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. reports news on its biopharmaceutical business focused on central nervous system disorders, including marketed medicines and late-stage neuroscience programs. Company updates commonly cover FDA actions, product revenue for AUVELITY, SUNOSI and SYMBRAVO, business results, investor presentations, and development activity in neurological and psychiatric conditions.
Recurring topics include AUVELITY for major depressive disorder and agitation associated with dementia due to Alzheimer’s disease, SUNOSI for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, migraine treatment commercialization, and pipeline work involving solriamfetol, AXS-12 and PDE10A inhibitor programs.
Axsome Therapeutics (NASDAQ: AXSM) will release its third quarter 2020 financial results on November 5, 2020, prior to the U.S. market opening. The management team will host a conference call at 8:00 AM Eastern Time to discuss these results and provide a business update. Axsome develops therapies for central nervous system disorders and has five clinical-stage candidates, including AXS-05 for major depressive disorder and AXS-07 for migraine. The company emphasizes the potential for accelerated approval of its products, pending successful clinical trials.
Axsome Therapeutics, Inc. (NASDAQ: AXSM) has secured a $225 million term loan facility with Hercules Capital, strengthening its balance sheet ahead of the commercial launches of AXS-05 for major depressive disorder and AXS-07 for migraine. This non-dilutive capital extends Axsome's cash runway into at least 2024. The loan includes an initial $60 million drawdown, with further funds contingent on product approvals and sales criteria. Interest starts at 9.15%, with maturity in October 2025. This financing will support Axsome's ongoing CNS product development.
Axsome Therapeutics (NASDAQ: AXSM) has secured a $225 million term loan facility with Hercules Capital to enhance its balance sheet ahead of major product launches. This non-dilutive funding extends its cash runway into at least 2024, supporting the commercial launches of AXS-05 for major depressive disorder and AXS-07 for migraine. Upon closing, Axsome drew $50 million and aims to access further tranches based on product approvals and sales criteria. The loan, maturing in October 2025, includes a variable interest rate currently at 9.15% and will aid in advancing its additional CNS pipeline.
Axsome Therapeutics (NASDAQ: AXSM) announced promising results from the MOMENTUM Phase 3 trial for AXS-07, an investigational oral medication for acute migraine treatment. AXS-07 showed a median time to pain relief nearly three times faster than rizatriptan (1.5 vs. 4.0 hours, p0.001). Additionally, only 21.2% of AXS-07 patients experienced pain relapse over 48 hours, compared to 45.2% with rizatriptan (p=0.001). AXS-07 demonstrated safety, with common adverse effects similar to placebo. The drug is protected by 44 patents until 2036, emphasizing its market potential.
Axsome Therapeutics (NASDAQ: AXSM) announced an expedited development plan for AXS-12, a novel treatment for narcolepsy, following a Breakthrough Therapy meeting with the FDA. The plan includes a Phase 3 trial to support an NDA filing, alongside data from the completed Phase 2 CONCERT trial. AXS-12 aims to reduce cataplexy attacks and improve patient cognitive function and daytime alertness. The initiation of the Phase 3 trial is expected in 1Q 2021, leveraging a large safety database from reboxetine. AXS-12 has already received Breakthrough Therapy designation from the FDA.
Axsome Therapeutics announces selected presentation of Phase 3 trial data for AXS-07 at the 2020 AAN Science Highlights, showcasing its efficacy in migraine treatment. The trial results will be unveiled on September 23, 2020, at 12:15 PM CT, following a competitive selection process among over 150 abstracts. AXS-07 combines meloxicam and rizatriptan, aiming for rapid and consistent migraine relief. The data could support future FDA approval, enhancing Axsome's position in the CNS disorder market.
Axsome Therapeutics (NASDAQ: AXSM) announced significant findings from the GEMINI Phase 3 trial of AXS-05, a novel oral NMDA receptor antagonist for major depressive disorder (MDD). The trial showed a rapid and statistically significant reduction in depressive symptoms, with AXS-05 demonstrating a 7.8 point reduction in the QIDS-SR-16 total score compared to 5.4 points for placebo (p=0.001). The clinical response rate was 53% for AXS-05 versus 33% for placebo at week 6 (p0.001). These results, presented at the , highlight the potential of AXS-05 as a new treatment option for MDD.
Axsome Therapeutics (NASDAQ: AXSM) announced the presentation of clinical data on AXS-05 for major depressive disorder (MDD) at the 33rd Congress of the European College of Neuropsychopharmacology (ECNP), held virtually from September 12-15, 2020. AXS-05 is an investigational oral NMDA receptor antagonist designed for MDD treatment. The poster presentation, titled 'Efficacy and safety of AXS-05', will feature insights from the Phase 3 GEMINI trial. AXS-05 is under development for multiple CNS disorders and has received FDA Breakthrough Therapy and Fast Track designations.
Axsome Therapeutics (NASDAQ: AXSM) announced its CEO, Herriot Tabuteau, will participate in a virtual fireside chat at the Morgan Stanley 18th Annual Global Healthcare Conference on September 17, 2020, at 10:15 AM ET. This event will be available via live webcast and archived on the Company’s website. Axsome focuses on developing innovative therapies for CNS disorders and has a portfolio of five clinical-stage candidates, including AXS-05 for major depressive disorder and AXS-07 for migraine treatment. For more information, visit www.axsome.com.
Axsome Therapeutics (NASDAQ: AXSM) will present at two investor conferences in September 2020. The Cantor Virtual Global Healthcare Conference is on September 15 at 9:20 AM ET, featuring a fireside chat with CEO Herriot Tabuteau. The H.C. Wainwright 22nd Annual Global Investment Conference is scheduled for September 14 at 10:30 AM ET, where Tabuteau will provide a corporate overview. Live webcasts for both events will be accessible on the company’s website.
Axsome focuses on innovative therapies for CNS disorders, with clinical candidates like AXS-05 and AXS-07 targeting major depressive disorder and migraines, respectively.