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Tuesday, 05/28/2019 8:31:47 PM

Tuesday, May 28, 2019 8:31:47 PM

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>>> Axsome Therapeutics To Present Data From ASCEND Phase 2 Trial Of AXS-05 In Major Depressive Disorder At The 2019 American Society For Clinical Psychopharmacology Annual Meeting

http://www.globenewswire.com/news-release/2019/05/21/1833251/0/en/Axsome-Therapeutics-To-Present-Data-From-ASCEND-Phase-2-Trial-Of-AXS-05-In-Major-Depressive-Disorder-At-The-2019-American-Society-For-Clinical-Psychopharmacology-Annual-Meeting.html

May 21, 2019 07:00 ET | Source: Axsome Therapeutics, Inc.
NEW YORK, May 21, 2019 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that data from the Phase 2 ASCEND trial of AXS-05 in major depressive disorder (MDD) will be presented in oral and poster sessions at the 2019 Annual Meeting of the American Society for Clinical Psychopharmacology (ASCP), to be held in Scottsdale, Arizona, May 28-31. Axsome will also give today a poster presentation on the clinical development of AXS-05 in neuropsychiatric disorders at the 2019 American Psychiatric Association (APA) Annual Meeting in San Francisco, California. AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

Below are the details of the presentations:

American Society for Clinical Psychopharmacology (ASCP) Annual Meeting:

Oral Presentation
Title: AXS-05, Oral NMDA Receptor Antagonist with Multimodal Activity, in Major Depressive Disorder: Results of a Phase 2, Double-Blind, Active-Controlled Trial
Date: Tuesday, May 28, 2019
Time: 2:54 PM – 3:05 PM Mountain Time

Poster Presentation
Title: Efficacy and Safety of AXS-05, an Oral NMDA Receptor Antagonist with Multimodal Activity, in Major Depressive Disorder: Results of a Phase 2, Double-Blind, Active-Controlled Trial
Poster Number: W43
Date: Wednesday, May 29, 2019
Time: 11:15 AM – 1:00 PM Mountain Time

American Psychiatric Association (APA) Annual Meeting:

Poster Presentation
Title: AXS-05: A Mechanistically Novel Oral Therapeutic in Development for Neuropsychiatric Disorders
Poster Number: P7-141
Date: Tuesday, May 21, 2019
Time: 10:00 AM – 12:00 PM Pacific Time

A copy of the posters will be available shortly after the meetings on Axsome’s website at www.axsome.com.

About AXS-05

AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity under development for the treatment of major depressive disorder and other central nervous system (CNS) disorders. AXS-05 consists of dextromethorphan and bupropion and utilizes Axsome’s metabolic inhibition technology. The dextromethorphan component of AXS-05 is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist, also known as a glutamate receptor modulator, which is a novel mechanism of action, meaning it works differently than currently available therapies for depression. The dextromethorphan component of AXS-05 is also a sigma-1 receptor agonist, nicotinic acetylcholine receptor antagonist, and inhibitor of the serotonin and norepinephrine transporters. The bupropion component of AXS-05 serves to increase the bioavailability of dextromethorphan, and is a norepinephrine and dopamine reuptake inhibitor, and a nicotinic acetylcholine receptor antagonist. AXS-05 is covered by more than 30 issued U.S. and international patents which provide protection out to 2034. AXS-05 is not approved by the FDA.

About Axsome Therapeutics, Inc.

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders for which there are limited treatment options. Axsome’s core CNS product candidate portfolio includes four clinical-stage candidates, AXS-05, AXS-07, AXS-09, and AXS-12. AXS-05 is currently in a Phase 3 trial in treatment resistant depression (TRD), and a Phase 2/3 trial in agitation associated with Alzheimer’s disease (AD). AXS-05 is also being developed for major depressive disorder (MDD) and smoking cessation treatment. AXS-07 is currently in a Phase 3 trial for the acute treatment of migraine. AXS-12 is currently in a Phase 2 trial in narcolepsy. The Axsome Pain and Primary Care business unit (Axsome PPC) houses Axsome’s pain and primary care assets, including AXS-02 and AXS-06, and intellectual property which covers these and related product candidates and molecules being developed by Axsome and others. AXS-02 is being developed for osteoporosis, the pain of knee osteoarthritis, and chronic low back pain. AXS-06 is being developed for osteoarthritis and rheumatoid arthritis. AXS-02, AXS-05, AXS-06, AXS-07, AXS-09, and AXS-12 are investigational drug products not approved by the FDA. For more information, please visit the Company’s website at axsome.com. The Company may occasionally disseminate material, nonpublic information on the company website.

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