Shares of Axsome Therapeutics are soaring after the company announced that AXS-05, its oral NMDA receptor antagonist met the primary endpoint and improved symptoms of depression in the GEMINI Phase 3 trial in major depressive disorder. AXS-05 met the primary endpoint by demonstrating a statistically significant reduction in the Montgomery-Asberg Depression Rating Scale total score compared to placebo at week six, with mean reductions from baseline of 16.6 points for AXS-05 and 11.9 points for placebo. Rates of remission from depression were statistically significantly greater for AXS-05 compared to placebo at week two and at every time point thereafter, being achieved by 39.5% of AXS-05 patients compared to 17.3% of placebo patients at week six, Axsome added. The company believes the positive results of the GEMINI trial, along with the previously completed ASCEND trial of AXS-05 in major depressive disorder, are sufficient to support submission of a New Drug Application for AXS-05 for the treatment of MDD. Axsome plans to file the NDA in the second half of 2020. Shares of Axsome are up 83%, or $38.81, to $85.60 in premarket trading.
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