AXSM - Axsome gains 19% as FDA approves depression therapy

• The shares of Axsome Therapeutics ( NASDAQ: AXSM ) added ~19% in the pre-market trading Friday after the U.S. biopharma company announced the approval of Auvelity extended-release tablets for adults with the major depressive disorder (MDD).
• According to the company, Auvelity, also known as dextromethorphan HBr -bupropion HCl is the first and only rapid-acting oral treatment, approved with labeling to indicate that it leads to statistically significant antidepressant effects against placebo starting at one week.
• “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.” AXSM CEO Herriot Tabuteau noted.
• The company plans to begin U.S. commercialization of the drug in Q4 2022.

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