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Axsome: FDA Approves AUVELITY For Treatment Of Agitation Associated With Dementia Due To Alzheimer's

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

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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Global Economics Weekly Update - April 27 – May 01, 2026

May 01, 2026 15:54 ET
Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.

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