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 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, p<0.001). 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 (p<0.001). These results, presented at the ECNP Congress, 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.
Axsome Therapeutics announced progress in the development of AXS-05 for the treatment of agitation in Alzheimer's disease following a Breakthrough Therapy meeting with the FDA. The completed ADVANCE-1 trial confirms pivotal status, requiring only one additional Phase 3 efficacy trial for NDA submission. This trial, planned for 4Q 2020, will utilize a randomized-withdrawal design. Currently, there are no approved treatments for AD agitation, underscoring the importance of AXS-05 in addressing this significant health issue.
Axsome Therapeutics (AXSM) announced the presentation of efficacy and safety data for AXS-12, a novel treatment for narcolepsy, during the virtual 34th Annual SLEEP Meeting from August 27 to 30, 2020. AXS-12, a selective norepinephrine reuptake inhibitor, has received FDA Breakthrough Therapy and Orphan Drug designations. The trial results will be detailed in a poster titled Efficacy and Safety of AXS-12 in the Treatment of Narcolepsy, poster number 0739. Further information will be made available on Axsome's website post-presentation.
Axsome Therapeutics (NASDAQ: AXSM) announced notable progress in its late-stage CNS pipeline, including two NDA submissions for AXS-05 in major depressive disorder (MDD) and AXS-07 in migraine expected by 4Q 2020. The company completed enrollment in Phase 3 trials for both drugs and has three FDA Breakthrough Therapy designations. Financially, Axsome reported a net loss of $18.3 million for Q2 2020, with R&D expenses of $10.5 million. As of June 30, 2020, the company had $190.7 million in cash, sufficient to support operations for at least two years.
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