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) 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.
Summary not available.
Summary not available.