Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other EventsItem 8.01.Other Events.
On July25, 2017, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-06, a novel, oral, non-opioid, fixed-dose combination of meloxicam and esomeprazole being developed for the treatment of osteoarthritis and rheumatoid arthritis. The Company also announced that it had received, from the U.S. Food and Drug Administration, Pre-Investigational New Drug Application written guidance on a proposed clinical developmental plan for AXS-06.
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.
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Exhibit Number
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Description
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99.1
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Press release dated July25, 2017.
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Axsome Therapeutics, Inc. ExhibitEX-99.1 2 a17-18419_1ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces AXS-06 (MoSEIC Meloxicam and Esomeprazole) Meets PrimaryEndpoint in Phase 1 Clinical Trial AXS-06 is an oral,…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). Axsome Therapeutics,Inc. (NASDAQ:AXSM) Recent Trading Information
Axsome Therapeutics,Inc. (NASDAQ:AXSM) closed its last trading session up +0.45 at 6.15 with 92,055 shares trading hands.