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axsome Axsome Therapeutics Reports Third Quarter 2021 Financial Results and Provides Business Update November 8 , 2021 Company to host conference call today at 8:00 AM Eastern NEW YORK , Nov. 08 , 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 third quarter ended September 30 , 2021 . " Over the past several months we have continued to advance our differentiated late - stage CNS product candidates aimed at meaningfully improving the lives of patients . FDA review of our NDA for AXS - 05 in depression continues , and the NDA for AXS - 07 in migraine was accepted , positioning Axsome to potentially commercialize two new treatments in the near to intermediate term for patients living with these serious CNS disorders , " said Herriot Tabuteau , MD , Chief Executive Officer of Axsome . " Our commercial launch preparations are essentially complete and we remain focused on ensuring timely and successful launches , assuming approvals . The rest of our rich pipeline continues to progress , highlighted by our ongoing Phase 3 ACCORD trial of AXS - 05 in Alzheimer's disease agitation , the recent initiation of our Phase 3 SYMPHONY trial of AXS - 12 in narcolepsy , and the ongoing manufacturing work to support the planned NDA filing of AXS - 14 for fibromyalgia . In addition , based on FDA Pre - IND meeting guidance , we plan to proceed to a Phase 2/3 trial of AXS - 05 in smoking cessation and expect to provide timing on initiation of that trial next year . " Business Update Axsome is committed to developing products that meaningfully improve the lives of patients . 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 and is currently under review by the FDA . On August 20 , 2021 , the FDA informed the Company in a teleconference that its review of the NDA would not be completed by the Prescription Drug User Fee Act ( PDUFA ) target action date of August 22 , 2021. The Company was recently informed of two deficiencies related to analytical methods in the Chemistry , Manufacturing , and Controls ( CMC ) section of the NDA , which must be addressed prior to the FDA taking action on the NDA . The Company believes these deficiencies are addressable and is confirming the details of the request with the FDA . • Alzheimer's Disease Agitation : Axsome is conducting 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 . Based on current enrollment trends , Axsome now anticipates completion of the trial in the first half of 2023 . • Smoking Cessation : Axsome has received from the FDA positive Pre - Investigational New Drug Application ( Pre - IND ) meeting written guidance from the FDA on a proposed clinical developmental plan for dextromethorphan - bupropion as an aid to smoking cessation . Based on this feedback , Axsome plans to proceed to a pivotal Phase 2/3 trial in this indication . The Company intends to provide information on the timing of initiation of this study in 2022 . 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's NDA for AXS - 07 for the acute treatment of migraine was accepted for review by the FDA . The FDA has set a PDUFA target action date for the NDA of April 30 , 2022. The FDA notified the Company that , due to COVID - 19 pandemic - related travel restrictions , they may be unable to complete a required inspection of a contract manufacturing facility , located in the United States , prior to the PDUFA date , and that they will continue to monitor the public health