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Axsome Therapeutics, Inc. (NASDAQ: AXSM) is a leading biopharmaceutical company dedicated to developing innovative therapies for the treatment of central nervous system (CNS) disorders. Headquartered in New York City, Axsome's mission is to address unmet medical needs and improve the lives of patients suffering from CNS conditions.
The company's portfolio includes a mix of clinical-stage and research-stage product candidates, with a primary focus on CNS disorders such as depression, migraine, narcolepsy, and Alzheimer's disease. Axsome's pipeline features notable candidates like AXS-05 for major depressive disorder, AXS-07 for migraine, AXS-12 for narcolepsy, and AXS-14 for fibromyalgia. These therapies are being developed to provide novel treatment options where current solutions are limited or inadequate.
Axsome manages its business as a single operating segment, emphasizing the development and delivery of groundbreaking CNS therapies. The company has made significant strides in advancing its clinical programs, with several candidates progressing through various stages of clinical trials. Recent achievements include positive data readouts from clinical studies and successful end-of-phase meetings with regulatory bodies, positioning Axsome closer to potential market approvals.
Financially, Axsome maintains a solid foundation through strategic collaborations, public offerings, and partnerships. These financial maneuvers have enabled sustained investment in research and development, essential for driving innovation and bringing new therapies to market.
Axsome's commitment to transforming the treatment landscape for CNS disorders is underscored by its active engagement with the medical community, participation in scientific conferences, and continuous updates to investors and stakeholders. The company’s proactive communication strategy ensures transparency and keeps all interested parties informed about ongoing developments.
For the latest updates, investors and media can reach out to Mark Jacobson, Chief Operating Officer, or Darren Opland, Director of Corporate Communications, at Axsome's headquarters in New York City. More information is available on the company’s website, www.axsome.com.
Axsome Therapeutics has entered an exclusive license agreement with Pharmanovia for the commercialization of Sunosi® (solriamfetol) in Europe and MENA. Axsome will receive an upfront payment of $66 million and may earn up to $101 million in sales-based milestones. Pharmanovia will handle all ongoing clinical studies, including studies for pediatric patients. Sunosi, a dual-acting dopamine and norepinephrine reuptake inhibitor, enhances wakefulness for adults with excessive daytime sleepiness (EDS) linked to narcolepsy or obstructive sleep apnea. The drug was approved by the European Medicines Agency in 2020, demonstrating superiority in clinical studies.
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.