Axsome Therapeut - AXSM STOCK NEWS

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.