Business
Axsome Therapeutics Reports Third Quarter 2020 Financial Results and Provides Business Update
COMET Phase 3 long-term safety trial of AXS-05 in MDD, and MOVEMENT Phase 3 long-term safety trial of AXS-07 in migraine completed NDA submissions for AXS-05
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"COMET Phase 3 long-term safety trial of AXS-05 in MDD, and MOVEMENT Phase 3 long-term safety trial of AXS-07 in migraine completed\n NDA submissions for AXS-05 in depression expected in January 2021, and for AXS-07 in migraine expected in 1Q 2021 Launch readiness activities progressing with buildout of Digital-Centric Commercialization (DCC™) platform Efficacy results from three Phase 2 open-label efficacy trials of AXS-05 in TRD, antidepressant unresponsive MDD, and suicidal ideation, on track for 4Q 2020 Efficacy results from MOVEMENT Phase 3 open-label trial of AXS-07 in migraine expected in 4Q 2020 Phase 3 trial of AXS-05 in Alzheimer’s disease agitation on track for initiation in 4Q 2020 Phase 3 trial of AXS-12 in narcolepsy on track for initiation in 1Q 2021 FDA meeting for AXS-14 in fibromyalgia scheduled for 1Q 2021 Company to host conference call with slides today at 8:00 AM Eastern NEW YORK, Nov. 05, 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 third quarter ended September 30, 2020. “Over the past several months, we continued to advance our AXS-05 and AXS-07 product candidates towards NDA submissions in major depressive disorder and migraine, and intensified our commercial launch readiness activities,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome. “We also advanced the rest of our late-stage pipeline holding two positive FDA Breakthrough Therapy designation meetings, one for AXS-05 in Alzheimer’s disease agitation, and one for AXS-12 in narcolepsy, resulting in expedited development paths for both programs. Non-dilutive committed capital from our new term loan facility combined with our cash provide financial resources approaching $400 million, positioning us well for our two potential product launches starting next year. Our intellectual property portfolio continues to grow with recently issued and allowed patents for AXS-05 in depression which now provide protection out to 2040. We anticipate an active next few months as we complete our NDA submissions for AXS-05 and AXS-07, release topline efficacy data from open-label trials with these product candidates, initiate Phase 3 trials for AXS-05 in Alzheimer’s disease agitation...