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 September7, 2017, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing that the interim efficacy analysis of the Phase 3 CREATE-1 trial of AXS-02 in complex regional pain syndrome is expected year-end 2017. The interim analysis for CREATE-1 will be performed by an independent data monitoring committee (the “IDMC”) and results of the analysis are expected late December2017 to early January2018.

The IDMC will also perform the planned interim analysis of the Phase 3 COAST-1 trial of AXS-02 in knee osteoarthritis associated with bone marrow lesions. Because of member availability, and for efficiency, the IDMC will analyze both CREATE-1 and COAST-1 trials at the same committee meeting. Therefore interim analysis results for COAST-1 are now also expected late December2017 to early January2018, instead of the third quarter of 2017, as previously anticipated.

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 September7, 2017.


Axsome Therapeutics, Inc. Exhibit
EX-99.1 2 a17-21878_1ex99d1.htm EX-99.1 Exhibit 99.1     Axsome Announces CREATE-1 Interim Analysis Expected Year-End 2017   Interim analysis results for both CREATE-1 and COAST-1 trials anticipated late December to early January   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).