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axsome Axsome Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update August 9 , 2021 Company to host conference call today at 8:00 AM Eastern NEW YORK , Aug. 09 , 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 second quarter ended June 30 , 2021 . " As part of the ongoing review of our NDA for AXS - 05 , the FDA recently notified us that they have identified deficiencies that preclude labeling discussions at this time . We are attempting to learn the nature of these deficiencies with the goal of addressing them , however , this development may lead to a delay in the potential approval of AXS - 05 . We will keep you informed as we learn more , " said Herriot Tabuteau , MD , Chief Executive Officer of Axsome . " Our other programs continue to advance . We successfully filed our NDA for AXS - 07 for the acute treatment of migraine in the second quarter , and we remain on track to initiate the planned Phase 3 trial of AXS - 12 for the treatment of narcolepsy this quarter . The buildout of our team and infrastructure is also continuing as we work towards our goal of delivering potentially life - changing medicines to people living with serious CNS 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 and is currently under review by the FDA . On July 30 , 2021 , the Company received a letter from the FDA stating that it has identified deficiencies that preclude discussion of labeling and post - marketing requirements / commitments at this time . The letter stated further that the notification does not reflect a final decision on the information under review . The letter did not state what the deficiencies are . In response to the Company's inquiries regarding the nature of the deficiencies since receipt of the letter , the FDA has informed the Company that their review is ongoing , but have not yet communicated any details regarding the nature of the deficiencies . The Prescription Drug User Fee Act ( PDUFA ) target action date for the NDA is August 22 , 2021 . Axsome has completed the MERIT trial , a Phase 2 , randomized , double - blind , placebo - controlled , relapse prevention trial of AXS - 05 in treatment resistant depression ( TRD ) patients . In a separate release issued this morning , Axsome announced that AXS - 05 met the primary and key secondary endpoint in the trial . AXS - 05 substantially and significantly delayed the time to relapse of depression ( p = 0.002 , primary endpoint ) , and prevented relapse of depression ( p = 0.004 , key secondary endpoint ) , compared to placebo . • AD 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 . Axsome anticipates completion of the trial in the fourth quarter of 2022 . • Smoking Cessation : Axsome is scheduled to meet with the FDA in the third quarter 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