in SUMMIT, a Phase 3 trial of AXS-05 for smoking cessation. The randomized, double-blind, active- and placebo-controlled multicenter study will compare AXS-05, bupropion, and placebo over approximately 12 weeks in adult smokers, with the primary endpoint of smoking abstinence at week 12.
Axsome Therapeutics (NASDAQ: AXSM) reported 2Q 2026 total net product revenue of $218.4 million, up 46% year over year. AUVELITY generated $180.3 million (+51% YoY), SUNOSI $35.8 million (+20% YoY), and SYMBRAVO $2.3 million (+461% YoY).
Net loss was $51.3 million, or $(0.99) per share, versus a $48.0 million loss a year ago, including $27.1 million of stock-based compensation. SG&A expenses rose to $208.1 million, primarily from AUVELITY and SYMBRAVO commercialization. Cash and cash equivalents were $319.9 million on June 30, 2026, which the company believes is sufficient to fund operations into cash flow positivity.
AUVELITY launched in June 2026 for agitation associated with dementia due to Alzheimer’s disease, with total 2Q prescriptions of approximately 266,000. Axsome’s pipeline advanced with FDA acceptance of the AXS-12 NDA (PDUFA May 1, 2027), initiation of two Phase 3 ADHD trials for solriamfetol, and ongoing Phase 3 studies across multiple indications.
Axsome Therapeutics (NASDAQ: AXSM) announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027.
According to Axsome Therapeutics, the FDA also indicated that it does not currently plan to hold an advisory committee meeting to discuss the application.
Axsome Therapeutics (NASDAQ: AXSM) announced it will report its second quarter 2026 financial results on Monday, August 10, 2026, before the U.S. market open. Management will host a conference call at 8:00 a.m. Eastern Time, with live webcast and 30-day replay available on the company’s investor website.
Axsome Therapeutics (NASDAQ: AXSM) has dosed the first patient in FOCUS-2, a Phase 3 trial of solriamfetol in children with ADHD.
The randomized, double-blind, placebo-controlled, multicenter study will enroll about 468 patients aged 6 to <12, with a 6-week treatment period and ADHD-RS-5 score change as the primary endpoint. It complements the adolescent FOCUS-3 trial.
Axsome Therapeutics (NASDAQ:AXSM) has dosed the first patient in its FOCUS-3 Phase 3 trial of solriamfetol for adolescents with ADHD. The randomized, double-blind, placebo-controlled, multicenter study will enroll about 468 patients aged 12 to under 18 years, treated for 6 weeks. The primary endpoint is change from baseline to week 6 in ADHD-RS-5 total score.
Axsome Therapeutics (NASDAQ: AXSM) is supporting Alzheimer’s & Brain Awareness Month by partnering with advocacy and caregiver organizations to promote brain health and Alzheimer’s resources. Axsome staff will join more than 30 Walk to End Alzheimer’s events, support New York City educational programs, and light its One World Trade Center headquarters purple on June 21.