AXSM - Axsome says it remains on track to submit AXS-05 marketing application to the FDA

Axsome Therapeutics ([[AXSM]] +0.1%) announces that it remains on track and is in the process of submitting a New Drug Application for AXS-05 in major depressive disorder to the U.S. FDA.Axsome initiated its ACCORD study, a Phase 3, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AXS-05 in the treatment of Alzheimer’s disease agitation, in December last year.AXS-05 is a novel, oral, investigational NMDA receptor antagonist with multimodal activity.The company had also announced positive results from the open-label Phase 2 COMET-SI trial of AXS-05 in patients with major depressive disorder who have suicidal ideation, last month.

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Axsome says it remains on track to submit AXS-05 marketing application to the FDA