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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