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Axsome Therapeutics Shares Open 82% Higher on Phase 3 MDD Trial Outcome

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Axsome Therapeutics shares reached a new 52-week high price today after the company reported that its AXS-05 drug achieved primary endpoint in the GEMINI Phase 3 trial in Major Depressive Disorder. The firm indicated that the positive results support a New Drug Application filing in H2/20.

Early this morning, clinical-stage biopharmaceutical company, Axsome Therapeutics Inc. (AXSM:NASDAQ), which focuses on developing novel therapies for the management of central nervous system (CNS) disorders, announced that "AXS-05, a novel, oral, investigational NMDA receptor antagonist with multimodal activity, met the primary endpoint and rapidly and significantly improved symptoms of depression in the GEMINI Phase 3 trial in major depressive disorder (MDD)."

The company advised that the GEMINI study was a double-blind study of AXS-05 (dextromethorphan/bupropion modulated delivery tablet) in 327 adult patients with confirmed moderate to severe MDD. The firm indicated that AXS-05 was well tolerated in the trial and met the primary endpoint by demonstrating a highly statistically significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score compared to placebo.

Professor Maurizio Fava, MD, psychiatrist-in-chief at Massachusetts General Hospital (MGH), director of the Division of Clinical Research of the MGH Research Institute, and associate dean for clinical & translational research at Harvard Medical School, commented, "AXS-05 demonstrated a rapid and very clinically meaningful improvement in depressive symptoms, observed after only one week, in this large and well-controlled Phase 3 trial in major depressive disorder. Given the known challenges of conducting trials in psychiatry, it is very encouraging to see replication of Phase 2 findings in such a robust way...Clinical depression is a potentially life-threatening condition. Currently marketed antidepressants fail to provide adequate treatment response in almost two thirds of treated patients, and may take up to six to eight weeks to provide clinically meaningful response. These data suggest that AXS-05, as an oral NMDA receptor antagonist with multimodal activity, may represent a novel treatment for major depressive disorder."

The company's CEO Herriot Tabuteau, MD, added, "We are very pleased with the compelling results of the GEMINI trial which demonstrate the potential for AXS-05 to provide significant benefits to patients living with depression, based on observed rapid and sustained antidepressant effects, resulting from its potentially first-in-class, oral NMDA receptor antagonist and multimodal mechanism of action...The progress of the AXS-05 clinical program in mood disorders reflects Axsome's commitment to accelerating innovation to address serious CNS disorders. With GEMINI and the previously completed ASCEND study, the efficacy of AXS-05 in major depressive disorder has now been demonstrated in two positive well-controlled trials, enabling the filing of an NDA for AXS-05, which is anticipated in the coming year."

The firm explained, "AXS-05 was granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of MDD in March 2019, and that based on the outcome of the FDA Breakthrough Therapy meeting, Axsome believes the positive results of the GEMINI and ASCEND trials of AXS-05 in MDD, are sufficient to support submission of a New Drug Application (NDA) for AXS-05 for the treatment of MDD in H2/20."

Cedric O'Gorman, MD, SVP of clinical development and medical affairs of Axsome, remarked, "Depression is a major public health concern with most patients failing to adequately respond to currently approved antidepressants...The positive results of the GEMINI study are significant and exciting because they bring us closer to our goal of addressing this public health need with a potentially first-in-class, rapid-acting, effective, oral, antidepressant which can be safely administered at home. With its modulation of glutamate neurotransmission, if approved, AXS-05 would represent the first mechanistically novel oral pharmacotherapy for depression in over 30 years."

Axsome stated that "major depressive disorder (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 which impairs social, occupational, educational, or other important functioning. In severe cases, MDD can result in suicide...Patients diagnosed with MDD are defined as having treatment resistant depression (TRD) if they have failed to respond to two or more antidepressant therapies."

Axsome Therapeutics is headquartered in New York. The firm states that its core CNS product candidate portfolio includes four clinical-stage candidates: AXS-05; AXS-07; AXS-09 and AXS-12. Ongoing studies include a phase 3 trial of AXS-05 in treatment resistant depression, a phase 3 trial in major depressive disorder, and a phase 2/3 trial in agitation associated with Alzheimer's disease. The company also has two active phase 3 trials of its AXS-07 for the acute treatment of migraine, and a phase 2 trial of AXS-12 in narcolepsy.

Axsome Therapeutics began the day with a market cap of about $1.6 billion with approximately 34.51 million shares outstanding and a short interest of 17.7%. AXSM shares opened much higher today at $85.2965 (+$38.51, +82.30%) compared to Friday's $46.79 closing price. The stock has traded between $72.85 and $88.00 per share today and presently is trading at $84.38 (+$37.60, +80.35%).

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