Axsome Therapeutics, Inc - AXSM STOCK NEWS

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.

Axsome Therapeutics (NASDAQ: AXSM) will report its Q2 2020 financial results on August 10, 2020, prior to the U.S. market opening. A management conference call will follow at 8:00 AM ET to discuss the results and provide a business update. The company is focused on developing therapies for central nervous system disorders, with five product candidates including AXS-05 for major depressive disorder and AXS-07 for migraine treatment. All candidates are investigational drugs and not FDA-approved.

Axsome Therapeutics announced a successful pre-NDA meeting with the FDA for AXS-05, aimed at treating major depressive disorder (MDD). The company is on track for NDA submission in Q4 2020, supported by positive trial results from GEMINI and ASCEND, demonstrating significant reductions in depressive symptoms. AXS-05, a novel NMDA receptor antagonist, received Breakthrough Therapy Designation, potentially allowing Priority Review. If approved, it could be the first oral NMDA receptor antagonist for depression, addressing a critical need in MDD treatment.

Axsome Therapeutics, Inc. (NASDAQ: AXSM) will participate in two investor conferences: the William Blair 40th Annual Growth Stock Conference on June 9, 2020, at 1:20 PM CT, and the SVB Leerink CybeRx Series: 2nd Annual CNS Forum on June 23, 2020, at 2:45 PM ET. Both events will feature virtual fireside chats with CEO Herriot Tabuteau. Interested parties can access the live webcast of the William Blair event on the company’s website. Axsome focuses on developing novel therapies for central nervous system disorders, with a portfolio that includes multiple clinical-stage candidates.