Axsome Therapeutics Inc’s (AXSM) AXS-05, proposed for the treatment of major depressive disorder, is under priority review by the FDA, with a decision expected on August 22.AXS-05 is a fixed-dose combination of two approved drugs - bupropion and dextromethorphan - and utilizes Axsome’s metabolic inhibition technology.In two pivotal trials, in patients with a confirmed diagnosis of moderate to severe major depressive disorder, AXS-05 demonstrated rapid, substantial, and statistically significant reductions in depressive symptoms compared to placebo.There are a number of approved drugs to treat major depressive disorder. According to GlobalData, the major depressive disorder (MDD) market is expected to grow from $3.97 billion in 2019 to $7.87 billion by 2029.Myles Minter, analyst at William Blair, expects AXS-05 to achieve peak annual sales of $900 million in the indication of MDD, if approved.AXSM closed Monday’s (Jul.26, 2021) trading at $51.79, down 3.52%.