Business
Axsome Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update
Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company Positive pivotal Phase 2/3 results for AXS-05 in Alzheimer’s disease
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"Clinical successes highlight Axsome’s accelerated evolution into a leading CNS company\n Positive pivotal Phase 2/3 results for AXS-05 in Alzheimer’s disease agitation further deepen innovative pipeline Positive efficacy results in 5 significant CNS indications with 4 candidates advance broad late-stage pipeline Two NDA submissions, for AXS-05 in MDD and AXS-07 in migraine, on track for 4Q 2020 Pre-commercialization activities underway for potentially first-in-class or best-in-class CNS therapies Company to host conference call today at 8:00 AM Eastern NEW YORK, May 08, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the first quarter ended March 31, 2020. “The recent clinical successes in our late-stage pipeline, including positive efficacy data in depression, Alzheimer’s disease agitation, migraine, narcolepsy, and fibromyalgia, highlight Axsome’s accelerated evolution into a leading, innovative CNS company,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “The ability to tackle unmet medical needs in these serious and difficult-to-treat CNS diseases, underscores the importance of our novel investigational medicines. As we move towards the submission of two NDAs in the fourth quarter, one for AXS-05 in depression and one for AXS-07 in migraine, our commercial team is focused on launch-readiness activities to ensure successful commercial execution. In parallel, we look to continue the momentum in our other late-stage development programs, including AXS-05 in Alzheimer’s disease agitation, for which we intend to meet with the FDA after the recently announced positive ADVANCE-1 pivotal trial results in this indication, and AXS-12 in narcolepsy, for which we remain on track to initiate Phase 3 trials later this year.” CNS Pipeline Update Axsome is developing a portfolio of differentiated, patent-protected, central nervous system (CNS) product candidates. For the many people facing unsatisfactory treatments for CNS disorders, Axsome accelerates the invention and adoption of life-changing medicines. The Company’s CNS pipeline includes four differentiated product candidates in active clinical development. AXS-05: AXS-05 (dextromethorphan/bupropion mo...