Axsome Therapeut - AXSM STOCK NEWS

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.

Axsome Therapeutics (NASDAQ: AXSM) announced a virtual event on June 28, 2022, at 9:00 AM EDT to update investors on Sunosi® (solriamfetol), a dual-acting dopamine and norepinephrine reuptake inhibitor. Sunosi is the first medication approved for improving wakefulness in adults with excessive daytime sleepiness (EDS) due to narcolepsy or obstructive sleep apnea (OSA). The event will feature clinical insights from physician experts and covers commercial activities. The live webcast can be accessed through Axsome's website, with a replay available for 30 days.

Axsome Therapeutics announced positive results from the GEMINI Phase 3 trial of AXS-05 for major depressive disorder (MDD). The treatment showed rapid and significant improvement in anhedonia symptoms, with a notable decrease on the MADRS anhedonia subscale compared to placebo (-9.70 vs -7.22 points; p=0.001). Improvements were observed from the first week of treatment. AXS-05 is a novel NMDA receptor antagonist and is under FDA review for MDD. These findings were presented at the ASCP 2022 Annual Meeting.

Axsome Therapeutics announced positive long-term results from the EVOLVE trial of AXS-05, focusing on major depressive disorder (MDD). The study demonstrated significant, sustained improvements in depressive symptoms, anxiety, and overall functioning over 12 months. Key statistics include a 24.5-point improvement in the MADRS score and 68% remission rate at 12 months. AXS-05 showed a favorable safety profile, consistent with earlier trials. This presentation was part of the American Society of Clinical Psychopharmacology Annual Meeting, highlighting AXS-05's potential as an effective treatment for patients with treatment-resistant depression.