FDA gives Axsome speedy review for depression drug, while other indications wait in the wings
Two years after mid-stage results first sent their stock flying, Axsome announced the FDA has accepted their application for a new depression drug and promised to give it a hastened look.
The agency has given priority review to Axsome’s lead drug, AXS-05, for the treatment of major depressive disorder. The agency said they will give a decision on what would be Axsome’s first approved drug by Aug. 22, the company announced.
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