Business
Axsome Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update
NDA filing for Breakthrough Therapy designated AXS-05 in MDD expected in 4Q 2020 NDA filing for AXS-07 in migraine expected in 4Q 2020 Topline results for
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"NDA filing for Breakthrough Therapy designated AXS-05 in MDD expected in 4Q 2020\n NDA filing for AXS-07 in migraine expected in 4Q 2020 Topline results for STRIDE-1 Phase 3 trial of AXS-05 in TRD on track for 1Q 2020 Topline results for INTERCEPT Phase 3 trial of AXS-07 in treatment of migraine on track for 1Q 2020 Topline results for ADVANCE Phase 2/3 trial of AXS-05 in Alzheimer’s disease agitation anticipated in 3Q 2020 Initiation of Phase 3 trial of AXS-12 in narcolepsy anticipated in 2020 Company to host conference call today at 8:00 AM Eastern NEW YORK, March 12, 2020 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today reported financial results for the fourth quarter and year ended December 31, 2019. “Axsome delivered on several transformative achievements in 2019, including positive NDA-enabling clinical trial readouts for AXS-05 in depression and for AXS-07 in migraine, propelling Axsome potentially towards commercial stage as early as 2021,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “In addition, our AXS-12 product candidate for narcolepsy achieved positive Phase 2 results and is progressing to Phase 3, and through our agreement with Pfizer earlier this year, we expanded our Phase 3 pipeline with the addition of AXS-14 for the treatment of fibromyalgia.” Dr. Tabuteau said, “We expect continued operational momentum in 2020 with the anticipated filing of the two NDAs for AXS-05 in depression and for AXS-07 in migraine, which we expect to occur in the fourth quarter. Furthermore, we are on track for readouts from our STRIDE-1 Phase 3 trial of AXS-05 in treatment resistant depression and our INTERCEPT Phase 3 trial of AXS-07 in early treatment of migraine, both by the end of this month. We expect readouts from our ADVANCE-1 Phase 2/3 trial of AXS-05 in Alzheimer’s disease agitation in the third quarter. By providing new mechanisms of action, and potentially faster, greater and broader efficacy as compared to currently available treatments, our investigational medicines have the potential to change the current standard of care for difficult-to-treat CNS disorders and transform the lives of patients living with these conditions.” CNS Pipeline Update Axsome is...