Axsome Therapeutics

221 articles about Axsome Therapeutics

• Axsome Therapeutics to Report Third Quarter 2020 Financial Results on November 5, 2020

  10/28/2020

  Axsome to host conference call and webcast on Thursday, November 5, 2020 at 8:00 AM Eastern Time

• Axsome Therapeutics Announces $225 Million Term Loan Facility with Hercules Capital

  9/29/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, has secured a $225 million term loan facility with Hercules Capital, Inc.

• Axsome Therapeutics Presents New Data from MOMENTUM Phase 3 Trial with AXS-07 Demonstrating Rapid Onset of Action and Reduced Symptom Recurrence in the Acute Treatment of Migraine

  9/24/2020

  Axsome Therapeutics, Inc. announced that AXS-07, the Company’s novel, oral, multi-mechanistic investigational medicine for the acute treatment of migraine, rapidly relieved and substantially reduced relapse of migraine pain, as compared to the potent active comparator rizatriptan, in the MOMENTUM Phase 3 trial.

• Axsome Therapeutics Announces Expedited Development of AXS-12 for the Treatment of Narcolepsy Based on FDA Breakthrough Therapy Meeting

  9/21/2020

  Single Phase 3 trial to be conducted to support an NDA filing of AXS-12 in the treatment of narcolepsy; trial initiation anticipated 1Q 2021

• Axsome Therapeutics Announces AXS-07 Phase 3 Migraine Trial Results Selected by the American Academy of Neurology Science Committee as Featured Presentation

  9/17/2020

  Data from MOMENTUM Phase 3 trial to be presented at the 2020 AAN Science Highlights Platform

• Axsome Therapeutics Presents New Data from GEMINI Phase 3 Trial with AXS-05 Demonstrating Rapid and Significant Improvements in Patient-Reported Outcomes in Major Depressive Disorder

  9/14/2020

  Rapid, durable, and statistically significant improvement demonstrated in patient-reported depressive symptoms, as measured by the QIDS-SR-16 total score compared to placebo (p=0.001)

• Axsome Therapeutics to Present New Data for AXS-05 in Major Depressive Disorder at the 33rd European College of Neuropsychopharmacology Congress

  9/10/2020

  Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that it will present clinical data on AXS-05 in the treatment of major depressive disorder (MDD) at the 33 rd Congress of the European College of Neuropsychopharmacology (ECNP), to be held virtually, September 12-15. AXS-05 (dextromethorphan/bupropion modulated delivery tablet

• Axsome Therapeutics to Present at the Morgan Stanley 18th Annual Global Healthcare Conference

  9/8/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that Herriot Tabuteau, MD, Axsome’s Chief Executive Officer, will participate in a virtual fireside chat at the Morgan Stanley 18th Annual Global Healthcare Conference on Thursday, September 17, 2020 at 10:15 AM Eastern Time.

• Axsome Therapeutics to Present at Upcoming Investor Conferences - Sep 03, 2020

  9/3/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, will participate in two upcoming investor conferences:

• Axsome Therapeutics Confirms Pivotal Status and Advancement of AXS-05 for the Treatment of Alzheimer’s Disease Agitation Based on Successful FDA Breakthrough Therapy Meeting

  8/31/2020

  Previously completed positive, pivotal ADVANCE-1 trial sufficient with single additional Phase 3 efficacy trial for NDA in Alzheimer’s disease agitation Initiation of Phase 3, placebo-controlled, randomized-withdrawal efficacy trial on track for 4Q 2020 Initiation of long-term safety trial in patients with Alzheimer’s disease agitation expected in 4Q 2020 No treatments are currently approved for the treatment of Alzheimer’s disease agitation

• Axsome Therapeutics to Present Data from the CONCERT Phase 2 Trial of AXS-12 in Narcolepsy at the SLEEP 2020 Annual Meeting

  8/28/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that it will present efficacy and safety data from the CONCERT Phase 2 trial of AXS-12 in the treatment of narcolepsy at the 34th Annual SLEEP Meeting of the Associated Professional Sleep Societies.

• Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-07 for the Acute Treatment of Migraine

  8/20/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that it has completed a successful pre-New Drug Application meeting with the U.S. Food and Drug Administration for AXS-07 for the acute treatment of migraine.

• Axsome Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update

  8/10/2020

  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, 2020.

• Axsome Therapeutics Announces Further Progress in AXS-05 Depression Clinical Program

  8/10/2020

  Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announces continued progress toward NDA filing of AXS-05 in the treatment of major depressive disorder (MDD)

• Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-12 for the Treatment of Narcolepsy

  8/5/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for AXS-12 for the treatment of cataplexy in patients with narcolepsy.

• Axsome Therapeutics to Report Second Quarter 2020 Financial Results on August 10, 2020

  7/30/2020

  Axsome to host conference call and webcast on Monday, August 10, 2020 at 8:00 AM Eastern Time

• Axsome Therapeutics Completes Successful FDA Pre-NDA Meeting for AXS-05 for the Treatment of Major Depressive Disorder

  7/13/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that it has completed a successful pre-New Drug Application meeting with the U.S. Food and Drug Administration for AXS-05 for the treatment of major depressive disorder.

• Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Alzheimer’s Disease Agitation

  6/26/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation for AXS-05 for the treatment of Alzheimer’s disease agitation.

• Axsome Therapeutics to Present at Upcoming Investor Conferences in June 2020

  6/4/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, will participate in two upcoming investor conferences

• Axsome Therapeutics Presents Data from GEMINI Phase 3 Trial of AXS-05 in Major Depressive Disorder at the 2020 American Society for Clinical Psychopharmacology Annual Meeting

  5/29/2020

  Axsome Therapeutics, Inc., a biopharmaceutical company developing novel therapies for the management of central nervous system disorders, announced that data from the GEMINI Phase 3 trial of AXS-05 in major depressive disorder will be presented in oral and poster sessions at the 2020 Annual Meeting of the American Society for Clinical Psychopharmacology, to be held virtually, May 29-30.