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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), a leading biopharmaceutical company specializing in CNS disorder treatments, announced it will report its Q2 2024 financial results on August 5, 2024, before U.S. markets open. The management will host a conference call at 8:00 a.m. ET to discuss the results and provide a business update. Investors can join the call via a toll-free number or access a live webcast through the company's website. A recording will be available for 30 days post-event.
Axsome Therapeutics (NASDAQ: AXSM) announced a settlement with Unichem Laboratories regarding patent litigation for Sunosi® (solriamfetol). The litigation arose after Unichem filed for FDA approval to market a generic version of Sunosi in the U.S. per an Abbreviated New Drug Application. The settlement allows Unichem to sell its generic version starting June 30, 2042, with possible earlier entry under specific conditions. Additionally, the date could be extended for pediatric exclusivity. The agreement will be reviewed by the U.S. Federal Trade Commission and the Department of Justice. Similar litigation with other parties continues in the District of New Jersey.
Axsome Therapeutics (NASDAQ: AXSM) announced its participation in the American Migraine Foundation's efforts for Migraine & Headache Awareness Month in June 2024. This initiative aims to raise awareness about unmet treatment needs for the 37 million Americans suffering from migraines, which cause significant physical, emotional, and economic impacts. The American Migraine Foundation emphasizes the importance of education, support, community, and research to improve patient outcomes and societal attitudes toward migraines. Notably, 70% of migraine sufferers are dissatisfied with current treatments, and nearly 80% are open to trying new therapies.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company specializing in central nervous system (CNS) disorders, announced its support for Alzheimer’s & Brain Awareness Month this June. The initiative aims to raise awareness about Alzheimer’s disease (AD), a progressive neurodegenerative disorder affecting nearly 7 million individuals in the U.S., a number that could double by 2060. Axsome's headquarters at One World Trade Center will be illuminated in purple on June 21, 2024, symbolizing AD awareness.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company specializing in therapies for CNS disorders, announced participation in two investor conferences. These events include the William Blair 44th Annual Growth Stock Conference on June 5 in Chicago, where CEO Herriot Tabuteau, MD, will present a corporate overview, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 12 in Miami Beach, where Axsome leadership will conduct investor meetings. A live webcast of the William Blair presentation will be available on the company's website.
On May 29, 2024, Axsome Therapeutics (NASDAQ: AXSM) announced significant findings on solriamfetol at the SLEEP 2024 conference, held from June 1-5, 2024, in Houston, Texas. The presentations highlighted solriamfetol's positive effects on cognitive function in patients with Obstructive Sleep Apnea (OSA) and narcolepsy, particularly those experiencing Excessive Daytime Sleepiness (EDS). Key findings from the SHARP study, led by Professor Hans Van Dongen, demonstrated improvements in executive function, memory, and processing speed. Presentations included two oral plenary sessions and multiple poster sessions, emphasizing solriamfetol's impact on various cognitive metrics and real-world applications.
Axsome Therapeutics (NASDAQ: AXSM) will present data from its CNS disorder therapies at the American Society of Clinical Psychopharmacology Annual Meeting from May 28-31, 2024, in Miami Beach, Florida. Key presentations include:
1. Post-hoc analyses of Auvelity® demonstrating significant improvements in anhedonic and daily functioning in major depressive disorder (MDD) patients.
2. Data on AXS-05's clinical profile for treating Alzheimer's disease agitation, showcasing promising results from the Phase 2/3 development program.
3. Findings on Solriamfetol's efficacy in enhancing cognitive performance in sleep apnea patients from both preclinical and clinical studies.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) will be represented by Chief Executive Officer, Dr. Herriot Tabuteau, at two upcoming investor conferences. The company focuses on developing novel therapies for central nervous system disorders. The presentations will take place at the RBC Capital Markets 2024 Global Healthcare Conference on May 14 and the Bank of America 2024 Healthcare Conference on May 16. Investors can watch the events live on the company's website.
Axsome Therapeutics reported strong financial results for the first quarter of 2024, with total net product revenue of $75.0 million, representing significant year-over-year growth. The company announced positive Phase 3 trial results for AXS-12 in narcolepsy, with other key pipeline programs progressing well. However, the increase in research and development expenses, higher selling, general, and administrative expenses, and a net loss of $68.4 million for the quarter are some challenges highlighted in the financial report.
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