Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other EventsItem 8.01. Other Events.
On December10, 2018, Axsome Therapeutics,Inc. issued a press release announcing the conduct, by an independent data monitoring committee, of an interim analysis of the Phase 2/3 ADVANCE-1 trial of AXS-05 in agitation associated with Alzheimer’s disease, as well as the recommendations of the committee.
The full text of the press release is filed as Exhibit99.1 hereto and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d)Exhibits.
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Exhibit Number
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Description
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99.1
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Press release dated December10, 2018.
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Axsome Therapeutics, Inc. ExhibitEX-99.1 2 a18-41321_1ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces Positive Outcome of Interim Analysis of ADVANCE-1 Phase 2/3 Trial of AXS-05 in Alzheimers Disease Agitation IDMC recommends continuation of trial evaluating AXS-05 versus placebo in Alzheimers disease agitation IDMC recommends no further enrollment to single-agent bupropion arm NEW YORK,…To view the full exhibit click here
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).
