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Axsome Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Update
Company to host conference call today at 8:00 AM Eastern NEW YORK, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a
About this update from Axsome Therapeutics, Inc.
[{"type":"text","content":"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 de...