Axsome's long delayed depression drug is back up for label discussions at the FDA, triggering a big spike in the share price
Axsome’s on-and-off quest to obtain an FDA approval for their depression drug AXS-05 is back on again.
After the markets closed on Monday, the biotech issued a short, simple alert in an SEC filing saying the team had “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.”
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