Axsome's New Drug Application (NDA) for Major Depressive Disorder, has progressed to product labeling discussions with the FDA. This puts Axsome a step closer to potential FDA approval. The company released the following SEC document below.
On June 24, 2022, Axsome Therapeutics, Inc. (the “Company”) received from the U.S. Food and Drug Administration (the “FDA”) proposed labeling for the Company’s AXS-05 product candidate with respect to its New Drug Application (the “NDA”) for AXS-05 for the treatment of major depressive disorder. The Company is reviewing the proposed labeling and will reply to the FDA to secure final labeling agreement.
Axsome's stock had a good week based on the document that the company filed on June 24th, 2022. Weekly chart below, AXSM stock advancing 66.15% under heavy volume.
