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 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.
Axsome Therapeutics (NASDAQ: AXSM) is presenting new data on its sleep medicine portfolio at SLEEP 2026 in Baltimore. Posters cover AXS-12 in narcolepsy with cataplexy, solriamfetol for excessive daytime sleepiness in narcolepsy and OSA, and symptom burden and quality of life in narcolepsy.
Axsome Therapeutics (NASDAQ: AXSM) is presenting new SYMBRAVO migraine data at the American Headache Society 68th Annual Scientific Meeting in Orlando, June 4–7, 2026. Four posters cover post-hoc efficacy and safety analyses, comparative efficacy versus gepants, and sustained pain relief outcomes from Phase 3 MOMENTUM, MOVEMENT, and INTERCEPT trials.
Axsome Therapeutics (NASDAQ:AXSM) announced a settlement resolving all patent litigation related to SUNOSI (solriamfetol) in the United States. The cases stemmed from generic companies’ ANDA filings.
According to Axsome, five companies may sell generic SUNOSI starting on or after Sept 1, 2040 with pediatric exclusivity, or Mar 1, 2040 without, subject to FDA approval and customary conditions. No other SUNOSI patent litigation is pending, and the settlement will be submitted to the FTC and DOJ for review.
Axsome Therapeutics (NASDAQ: AXSM) is supporting educational initiatives during Migraine and Headache Awareness Month in June 2026. The company is backing the first annual Headache in the City campaign on June 15 in New York City and lighting its One World Trade Center headquarters purple on June 4 to promote migraine awareness.
Axsome is also amplifying patient resources from leading migraine advocacy organizations, including tools to find specialists, explainer videos, financial assistance guides, and educational podcasts.
Axsome Therapeutics (NASDAQ: AXSM) announced participation in several June 2026 investor conferences, featuring fireside chats at events hosted by William Blair, Jefferies, Goldman Sachs, Oppenheimer, and UBS.
Live webcasts for select sessions and 30-day replays will be available via the company’s investor relations website.