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) 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.
Axsome Therapeutics (NASDAQ: AXSM) received formal FDA pre-NDA meeting minutes supporting an NDA submission for AXS-12 (reboxetine) to treat cataplexy in narcolepsy. The FDA agreed the company’s regulatory data package would be sufficient for an NDA filing. Axsome anticipates completing the NDA submission in January 2026, with acceptance subject to the FDA’s review of the complete filing.
AXS-12 clinical work includes three controlled efficacy trials and a completed long-term safety trial. AXS-12 holds Orphan Drug Designation, which may provide seven years of U.S. market exclusivity and potential user-fee waiver if approved.
Axsome Therapeutics (NASDAQ: AXSM) will participate in two investor conferences in December 2025. The company will present a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on Wednesday, December 3, 2025 at 4:00 p.m. ET in New York.
Axsome will also present a fireside chat at the BofA Securities CNS Therapeutics Virtual Conference on Monday, December 8, 2025 at 11:40 a.m. ET. A live webcast of the Piper Sandler presentation will be available on the company’s Investors & Webcasts & Presentations page, with a replay accessible for about 30 days.
Axsome Therapeutics (NASDAQ: AXSM) acquired exclusive global rights to AZD7325, an oral GABAA α2,3 subtype-selective positive allosteric modulator, from AstraZeneca via purchase of 100% of Baergic Bio on Nov 6, 2025.
AZD7325 completed Phase 1 studies in over 700 patients with a favorable safety profile and showed anti‑convulsant effects in preclinical seizure models. Axsome plans Phase 2 trial‑enabling activities in 2026. Deal terms include a $0.3M upfront to Baergic shareholders, potential development/regulatory milestones of $2.5M (first indication) plus $1.5M per additional indication, up to $79M in sales‑based milestones, and tiered mid‑to‑high single‑digit royalties; AstraZeneca will receive a single‑digit million upfront, milestones, sales milestones, and royalties.
Axsome Therapeutics (NASDAQ: AXSM) reported 3Q2025 total net product revenue of $171.0M, up 63% YoY and 14% sequentially. AUVELITY sales were $136.1M (+69% YoY); SUNOSI revenue was $32.8M (+35% YoY); SYMBRAVO generated $2.1M in its first full quarter. The company posted a net loss of $47.2M (includes $23.1M stock compensation and $13.2M contingent consideration) and held $325.3M cash at Sept 30, 2025. Axsome submitted an sNDA for AXS-05 in Alzheimer’s disease agitation and outlined multiple near-term Phase 3 initiations and anticipated 2026 topline readouts.
Axsome Therapeutics (NASDAQ: AXSM) announced participation in three investor conferences in November 2025: a Truist Securities BioPharma Symposium fireside chat on Nov 6, 2025 at 9:50 a.m. ET in New York; a Guggenheim Healthcare Innovation fireside chat on Nov 10, 2025 at 11:00 a.m. ET in Boston; and a UBS Global Healthcare fireside chat on Nov 11, 2025 at 2:00 p.m. ET in Palm Beach Gardens, FL.
Live webcasts of the Guggenheim and UBS presentations will be available on the company’s Investor "Webcasts & Presentations" page at www.axsome.com, with replays posted for approximately 30 days after each event.
Axsome Therapeutics (NASDAQ: AXSM) recognized Mental Illness Awareness Week on October 9, 2025, aligning with national advocacy groups to promote this year’s theme: “Building Community: Supporting Mental Well-being Together.”
The company highlighted free support programs from NAMI, including Sharing Hope, Compartiendo Esperanza (Spanish-language), peer-led Support Groups, and the Community Health Equity Alliance, plus the Seize the Awkward campaign for youth. The release cited mental health prevalence: >1 in 5 adults and >1 in 7 youth affected annually, and that nearly 90% of people with depression report functional difficulties.
Axsome Therapeutics (NASDAQ: AXSM) will report third quarter 2025 financial results on Monday, November 3, 2025, before U.S. market open.
Management will host a conference call at 8:00 a.m. Eastern Time for results and a business update. Live participation is available via domestic dial-in (877) 405-1239, international +1 (201) 389-0851, or a webcast on the company’s Investors > Webcasts & Presentations page at www.axsome.com. A replay will be posted on the company website for approximately 30 days after the event.
Axsome Therapeutics (NASDAQ: AXSM) will present six posters showcasing clinical and real-world data across its neuroscience portfolio at Psych Congress 2025 in San Diego. The presentations cover multiple therapeutic areas including major depressive disorder, Alzheimer's disease agitation, narcolepsy, and obstructive sleep apnea.
Key presentations include data on Auvelity® for major depressive disorder, results from the ACCORD-2 Phase 3 trial of AXS-05 in Alzheimer's disease agitation, and findings from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy. Additional presentations will cover the ENCORE trial in narcolepsy, the CRESCENDO Survey analysis, and real-world data on solriamfetol in obstructive sleep apnea from the SURWEY study.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on CNS disorders, has announced its participation in six major investor conferences during September 2025. The company will engage in fireside chats at the Wells Fargo Healthcare Conference (Sept 3), Cantor Global Healthcare Conference (Sept 4), Morgan Stanley Global Healthcare Conference (Sept 8), Baird Global Healthcare Conference (Sept 10), and TD Cowen Novel Mechanisms Summit (Sept 17), followed by investor meetings at the Deutsche Bank Virtual BioPharm Corporate Day (Sept 18).
Live webcasts will be available for four of the presentations and can be accessed through Axsome's website, with replays available for approximately 30 days after each event.