Axsome Therapeutics Rallies After Auvelity Gains FDA Approval

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Biopharmaceutical company Axsome Therapeutics (NASDAQ:AXSM) surged Friday after it announced that the U.S. Food and Drug Administration (FDA) has approved Auvelity for treating major depressive disorder (MDD) in adults.

Axsome shares hit a high of $61.11 following the news. They have since slipped slightly but are still up 34% at $56.84 per share.

According to the company, Auvelity is the first and only rapid-acting oral medicine approved for the treatment of MDD.

The drug was studied in a clinical program that included more than 1,100 patients with depression. It was shown to be statistically significantly superior to placebo in improving depressive symptoms.

Back in March 2019, the FDA granted Breakthrough Therapy designation for Auvelity for the treatment of MDD.

“We are thrilled to contribute to potentially fundamental advances in neuropsychiatry by providing clinicians the first rapid-acting oral antidepressant demonstrated with FDA labeling, and the first oral glutamatergic medicine approved for depression,” said Herriot Tabuteau, Chief Executive Officer of Axsome. “Auvelity and the rest of the Axsome neuroscience portfolio reflect our steadfast commitment to developing and delivering potentially life-changing medicines to people living with serious central nervous system disorders.”