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Axsome Initiates Phase III Study on Depression Candidate

Axsome Therapeutics, Inc. AXSM enrolled the first patient in its GEMINI (Glutamatergic and Monoaminergic Modulation in Depression) study, a phase III, randomized, double-blind, placebo-controlled trial of AXS-05 in the treatment of major depressive disorder (MDD). AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.

Shares of the company have soared 732.3% in the past year compared with the industry’s growth of 4.6%.


AXS-05 is a novel, oral, investigational non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity under development for the treatment of central nervous system (CNS) disorder.  The company is conducting a phase III STRIDE-1 study of AXS-05 in treatment resistant depression (TRD), and a phase II/III ADVANCE-1  study in agitation associated with Alzheimer's disease (AD). The company completed a phase II ASCEND study in MDD, and a phase II study  in smoking cessation.

If successfully developed, AXS-05 will be the first orally administered NMDA receptor antagonist approved for the treatment of MDD. According to the company, the results of either the GEMINI study in MDD or the ongoing STRIDE-1 study, if positive, would, in combination with its previously completed ASCEND study, be sufficient to support the filing of an NDA for AXS-05 for the treatment of MDD. 

The company expects top-line results from both the STRIDE-1 and GEMINI studies in the second half of 2019.

In March 2019, Axsome received Breakthrough Therapy designation from the FDA for AXS-05 for the treatment of MDD. The candidate has also been granted Fast Track designation by the FDA for the treatment of TRD and agitation associated with Alzheimer’s disease.

MDD affects about 7.1% of adults in the United States and is a chronic, mental  disorder that can result in suicide. 

The depression market is quite large and has many players, including biggies like Allergan AGN with product Viibryd, and Eli Lilly LLY with Cymbalta and Zyprexa.

In March 2019, the FDA approved Johnson & Johnson’s JNJ nasal spray, Spravato (esketamine), for treatment-resistant depression (TRD) in adults, but with a boxed warning. The nasal spray has been approved for use in conjunction with an oral antidepressant in patients with MDD, who have not benefited from multiple standard treatments.


Zacks Rank

Axsome currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank stocks here.

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