Axsome Therapeut Stock Price, News & Analysis

Axsome Therapeutics (NASDAQ:AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, announced that CEO Herriot Tabuteau and the management team will ring the NASDAQ opening bell on July 21, 2025. The ceremony coincides with their Frontiers in Brain Health R&D Day event.

The event highlights Axsome's progress in developing late-stage CNS product candidates and celebrates the recent U.S. launch of SYMBRAVO®. The company aims to transform clinical practice in brain health through its portfolio of marketed medicines and investigational treatments for CNS conditions. The bell ringing ceremony will be held at the Nasdaq MarketSite in Times Square, New York, starting at 9:20 a.m. ET.

Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, will release its Q2 2025 financial results on Monday, August 4, 2025, before U.S. markets open.

The company will host a conference call at 8:00 AM ET to discuss the results and provide business updates. Investors can join via phone or watch the webcast on Axsome's website, where a replay will be available for approximately 30 days.

Axsome Therapeutics (NASDAQ:AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, will host its Frontiers in Brain Health R&D Day on July 21, 2025 at 11:00 a.m. ET in New York City.

The event will showcase Axsome's late-stage CNS pipeline, featuring presentations from physician key opinion leaders discussing current neurology and psychiatry indications. The company's management team will provide detailed insights into their clinical development programs, followed by a Q&A session.

The R&D Day is specifically designed for institutional investors and sell-side analysts, with limited in-person attendance available through RSVP. A live webcast will be accessible to the public through the company's website.

Axsome Therapeutics (NASDAQ: AXSM) is joining the Alzheimer's disease advocacy community during Alzheimer's & Brain Awareness Month to highlight the growing impact of Alzheimer's disease in the US. The company emphasizes that over 7 million Americans now live with Alzheimer's, with projections showing an increase to 14 million by 2060. Research indicates that up to 45% of dementia cases may be linked to modifiable risk factors. The disease has risen from the 12th most burdensome disease in 1990 to the sixth in 2016 in terms of disability-adjusted life years. Axsome is collaborating with advocacy and patient communities to raise awareness and share resources, while also participating in scientific and medical conferences throughout the year.

Axsome Therapeutics (NASDAQ: AXSM) will present clinical data for SYMBRAVO® (meloxicam and rizatriptan) at the 67th Annual Scientific Meeting of the American Headache Society (AHS) from June 19-22, 2025, in Minneapolis. The presentations will showcase three key studies: the INTERCEPT trial analyzing SYMBRAVO's efficacy based on baseline migraine-associated disability, the MOVEMENT trial examining long-term effects on headache burden and quality of life, and the EMERGE trial investigating efficacy in patients with inadequate response to oral CGRP inhibitors. Notable researchers including Dr. Stewart Tepper from Dartmouth and Dr. Richard B. Lipton from Albert Einstein College of Medicine will lead the presentations.

Axsome Therapeutics (NASDAQ: AXSM) is supporting Migraine and Headache Awareness Month in June 2025 in collaboration with the Association of Migraine Disorders. The company is backing over 12 Miles for Migraine Run, Walk or Relax events nationwide and providing educational resources for migraine patients and their families. Migraine, affecting approximately 40 million Americans, is the second leading cause of disability worldwide. The condition causes debilitating headaches with symptoms including nausea and sensitivity to light and sound. Axsome is sharing resources from major migraine advocacy organizations, including the American Migraine Foundation's doctor finder, AMD's educational videos, CHAMP's financial assistance guides, and the National Headache Foundation's podcast.

Axsome Therapeutics (NASDAQ: AXSM) announced seven presentations at SLEEP 2025, focusing on their CNS treatments AXS-12 and solriamfetol. The presentations include two featured oral plenary sessions and multiple poster presentations taking place on June 11, 2025, in Seattle. The research covers various aspects including Phase 3 trial results of AXS-12 in narcolepsy (SYMPHONY and ENCORE trials), analysis of symptom burden in narcolepsy patients, and real-world studies of solriamfetol in treating excessive daytime sleepiness in patients with obstructive sleep apnea. Notable researchers presenting include Dr. Richard Bogan from the University of South Carolina and Dr. Michael Thorpy from the Montefiore Medical Center.

Axsome Therapeutics (NASDAQ: AXSM) has launched SYMBRAVO (meloxicam and rizatriptan), a novel prescription medication for acute migraine treatment in adults, now available in the United States. SYMBRAVO utilizes a multi-mechanistic approach targeting multiple brain pathways involved in migraine attacks, providing rapid pain relief within 2 hours and lasting up to 24 hours in some patients after a single dose. The launch addresses a significant unmet need, as migraine affects approximately 40 million Americans, with 63% of patients reporting dissatisfaction with current treatments. To support patient access, Axsome has introduced the SYMBRAVO On My Side program, offering savings for eligible commercially insured patients and comprehensive educational resources. The medication, powered by Axsome's patented MoSEIC technology, represents a new treatment option for the second leading cause of disability worldwide.

Axsome Therapeutics (NASDAQ: AXSM) received a Refusal to File (RTF) letter from the FDA regarding their New Drug Application for AXS-14 (esreboxetine) for fibromyalgia management. The FDA found the application incomplete, specifically citing issues with the second placebo-controlled trial's 8-week primary endpoint and flexible-dose paradigm. The first trial, using a 12-week endpoint and fixed-dose paradigm, was deemed adequate. Notably, both trials met their primary endpoints, and the FDA didn't question the positive results. In response, Axsome will conduct an additional controlled trial with a fixed-dose paradigm and 12-week primary endpoint, planned to start in Q4 2025. The drug aims to address approximately 17 million U.S. fibromyalgia patients' needs, having shown promising results in improving pain, function, and fatigue symptoms.