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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 (NASDAQ: AXSM) announced that CEO Herriot Tabuteau will participate in a fireside chat at the 22nd Annual Needham Virtual Healthcare Conference on April 20, 2023, at 1:30 p.m. ET. This event will provide insights into the company's novel therapies for central nervous system disorders. Interested parties can access a live webcast and an archive of the discussion on the Investors section of Axsome's website. The company focuses on developing innovative treatments for CNS conditions, aiming to enhance patient care. Forward-looking statements in the release highlight potential future developments, including risks and uncertainties surrounding product success and regulatory approvals.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) has announced a conference call scheduled for May 8, 2023, at 8:00 a.m. Eastern Time to discuss its financial results for the first quarter of 2023. This call will be held prior to the opening of U.S. financial markets and will also provide a business update. Interested participants can access the live conference call by dialing (877) 405-1239 or through a webcast on the company’s website. Axsome specializes in developing therapies for central nervous system (CNS) disorders and is focused on transforming treatment options with novel approaches. The company highlights its commitment to improve patients' lives by offering new therapeutic avenues for physicians.
Axsome Therapeutics (NASDAQ: AXSM) announced CEO Herriot Tabuteau will join a fireside chat at Cowen's 43rd Annual Health Care Conference on March 8, 2023, at 2:10 p.m. ET in Boston. The event aims to showcase Axsome's innovative therapies for CNS disorders. Interested parties can access a live webcast of the discussion through the company's website.
Axsome focuses on developing novel treatment options for CNS conditions with limited remedies available. The company emphasizes its commitment to improving patient care and advancing drug development.
Axsome Therapeutics reported fourth quarter 2022 net product sales of $24.4 million, with Auvelity generating $5.2 million and Sunosi $19.2 million. The company launched Auvelity on October 19, 2022, bolstered by a new licensing agreement for Sunosi in Europe, worth $66 million upfront and potential milestones of $101 million. Net loss for Q4 was $61.2 million or $(1.41) per share, compared to a loss of $34 million in Q4 2021. Despite increased operational costs, Axsome boasts over $300 million in cash, positioning itself well for future growth amidst ongoing R&D for CNS disorders.
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.
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