Every 8-K that Axsome Therapeut (AXSM) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AXSM and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AXSM filings page.
Axsome Therapeutics reported strong growth for the three months ended June 30, 2026, with total net product revenue of $218.4 million, up 46% from $150.0 million a year earlier. AUVELITY led with $180.3 million in net product sales, a 51% year-over-year increase, while SUNOSI generated $35.8 million in net product revenue, up 20%, and SYMBRAVO reached $2.3 million, up 461%.
Despite the revenue growth, Axsome recorded a net loss of $51.3 million (vs. $48.0 million), or $(0.99) per share, driven largely by a 60% rise in SG&A expenses to $208.1 million as the company expanded commercialization activities, including AUVELITY’s June launch for agitation in Alzheimer’s disease. R&D expenses declined modestly to $46.2 million. Cash and cash equivalents totaled $319.9 million at June 30, 2026, compared with $322.9 million at year-end 2025, and Axsome states this cash is sufficient to fund operations into cash flow positivity under its current plan. Strategically, the NDA for AXS-12 in narcolepsy was accepted with a PDUFA target action date of May 1, 2027, multiple Phase 3 solriamfetol trials in ADHD, binge eating disorder, and shift work disorder are underway, and management highlights an industry-leading neuroscience pipeline and significant long-term commercial potential.
Axsome Therapeutics announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application (NDA) for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of May 1, 2027 and indicated it does not currently plan to hold an advisory committee meeting on the application.
AXS-12 is described as a highly selective and potent norepinephrine reuptake inhibitor and cortical dopamine modulator under development for narcolepsy and has U.S. Orphan Drug Designation. Narcolepsy is characterized by excessive daytime sleepiness and cataplexy, which occurs in an estimated 70% of patients and is linked to a 1.5-fold higher mortality rate.
Axsome Therapeutics, Inc. approved a new Executive Severance and Change in Control Plan that standardizes severance protection for key leaders, effective on June 5, 2026. The plan covers the CEO, other Section 16 officers, and vice presidents and above under three tiers.
For involuntary terminations outside a change in control period, Tier 1 participants receive 18 months of base salary and COBRA premiums, Tier 2 receive 12 months, and Tier 3 receive 6 months, generally paid over time. During a defined change in control period, cash severance increases to 24, 18, or 9 months of base salary by tier, with additional target bonus coverage.
In a change in control termination, 100% of unvested time-based equity vests, and performance-based awards vest at 100% of target. The new plan replaces prior severance arrangements, except where specifically preserved.
Axsome Therapeutics, Inc. reported the results of its 2026 Annual Meeting of Stockholders held on June 5, 2026. Stockholders elected Mark Saad and Susan Mahony as Class II directors to serve until the 2029 annual meeting and until their successors are elected and qualified. They also ratified the appointment of Deloitte & Touche LLP as independent registered public accounting firm for the year ending December 31, 2026. In addition, stockholders approved, on a non-binding advisory basis, the compensation of the Company’s named executive officers. A quorum was present, with about 85% of shares entitled to vote represented in person or by proxy.
Axsome Therapeutics, Inc. has resolved all patent litigation related to its wake-promoting therapy SUNOSI (solriamfetol). The disputes stemmed from Abbreviated New Drug Applications filed by companies seeking to market generic versions of SUNOSI in the United States.
Under a settlement with the only remaining first-to-file generic applicant, Axsome will grant five companies the right to sell generic SUNOSI beginning on or after September 1, 2040 if pediatric exclusivity is granted, or on or after March 1, 2040 if pediatric exclusivity is not granted, in each case subject to U.S. Food and Drug Administration approval and customary conditions. Axsome states that no other SUNOSI patent litigation remains pending and will submit the settlement agreement to the Federal Trade Commission and the Department of Justice for review.
Axsome Therapeutics reported first-quarter 2026 results with total net product revenue of $191.2M, up 57% year over year. Growth was led by AUVELITY, which generated $153.2M in net product revenue, a 59% increase, while SUNOSI contributed $33.9M and SYMBRAVO $4.1M.
Total operating expenses rose as Axsome expanded commercial efforts and R&D, including pre-launch spending for AUVELITY’s new indication and pipeline development. The company posted a net loss of $64.5M, or $1.26 per share, and ended March 31, 2026 with cash and cash equivalents of $305.1M.
