Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. announced it will release its financial results for the second quarter of 2026 on Monday, August 10, 2026, before U.S. financial markets open. Following the release, the company's management will host a conference call at 8:00 a.m. Eastern Time to discuss the results and provide a business update. Investors can access the live webcast via the company's website or participate by phone.

Axsome Therapeutics announced the dosing of the first patient in its FOCUS-2 Phase 3 trial, evaluating solriamfetol for treating attention deficit hyperactivity disorder (ADHD) in children aged 6 to less than 12 years. This randomized, double-blind, placebo-controlled trial will enroll approximately 468 patients over 6 weeks, with the primary endpoint being the change in ADHD-RS-5 total score. This new trial complements the previously initiated FOCUS-3 Phase 3 trial for adolescents with ADHD, expanding the potential market for solriamfetol, which is a DNRI, TAAR1 agonist, and 5-HT1A agonist.

Axsome Therapeutics announced that the first patient has been dosed in the FOCUS-3 Phase 3 trial. This trial is evaluating solriamfetol as a treatment for adolescents aged 12 to less than 18 years with attention deficit hyperactivity disorder (ADHD). The randomized, double-blind, placebo-controlled study will enroll approximately 468 patients, assessing efficacy and safety over 6 weeks with the primary endpoint being the change in ADHD-RS-5 total score.

Axsome Therapeutics announced presentations of new data on its drug candidates AXS-12 and solriamfetol at the SLEEP 2026 annual meeting. The presentations include cognitive and functional outcomes from the Phase 3 ENCORE trial of AXS-12 in narcolepsy with cataplexy, and a post-hoc analysis of Phase 3 trials for solriamfetol in excessive daytime sleepiness. Additionally, a subgroup analysis from the CRESCENDO survey on symptom burden and quality of life in narcolepsy patients with residual cataplexy will be presented.

Axsome Therapeutics, Inc. has adopted an Executive Severance and Change in Control Plan, effective June 5, 2026. This plan supersedes all prior severance arrangements and provides benefits to certain key employees, including named executive officers, upon qualifying termination events. The plan categorizes participants into three tiers, with varying severance benefits depending on whether the termination occurs outside or during a Change in Control period, including cash payments, COBRA premiums, and accelerated equity vesting.

Axsome Therapeutics, Inc. held its 2026 Annual Meeting of Stockholders on June 5, 2026. Stockholders elected Mark Saad and Susan Mahony, Ph.D., MBA, as Class II directors to serve until the 2029 annual meeting. Additionally, the appointment of Deloitte & Touche LLP as the independent registered public accounting firm for 2026 was ratified, and the compensation of named executive officers was approved on a non-binding advisory basis. Approximately 85.10% of eligible shares were represented at the meeting, constituting a quorum.

Axsome Therapeutics announced the presentation of new SYMBRAVO® data at the American Headache Society (AHS) 68th Annual Scientific Meeting. The presentations highlight SYMBRAVO's efficacy and safety for the acute treatment of migraine. Key data includes post-hoc composite efficacy and return to function analysis from the MOMENTUM trial, comparative efficacy against gepants, and sustained pain relief from MOMENTUM and MOVEMENT trials.

Axsome Therapeutics announced the resolution of all patent litigation concerning its product SUNOSI (solriamfetol). The company settled with the last remaining first-to-file generic applicant, granting five companies the right to market generic versions of SUNOSI. Generic sales are permitted to commence on or after September 1, 2040, if pediatric exclusivity is secured, or March 1, 2040, if not. The agreement will undergo review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

Axsome Therapeutics, Inc. is highlighting its commitment to the migraine community by supporting educational initiatives during Migraine and Headache Awareness Month in June. The company is backing the first annual "Headache in the City" campaign by the Headache Alliance on June 15 in New York City. Additionally, Axsome's New York City headquarters at One World Trade Center will be lit in purple on June 4 to promote awareness efforts, and the company is sharing resources from leading migraine advocacy organizations.

Axsome Therapeutics announced its participation in five upcoming investor conferences and a virtual CNS Day throughout June 2026. The company will hold fireside chats at the William Blair, Jefferies, Goldman Sachs, and Oppenheimer conferences, as well as the UBS Virtual CNS Day. Live webcasts of these presentations will be available on the company's investor relations website, with replays accessible for approximately 30 days following each event.