Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other EventsItem 8.01.Other Events.
On January9, 2018, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing the conduct, by an independent data monitoring committee, of interim analyses of the Phase 3 CREATE-1 trial of AXS-02 in complex regional pain syndrome and of the Phase 3 COAST-1 trial of AXS-02 in knee osteoarthritis associated with bone marrow lesions, 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.
On January9, 2018, Herriot Tabuteau, M.D., the Company’s Chief Executive Officer, will present at the 10th Annual Biotech Showcase to provide an overview of the Company’s business and late-stage clinical product candidates. The materials to be used in connection with this presentation are filed as Exhibit99.2 hereto and are incorporated herein by reference.
Item 8.01.Financial Statements and Exhibits.
Axsome Therapeutics, Inc. ExhibitEX-99.1 2 a18-2496_1ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces AXS-02 Independent Data Monitoring Committee Recommends Continuation of COAST-1 Trial and Discontinuation of CREATE-1 Trial COAST-1 is a Phase 3 trial of AXS-02 in knee osteoarthritis associated with bone marrow lesions CREATE-1 is a Phase 3 trial of AXS-02 in complex regional pain syndrome Significant reduction in bone resorption confirms potent pharmacologic activity Company to host conference call today at 8:00 AM Eastern 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).