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 seven presentations on AXS-12 and solriamfetol at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society. The presentations include data from the SYMPHONY Phase 3 trial of AXS-12 in narcolepsy, findings from the CRESCENDO patient survey on unmet needs in type 1 narcolepsy, and previously reported data on solriamfetol showing improvement in cognitive function in patients with excessive daytime sleepiness associated with OSA and narcolepsy.
The presentations cover various aspects of sleep disorders, including treatment outcomes, symptom burden, quality of life, and cognitive effects. Notable presentations include topline results from the SYMPHONY trial, real-world use of solriamfetol in patients with anxiety or depression, and effects of solriamfetol on cognition in obstructive sleep apnea patients with excessive daytime sleepiness.
Axsome Therapeutics (NASDAQ: AXSM) announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for AXS-07, a treatment for acute migraine. The FDA has classified it as a Class 2 resubmission and set a PDUFA action goal date of January 31, 2025. This development marks a significant milestone in Axsome's efforts to bring a new migraine treatment to market. The acceptance of the NDA resubmission indicates progress in addressing previous FDA concerns and moves AXS-07 closer to potential approval. Investors and patients alike will be closely watching the outcome, as a successful approval could impact both Axsome's market position and migraine treatment options.
Axsome Therapeutics (NASDAQ: AXSM), a biopharmaceutical company focused on central nervous system (CNS) disorders, has announced its participation in four major investor conferences in September 2024:
1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 4 in New York (presentation at 4:50 p.m. ET)
2. Wells Fargo Healthcare Conference on September 5 in Boston (investor meetings)
3. Baird 2024 Global Healthcare Conference on September 11 in New York (presentation at 8:30 a.m. ET)
4. Cantor Global Healthcare Conference on September 18 in New York (presentation at 9:45 a.m. ET)
Live webcasts of the presentations at the Morgan Stanley and Cantor conferences will be available on Axsome's website, with replays accessible for approximately 30 days after each event.
Axsome Therapeutics (NASDAQ: AXSM) has announced an agreement with Sandoz Inc. to dismiss the patent litigation related to Axsome's product Sunosi® (solriamfetol). The litigation was pending in the U.S. District Court for the District of New Jersey and stemmed from Sandoz's submission of an Abbreviated New Drug Application (ANDA) to the FDA, seeking approval to market a generic equivalent of Sunosi in the United States. As part of the agreement, Sandoz has withdrawn its ANDA for a generic equivalent of Sunosi, resulting in the dismissal of the litigation without prejudice.
Axsome Therapeutics (NASDAQ: AXSM) reported strong Q2 2024 financial results, with total net product revenue of $87.2 million, up 87% year-over-year. Auvelity sales grew 135% to $65.0 million, while Sunosi revenue increased 16% to $22.1 million. The company resubmitted its NDA for AXS-07 in migraine and expects to submit an NDA for AXS-14 in fibromyalgia in Q3 2024. Axsome anticipates topline results from multiple Phase 3 trials in H2 2024, including studies of AXS-05 in Alzheimer's disease agitation and solriamfetol in ADHD. Despite strong revenue growth, the company reported a net loss of $79.3 million for Q2 2024, compared to $67.2 million in Q2 2023, primarily due to increased R&D and SG&A expenses.
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.