Axsome Therapeutics, Inc - AXSM STOCK NEWS

Axsome Therapeutics (NASDAQ: AXSM) will have CEO Herriot Tabuteau participate in a virtual fireside chat at the Cowen 2nd Annual Novel Mechanisms in Neuropsychiatry Summit on September 19, 2022, at 12:05 PM ET. The event can be accessed via live webcast and archived on their website. Axsome focuses on developing innovative therapies for central nervous system disorders, aiming to provide effective treatment options for patients with limited existing therapies. For more details, visit axsome.com.

Axsome Therapeutics (NASDAQ: AXSM) has initiated the ADVANCE-2 trial, enrolling its first patient for AXS-05, targeting Alzheimer’s disease agitation. This Phase 3 study aims to investigate the efficacy and safety of AXS-05 compared to a placebo, involving about 350 participants over five weeks, with the Cohen-Mansfield Agitation Inventory as the primary measure. AXS-05, an NMDA receptor antagonist, holds FDA Breakthrough Therapy designation for treating agitation. Currently, no FDA-approved treatments exist for this condition, highlighting the potential impact of AXS-05.

Axsome Therapeutics (NASDAQ: AXSM) announced a post-hoc analysis showing that its drug Sunosi® (solriamfetol) effectively reduces excessive daytime sleepiness (EDS) in patients with and without a history of depression. This analysis, derived from two randomized, placebo-controlled trials, confirms a significant prevalence of depression among EDS patients. Sunosi is the only dual-acting dopamine and norepinephrine reuptake inhibitor approved for improving wakefulness in adults with EDS due to narcolepsy or obstructive sleep apnea.

Axsome Therapeutics (NASDAQ: AXSM) announced participation by CEO Herriot Tabuteau in a fireside chat at the Morgan Stanley 20th Annual Global Healthcare Conference on September 12, 2022, at 11:40 AM ET. The event will take place at the Sheraton Times Square, New York. A live webcast will be available on the Company’s website under the ‘Webcasts & Presentations’ section. Axsome focuses on innovative therapies for central nervous system disorders, committed to improving patient outcomes through new treatment options.

Axsome Therapeutics (NASDAQ: AXSM) has announced the enrollment of the first patient in the Phase 3 EMERGE trial for AXS-07, targeting acute migraine treatment in patients unresponsive to oral CGRP inhibitors. This multicenter trial will treat approximately 100 patients for up to eight weeks, assessing the drug's efficacy and safety with co-primary endpoints focusing on pain relief and the absence of the most bothersome symptom post-dosing. AXS-07 is a novel investigational medicine designed to provide rapid and consistent migraine relief.

Axsome Therapeutics announced the FDA's approval of AUVELITY, the first rapid-acting oral treatment for major depressive disorder (MDD) in over 60 years. This innovative medication, which combines dextromethorphan and bupropion, demonstrates statistically significant improvement in depressive symptoms starting at one week compared to placebo. AUVELITY received FDA Breakthrough Therapy designation and will be available in the U.S. by Q4 2022. Clinical trials showed sustained efficacy with a favorable safety profile, addressing a critical need for effective MDD treatments amid rising cases.

Axsome Therapeutics reported its Q2 2022 financial results, showcasing first commercial sales of Sunosi, generating approximately $8.8 million from May 9 to June 30, 2022. The company anticipates key FDA actions this quarter regarding its NDA for AXS-05 in major depressive disorder and plans to re-submit NDA for AXS-07 in migraine. Axsome's R&D expenses increased to $15.8 million, while SG&A expenses rose to $31.2 million, contributing to a net loss of $41.4 million or $(1.06) per share. The company maintains a cash balance of $73.4 million.

Axsome Therapeutics (NASDAQ: AXSM) will report its Q2 2022 financial results on August 9, 2022, before U.S. market opening. A conference call is scheduled for 8:00 AM ET to discuss these results and provide a business update. Axsome is focused on developing innovative therapies for CNS disorders, showcasing its commitment to transform treatment options in this field. Investors can access the conference call via a toll-free number or through a live webcast on the company's website, with a recording available for 30 days post-event.

Axsome Therapeutics (NASDAQ: AXSM) hosted a virtual event on June 28, 2022, to update investors on Sunosi® (solriamfetol), the first dual-acting DNRI approved for excessive daytime sleepiness due to narcolepsy or obstructive sleep apnea. Key opinion leaders discussed clinical aspects and future indications of Sunosi, while management shared commercial and development strategies. Sunosi received FDA approval on March 20, 2019, and has orphan drug designation for narcolepsy, indicating potential growth in this market segment.