Axsome Therapeutics (AXSM) announced the FDA has approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer's disease. The FDA approval of AUVELITY is supported by a clinical program which included the Phase 3 ADVANCE-1 and ACCORD-2 studies.
AUVELITY is a first-in-class treatment for Alzheimer's disease agitation which targets the N-methyl D-aspartate and sigma-1 receptors. It was developed with FDA Breakthrough Therapy designation and evaluated by the FDA under Priority Review. AUVELITY is also FDA-approved for the treatment of major depressive disorder in adults.
At last close on NasdaqGM, Axsome shares were trading at $207.75, up 12.94%.
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