Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other Events
Item 8.01. Other Events.
On January7, 2019, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing that AXS-05 met the prespecified primary endpoint and significantly improved symptoms of depression in the Company’s ASCEND Phase 2 trial in major depressive disorder (“MDD”). The Company will host a conference call at 8:30 a.m.ET on January7, 2019 to discuss the topline results of the ASCEND trial of AXS-05 in MDD.
The full text of the press release is filed as Exhibit99.1 hereto and is incorporated herein by reference. A copy of the presentation that the Company will use in connection with the conference call is filed as Exhibit99.2 hereto and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
Axsome Therapeutics, Inc. Exhibit
EX-99.1 2 a19-1343_1ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces AXS-05 Achieves Primary Endpoint in Phase 2 Trial in Major Depressive Disorder Demonstrated statistically significant improvement in MADRS scores compared to active comparator (p<0.001 on primary endpoint) Rapid improvement in depressive symptoms demonstrating statistically significant superiority over active comparator within the first week (p=0.045 on CGI-I) Improvement with AXS-05 versus active comparator seen on multiple secondary endpoints,…
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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).