Axsome Therapeutics Inc (AXSM)

[georgejjl]

Axsome Therapeutics
Only a few days ago, Axsome Therapeutics (AXSM 6.11%) stock was down more than 50% year to date. However, its shares skyrocketed last week after the company revealed that the U.S. Food and Drug Administration (FDA) has proposed labeling for experimental drug AXS-05 in treating major depressive disorder (MDD).

This is an important step toward Axsome potentially winning FDA approval for AXS-05 in the MDD indication. Axsome is also evaluating the drug in a late-stage study for treating Alzheimer's disease agitation. Analysts think the drug could generate peak sales of more than $1 billion if approved.

Axsome is also working with the FDA to resolve chemistry, manufacturing, and controls issues with its regulatory submission for approval of AXS-07 in treating migraine. The company believes the issues are addressable and anticipates "an expeditious resubmission" of the New Drug Application.

In addition, Axsome is acquiring sleep-disorder drug Sunosi from Jazz Pharmaceuticals. Sales for the drug more than doubled in 2021 to $57.9 million.

All of this potentially good news makes Axsome's current market cap of around $1.5 billion look very cheap. This stock appears to have a good chance of delivering strong gains in the second half of 2022.

Good luck and GOD bless,