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BioWorld - Tuesday, December 16, 2025
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Home » After a year of delay, Axsome’s depression therapy wins US FDA approval
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After a year of delay, Axsome’s depression therapy wins US FDA approval

Aug. 19, 2022
By Lee Landenberger
A year from the U.S. FDA’s August 2021 citation of deficiencies in the labeling for Axsome Therapeutics Inc.’s major depressive disorder therapy, Auvelity (dextromethorphan + bupropion), the agency has approved the drug for use by adults. The New York-based company’s stock (NASDAQ:AXSM) took flight on the news, with shares rising 40% to close at $59.55 Aug. 19, surpassing their previous 52-week high of $48.82 and starkly contrasting with a same-period low of $19.38.
BioWorld Regulatory U.S. FDA

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