Axsome Therapeutics,Inc. (NASDAQ:AXSM) Files An 8-K Other EventsItem 8.01.Other Events.
On November28, 2017, Axsome Therapeutics,Inc. (the “Company”) issued a press release announcing its next product candidate, AXS-07, which is being developed for the acute treatment of migraine. AXS-07 is an oral, fixed-dose combination of MoSEIC™ meloxicam and rizatriptan.
The Company has received Pre-Investigational New Drug Application written guidance from the U.S. Food and Drug Administration on a proposed clinical developmental plan for AXS-07, including a planned Phase 3 trial. Based on this feedback, the Company believes that only one Phase 3 trial may be needed for the approval of AXS-07 for the treatment of migraine. The Company anticipates starting this trial in 2018, contingent on the availability of resources. The U.S. Patent and Trademark Office recently issued patent number 9,821,075 which covers MoSEIC meloxicam and provides protection for AXS-07 into 2036.
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 November28, 2017.
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Axsome Therapeutics, Inc. ExhibitEX-99.1 2 a17-27615_1ex99d1.htm EX-99.1 Exhibit 99.1 Axsome Therapeutics Announces AXS-07 for the Treatment of Migraine Incorporates new molecular entity for migraine and Axsomes MoSEIC technology Potential for superior efficacy as compared to current treatments FDA Pre-IND meeting written guidance received Issued U.S. patent provides protection into 2036 Phase 3 trial anticipated in 2018 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).