Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other Events

ME Staff 8-k
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Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other Events
Item 8.01.Other Events.

On July17, 2017, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing that it had enrolled the first patient in the Company’s Phase 2/3 ADVANCE-1 (Addressing Dementia Via Agitation-Centered Evaluation 1) Study, a Phase 2/3 trial evaluating the efficacy and safety of AXS-05 for the treatment of Alzheimer’s disease agitation.

The full text of the press release is filed as Exhibit99.1 hereto and is incorporated herein by reference.

Item 8.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number

Description

99.1

Press release dated July17, 2017.


Axsome Therapeutics, Inc. Exhibit
EX-99.1 2 a17-18049_1ex99d1.htm EX-99.1 Exhibit 99.1     Axsome Therapeutics Initiates Phase 2/3 Trial of AXS-05 for Alzheimer’s Disease Agitation   First patient enrolled in the ADVANCE-1 study   Agitation reported in nearly 50% of patients with Alzheimer’s disease   FDA Fast Track designation previously received for AXS-05 for Alzheimer’s disease agitation   Second indication for AXS-05 in late-stage clinical trials   NEW YORK,…
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About Axsome Therapeutics,Inc. (NASDAQ:AXSM)

Axsome Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing therapies for the management of central nervous system (CNS) disorders, including pain. It operates in the business of developing novel therapies for the management of CNS disorders segment. Its product candidate, AXS-02 (disodium zoledronate tetrahydrate), is an oral, targeted, non opioid therapeutic for chronic pain. It is developing AXS 02 for the treatment of pain in over three conditions, such as complex regional pain syndrome (CRPS); knee osteoarthritis (OA) associated with bone marrow lesions (BMLs), and chronic low back pain (CLBP), associated with type I, or mixed type I and type II Modic changes (MCs). Its product candidate, AXS 05, is a fixed dose combination of dextromethorphan (DM) and bupropion. It is developing AXS 05 for the treatment of over two conditions, such as treatment resistant depression (TRD), and agitation in patients with Alzheimer’s disease (AD).