Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other Events
Item 8.01 Other Events
On February6, 2019, Axsome Therapeutics, Inc. (the “Company”) issued a press release announcingthat the Company reached an agreement with the U.S. Food and Drug Administration under a Special Protocol Assessment (SPA) for its MOMENTUM (Maximizing Outcomes in Treating Acute Migraine) Phase 3 trial of AXS-07 (MoSEIC™ meloxicam and rizatriptan) in migraine.
The full text of the press release is filed as Exhibit 99.1 hereto and incorporated herein by reference.
Item 8.01Financial Statements and Exhibits.
Press Release datedFebruary6, 2019.
Axsome Therapeutics, Inc. Exhibit
EX-99.1 2 ex-99d1.htm EX-99.1 axsm_99-1 AXS-07 SPA Exhibit 99.1 Axsome Therapeutics Receives FDA Agreement under Special Protocol Assessment (SPA) for the MOMENTUM Phase 3 Trial of AXS-07 in Migraine FDA agreement achieved on Phase 3 trial design,…
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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).