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) 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.
Axsome Therapeutics (NASDAQ: AXSM) announced dosing of the first patient in the FORWARD Phase 3 trial of AXS-14 (esreboxetine) for the management of fibromyalgia on January 15, 2026. FORWARD is a multicenter, double-blind, placebo-controlled, randomized withdrawal trial that starts with a 12-week open-label AXS-14 treatment period followed by randomization 1:1 to continue AXS-14 8 mg once daily or switch to matching placebo for up to 12 weeks or until loss of therapeutic response. The primary endpoint is time from randomization to loss of therapeutic response. The design targets patients who achieve a treatment response during the open-label period and evaluates durability of effect versus placebo withdrawal.
Axsome Therapeutics (NASDAQ: AXSM) provided preliminary unaudited net product revenue for Q4 and full year 2025. Total preliminary net product revenue was $196.0 million for Q4 2025 and $638.5 million for full year 2025, representing 65% and 66% annual growth, respectively. AUVELITY preliminary net product sales were $155.1 million for Q4 and $507.1 million for full year 2025. SUNOSI preliminary net product revenue was $36.7 million for Q4 and $124.8 million for full year 2025. SYMBRAVO preliminary sales were $4.1 million for Q4 and $6.6 million for full year 2025 after its June 2025 launch. These figures are preliminary, unaudited, and subject to completion of financial close procedures.
Axsome Therapeutics (NASDAQ: AXSM) announced the FDA has accepted and granted Priority Review to its supplemental NDA for AXS-05 for treatment of Alzheimer’s disease agitation, with a PDUFA target action date of April 30, 2026.
The filing follows a comprehensive clinical program including four randomized, double-blind, controlled Phase 3 trials and a long-term safety trial. The FDA previously granted Breakthrough Therapy designation for AXS-05 in June 2020. Company commentary cites that up to 76% of people with Alzheimer’s experience agitation and that approved treatments are scarce.