Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other Events
Item 8.01. Other Events.
On March27, 2019, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing that it had received, from the U.S. Food and Drug Administration, Breakthrough Therapy Designation for one of the Company’s product candidates, AXS-05, for the treatment of major depressive disorder.
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 |
Description |
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99.1 |
Press release dated March27, 2019. |
Axsome Therapeutics, Inc. Exhibit
EX-99.1 2 a19-7304_1ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Receives FDA Breakthrough Therapy Designation for AXS-05 for the Treatment of Major Depressive Disorder Designation offers potential for expedited development and review 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).
