A Crucial Major Depressive Disorder Study Is About to Be Underway

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After Axsome Therapeutics Inc. (NASDAQ: AXSM) announced that it has completed patient enrollment in its Gemini study, a Phase 3 trial of AXS-05 in patients with major depressive disorder (MDD), shares of the firm saw a handy gain on Wednesday.

Approximately 300 patients with a confirmed diagnosis of moderate to severe MDD will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for six weeks. Assessments including the Montgomery-Åsberg Depression Rating Scale, safety parameters, clinician-rated scales, as well as patient-reported outcome measures, will be conducted throughout the study.

Note that MDD is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy and other emotional and physical symptoms, and it impairs social, occupational, educational or other important functioning. In severe cases, MDD can result in suicide.

According to the National Institutes of Health, an estimated 7.1% of U.S. adults, or approximately 17.3 million, experience MDD each year. Nearly two-thirds of diagnosed and treated patients do not experience adequate treatment response with currently available first-line therapy, highlighting the need for additional therapies with new mechanisms of action.

Axsome remains on track to report topline results from the Gemini study in the fourth quarter of 2019.

Shares of Axsome traded about 4% on Wednesday, at $21.43 in a 52-week range of $1.94 to $30.50. The consensus price target is $36.83.


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