Axsome Therapeut Stock Price, News & Analysis

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.

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.