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axsome Axsome Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update May 10 , 2021 Company to host conference call today at 8:00 AM Eastern NEW YORK , May 10 , 2021 ( 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 , 2021 . " We continued to make significant strides in the quarter toward becoming a premier biopharmaceutical company focused on delivering potentially life - changing medicines to people living with serious CNS conditions . We successfully filed our NDA for AXS - 05 for the treatment of MDD with the FDA , which was granted Priority Review , and are on track to file our NDA for AXS - 07 for the acute treatment of migraine this quarter , " said Herriot Tabuteau , MD , Chief Executive Officer of Axsome . “ Pre - commercial activities are intensifying as planned to ensure launch readiness assuming FDA approval . The rest of our pipeline continues to progress with the anticipated initiation of the planned Phase 3 trial for AXS - 12 for the treatment of narcolepsy mid - year . " " Axsome is proud to observe May is Mental Health Month and is partnering with advocacy groups to help raise awareness and support for people living with depression and other mental health conditions , " continued Dr. Tabuteau . " Recent data from the Centers for Disease Control indicate a more than four - fold increase in the prevalence of depression symptoms in U.S. adults compared to prior to the pandemic . The need for effective mental health treatments therefore has never been greater , and Axsome is committed to developing innovative treatments for those living with the debilitating effects of depression and other mental health conditions . " Business Update For the many people facing unsatisfactory treatments for CNS disorders , Axsome accelerates the invention and adoption of life - changing medicines . The Company is developing a portfolio of differentiated , patent - protected , CNS product candidates with four in active clinical development . AXS - 05 AXS - 05 ( dextromethorphan - bupropion ) is Axsome's novel , oral , investigational NMDA receptor antagonist with multimodal activity being developed for the following indications : major depressive disorder ( MDD ) , Alzheimer's disease ( AD ) agitation , and smoking cessation . AXS - 05 has been granted U.S. Food and Drug Administration ( FDA ) Breakthrough Therapy designations for MDD , and for AD agitation . • Depression : Axsome's New Drug Application ( NDA ) for AXS - 05 for the treatment of MDD was granted Priority Review by the FDA . The FDA has set a Prescription Drug User Fee Act ( PDUFA ) target action date for the NDA of August 22 , 2021 . • AD Agitation : Axsome initiated the ACCORD study , a Phase 3 , double - blind , placebo - controlled , multicenter , randomized withdrawal trial to evaluate the efficacy and safety of AXS - 05 in the treatment of Alzheimer's disease ( AD ) agitation , in December 2020. Enrollment in the trial is progressing . • Smoking Cessation : Axsome is scheduled to meet with the FDA in the third quarter of 2021 to discuss the continued clinical development of AXS - 05 as an aid to smoking cessation treatment . Axsome previously announced positive results from a Phase 2 trial of AXS - 05 for smoking cessation treatment conducted under a research collaboration between Axsome and Duke University . AXS - 07 AXS - 07 ( MOSEICTM meloxicam - rizatriptan ) is Axsome's novel , oral , rapidly absorbed , multi - mechanistic , investigational medicine for the acute treatment of migraine . • Migraine : Axsome is compiling the NDA for AXS - 07 for the acute treatment of migraine , which is on track for submission to the FDA in the second quarter of 2021. Axsome plans to announce the FDA's decision regarding its acceptance of the NDA filing in the third quarter of 2021 . AXS - 12 AXS - 12 ( reboxetine ) is Axsome's novel , oral , potent , and highly selective norepinephrine reuptake inhibitor for the treatment of narcolepsy . AXS - 12 has been granted FDA Orphan Drug designation for the treatment of narcolepsy as well as Breakthrough Therapy designation for the treatment of