FDA Begins Priority Review of Axsome Therapeutics' Potential New Depression Drug

Millions of Americans who experience debilitating bouts of depression could have a new treatment option this summer. On Monday, the FDA began reviewing a New Drug Application from Axsome Therapeutics (NASDAQ:AXSM) for its lead candidate, AXS-05.

Instead of the standard review that takes 10 months, the FDA gave AXS-05 a Priority Review that shaves four months off the process. The agency expects to issue a decision on or before Aug. 22.