Axsome Therapeutics, INC 8-K filings

Axsome Therapeutics announced robust second quarter 2026 financial results, showcasing 46% year-over-year revenue growth and significant advancements in its CNS pipeline.

Axsome Therapeutics announced the FDA has accepted its New Drug Application for AXS-12 (reboxetine) for treating cataplexy in narcolepsy, with a target action date of May 1, 2027.

Axsome Therapeutics has implemented a new Executive Severance and Change in Control Plan to formalize benefits for key employees.

Axsome Therapeutics stockholders approved all proposals at the 2026 Annual Meeting, including director elections and executive compensation.

Axsome Therapeutics announced the resolution of all patent litigation concerning its product SUNOSI (solriamfetol), granting generic entry rights starting in 2040.

Axsome Therapeutics reported strong Q1 2026 results with 57% YoY revenue growth, driven by AUVELITY and SUNOSI, and provided updates on its expanding CNS pipeline and new indications.

The FDA has approved Axsome Therapeutics' AUVELITY for the treatment of agitation associated with dementia due to Alzheimer's disease.

Axsome Therapeutics has acquired exclusive global rights to balipodect, a selective PDE10A inhibitor, to develop for schizophrenia and Tourette syndrome.

Axsome Therapeutics announced robust financial results for Q4 and full year 2025, driven by strong product sales growth and significant pipeline advancements, including a Priority Review for AXS-05.

Axsome Therapeutics has reached a settlement with Alkem Laboratories, resolving patent litigation over its product SUNOSI and setting a generic entry date.

Axsome Therapeutics announced preliminary fourth quarter and full year 2025 net product revenues, showing significant annual growth driven by AUVELITY, SUNOSI, and SYMBRAVO.

Axsome Therapeutics announced FDA Priority Review for AXS-05 in Alzheimer's agitation and confirmed its AXS-12 narcolepsy NDA submission is on track for January 2026.

Axsome Therapeutics announced robust third-quarter 2025 financial results, driven by significant revenue growth across its marketed products and key advancements in its neuroscience pipeline.

Axsome Therapeutics received a Paragraph IV Notice from Apotex Inc. regarding a generic version of its Symbravo drug.

Axsome Therapeutics announced robust second quarter 2025 financial results, driven by significant revenue growth from AUVELITY and SUNOSI, alongside key advancements in its neuroscience pipeline.

Axsome Therapeutics, Inc. announced the commercial availability of SYMBRAVO (meloxicam and rizatriptan) in the United States for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach.

Axsome Therapeutics, Inc. announced that its stockholders approved all four proposals, including the election of a Class I director, the 2025 Long-Term Incentive Plan, the ratification of Deloitte & Touche LLP as auditors, and executive compensation, at its Annual Meeting held on June 6, 2025.

Axsome Therapeutics announced it received a Refusal to File letter from the FDA for its New Drug Application for AXS-14 for fibromyalgia, necessitating an additional controlled trial.

Axsome Therapeutics announced a settlement agreement with Hetero Labs Ltd. resolving patent litigation for its product SUNOSI, granting Hetero a license to sell a generic version starting in 2040.

Axsome Therapeutics enters into a $570 million term loan and revolving credit facility with Blackstone, retiring its previous debt with Hercules Capital and strengthening its financial position.

Axsome Therapeutics announces a successful first quarter in 2025, marked by significant revenue growth, regulatory progress, and pipeline advancements.

Axsome Therapeutics' Phase 3 PARADIGM trial of solriamfetol in MDD showed no statistically significant improvement in the overall patient population, but demonstrated promising results in a subgroup with severe excessive daytime sleepiness (EDS), leading to plans for a Phase 3 trial in MDD patients with EDS.

Axsome Therapeutics announces positive results from its Phase 3 FOCUS trial of solriamfetol in adults with ADHD, demonstrating statistically significant improvements in ADHD symptoms and disease severity compared to placebo.

Axsome Therapeutics has reached a settlement agreement with Hikma Pharmaceuticals USA, resolving patent litigation concerning Axsome's Sunosi (solriamfetol) product.

Axsome Therapeutics announces positive pre-NDA meeting feedback from the FDA, supporting a supplemental NDA submission for AXS-05 in treating agitation associated with Alzheimer's disease.

Axsome Therapeutics announces positive financial results for 2024, driven by strong commercial growth and pipeline advancements, including FDA approval of Symbravo and progress in clinical trials.

Axsome Therapeutics and Teva Pharmaceuticals have reached a settlement resolving all patent litigation related to Axsome's AUVELITY product, granting Teva a license to sell a generic version no earlier than 2038.

Axsome Therapeutics announces FDA approval of SYMBRAVO (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults, offering a novel multi-mechanistic approach.

Axsome Therapeutics reports robust preliminary net product revenue for 2024, driven by Auvelity and Sunosi sales, and highlights progress in its clinical pipeline.

Axsome Therapeutics reports successful completion of its Phase 3 clinical program for AXS-05 in Alzheimer's disease agitation, with the ACCORD-2 trial meeting its primary endpoint and a New Drug Application planned for the second half of 2025.