Welcome to our dedicated page for Axsome Therapeut news (Ticker: AXSM), a resource for investors and traders seeking the latest updates and insights on Axsome Therapeut stock.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a biopharmaceutical company focused on central nervous system (CNS) conditions, and its news flow reflects both commercial performance and clinical development across this neuroscience portfolio. On this page, readers can follow AXSM news related to its FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as updates on its late-stage and other development programs.
Company announcements frequently cover net product revenue for AUVELITY, SUNOSI, and SYMBRAVO, as reported in quarterly financial results and preliminary revenue updates. These releases, often furnished to the SEC via Form 8-K, provide insight into prescription trends, payer coverage metrics, and the contribution of each product to Axsome’s overall revenue base.
Axsome’s news also highlights key clinical and regulatory milestones. Examples include initiation of the FORWARD Phase 3 trial of AXS-14 in fibromyalgia, FDA acceptance and Priority Review of a supplemental New Drug Application for AXS-05 in Alzheimer’s disease agitation, and pre-NDA meeting outcomes supporting an NDA submission for AXS-12 in narcolepsy. Additional items describe progress of solriamfetol in multiple Phase 3 programs and the acquisition of AZD7325 for potential use in epilepsy.
Investors and followers of AXSM stock can use this news feed to monitor earnings releases, pipeline data presentations at scientific meetings, regulatory designations, business development transactions, and Axsome’s participation in healthcare and biopharma investor conferences. Bookmarking this page allows for efficient tracking of how Axsome advances its CNS portfolio and communicates with the market over time.
Axsome Therapeutics (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a fireside chat at the SVB Securities Global Biopharma Conference on February 15, 2023, at 8:40 a.m. ET. The event will provide insights into Axsome's developments in central nervous system (CNS) disorders therapies. A live webcast will be available on the company's website under the 'Webcasts & Presentations' section. Axsome is committed to providing innovative treatment options for CNS conditions with limited therapies. For more details, visit axsome.com.
Axsome Therapeutics (NASDAQ: AXSM) has announced a conference call on Feb. 27, 2023, at 8:00 a.m. ET to discuss its financial results for the fourth quarter and full year of 2022. The company will report these results before the U.S. markets open. Investors can access the call via a toll-free number or a live webcast on the company’s website. Following the event, a recording will be available for 30 days. Axsome focuses on developing therapies for central nervous system disorders with limited treatment options. The company emphasizes its commitment to improving patient care through innovative approaches.
Axsome Therapeutics (NASDAQ: AXSM) has reported significant advancements in cognitive and physical functioning due to its treatment AUVELITY® for major depressive disorder (MDD) in the recent EVOLVE trial. Improvements began at week 1 and persisted for 12 months, with mean changes in cognitive functioning scores of -2.0, -4.4, and -7.5 points from baseline to weeks 1, 2, and 6 respectively. Disability scores also decreased over the same period. The trial enrolled 146 patients with a generally well-tolerated safety profile, showcasing a promising option for MDD treatment amid high unmet medical needs.
Axsome Therapeutics announced promising results from the Phase 3 ACCORD trial for AXS-05, a treatment for agitation in Alzheimer’s patients. AXS-05 significantly delayed relapse time (hazard ratio 0.275, p=0.014) and prevented relapse compared to placebo (7.5% vs. 25.9%, p=0.018). Improvements in agitation were evident from Week 1 and observed by 66% of clinicians and 68% of caregivers at 2 weeks, rising to 86% and 89% at 5 weeks, respectively. This investigational therapy addresses a critical unmet need, as no FDA-approved treatments exist for Alzheimer’s agitation.
Axsome Therapeutics (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a virtual fireside chat at the 5th Annual Evercore ISI HealthCONx Conference on November 30, 2022, at 12:10 PM ET. The event can be accessed via a live webcast on the company’s website. Axsome focuses on developing novel therapies for central nervous system (CNS) disorders, aiming to improve treatment options and patient lives. The company may discuss forward-looking statements regarding clinical trials and product approvals.
Axsome Therapeutics (NASDAQ: AXSM) has announced that its CEO, Herriot Tabuteau, will participate in a fireside chat at the Guggenheim 4th Annual Immunology and Neurology Conference on November 15, 2022, at 10:45 AM ET. The event is set to take place at the St. Regis Hotel in New York City. Interested parties can view a live webcast and archived presentation on the company’s website.
Axsome specializes in developing innovative therapies for central nervous system disorders, aiming to improve treatment options for patients with limited alternatives.
Axsome Therapeutics reported Q3 2022 net sales of $16.8 million from Sunosi, marking a significant milestone since the product's acquisition. The company launched Auvelity on October 20, 2022, following FDA approval. Operating expenses rose, with R&D expenses at $14.9 million and SG&A at $40.9 million.
The net loss was $44.8 million or $(1.07) per share. Axsome maintains a strong cash position of $227.5 million, projected to fund operations into 2025. Key clinical trials and product candidates are progressing, with notable milestones ahead.
Axsome Therapeutics (NASDAQ: AXSM) announced the launch of AUVELITY™, a novel oral treatment for Major Depressive Disorder (MDD) in adults, coinciding with a ceremonial bell ringing at NASDAQ on October 27, 2022. AUVELITY is an NMDA receptor antagonist that combines dextromethorphan and bupropion, receiving Breakthrough Therapy designation from the FDA. Additionally, Axsome highlighted the relaunch of Sunosi, enhancing its position in the CNS therapy market. The company remains committed to advancing its robust pipeline of treatments for mental health conditions.
Axsome Therapeutics (NASDAQ: AXSM) will report its Q3 2022 financial results on November 7, 2022, before U.S. market opening. A conference call will take place at 8:00 AM ET for management to discuss results and provide business updates. Interested parties can join the call by dialing (877) 405-1239 or via a live webcast on the company’s website. Axsome focuses on developing novel CNS therapies, emphasizing its commitment to enhancing patient outcomes. Forward-looking statements pertain to potential market and regulatory challenges affecting product candidates.
Axsome Therapeutics has launched AUVELITY™, an innovative oral treatment for major depressive disorder (MDD) in adults, marked as the first NMDA receptor antagonist of its kind. Approved by the FDA on August 18, 2022, AUVELITY demonstrates rapid symptom relief, showing statistically significant improvement compared to placebo starting at one week. This breakthrough treatment addresses the urgent need for effective therapies in a population with over 20 million affected annually. Comprehensive patient support, including savings programs and telehealth services, are also available to facilitate access for patients and healthcare providers.