AUVELITY received U.S. FDA approval for agitation associated with dementia due to Alzheimer’s disease, with a U.S. commercial launch planned for June 2026. Axsome also highlighted a broad late-stage neuroscience pipeline, including an NDA submission for AXS-12 in narcolepsy and multiple Phase 3 programs for solriamfetol.
Axsome Therapeutics announced that the U.S. Food and Drug Administration approved AUVELITY (dextromethorphan HBr/bupropion HCl) for the treatment of agitation associated with dementia due to Alzheimer’s disease. This makes Auvelity a first-in-class oral therapy for this indication, targeting NMDA and sigma‑1 receptors.
The approval follows Phase 3 ADVANCE-1 and ACCORD-2 trials, where Auvelity showed statistically significant improvement in agitation symptoms versus placebo and a longer time to relapse in responders. Agitation affects up to 76% of Alzheimer’s patients in a population of more than 7 million Americans, highlighting the clinical need addressed by this new indication.
Axsome Therapeutics entered into an asset purchase agreement with Takeda to obtain exclusive global commercial, development, and manufacturing rights to balipodect (TAK-063), a novel, oral, selective PDE10A inhibitor. Axsome plans to develop balipodect for schizophrenia and Tourette syndrome and to start Phase 3 trial-enabling activities for schizophrenia in 2026.
Balipodect has completed a 164-patient proof-of-concept Phase 2 trial in schizophrenia and has shown a favorable safety and tolerability profile in clinical studies in over 360 individuals. Takeda received an upfront payment and may receive additional development, regulatory, and commercial milestone payments, plus royalties on potential global net sales.
Axsome Therapeutics reported strong growth for the fourth quarter and full year 2025, with total net product revenue of $196.0 million in Q4 and $638.5 million for the year, up 65% and 66% from 2024. Growth was led by AUVELITY with 2025 sales of $507.1 million and SUNOSI with $124.8 million, plus initial SYMBRAVO contributions of $6.6 million.
The company’s net loss narrowed to $183.2 million in 2025 from $287.2 million in 2024, despite higher SG&A spending of $570.6 million to support commercialization. Cash and cash equivalents were $322.9 million as of December 31, 2025.
Axsome highlighted a rich CNS pipeline, including Priority Review for its sNDA for AXS-05 in Alzheimer’s disease agitation with a PDUFA target date of April 30, 2026, an NDA submission for AXS-12 in narcolepsy planned this quarter, multiple Phase 3 solriamfetol trials, and the newly acquired epilepsy candidate AXS-17.
Axsome Therapeutics has entered into a settlement agreement with Alkem Laboratories resolving U.S. patent litigation over Axsome’s wake‑promoting drug SUNOSI (solriamfetol). The case arose after Alkem filed an Abbreviated New Drug Application seeking approval to market a generic SUNOSI in the United States.
Under the settlement, Axsome will grant Alkem a license to sell its generic SUNOSI beginning on or after September 1, 2040 if pediatric exclusivity is granted for SUNOSI, or on or after March 1, 2040 if no pediatric exclusivity is granted, in each case subject to FDA approval and customary conditions. The settlement will be submitted to the FTC and DoJ for review, and Axsome notes that similar patent litigation against another party regarding SUNOSI remains pending in the same court.
Axsome Therapeutics, Inc. filed a Form 8-K to report that it issued a press release titled “Axsome Therapeutics Provides Preliminary Fourth Quarter and Full Year 2025 Net Product Revenue.” The company is furnishing the press release as Exhibit 99.1 under Item 2.02, covering results of operations and financial condition, and also referencing it under Item 8.01 as an other event.
The company specifies that the information in Item 2.02, including Exhibit 99.1, is being furnished rather than filed, so it is not subject to liability under Section 18 of the Exchange Act and is not incorporated by reference into other SEC filings unless specifically stated. The exhibit list confirms the press release and the related cover page data file as the primary attachments.
Axsome Therapeutics furnished a press release announcing financial results for the three months ended September 30, 2025, along with an operations update. The release is attached as Exhibit 99.1 and, under General Instruction B.2, is furnished and not deemed filed. The company also filed an updated corporate presentation as Exhibit 99.2 and posted it to its website.
Axsome Therapeutics reports that Apotex has filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market a generic version of Symbravo, a meloxicam‑rizatriptan benzoate product. Axsome received a Paragraph IV certification notice from Apotex, which is a formal notification tied to generic drug applications. The company states that it plans to respond to this notice in due course, indicating the start of a potential patent and exclusivity challenge to Symbravo.