Why Axsome Therapeutics (AXSM) Shares Are Trading Higher Premarket Today - Axsome Therapeutics (NASDAQ:AXSM)

The FDA has approved Axsome Therapeutics Inc's AXSM Auvelity (dextromethorphan HBr -bupropion HCl) extended-release tablets for major depressive disorder (MDD) in adults.
Auvelity is the first and only rapid-acting oral medicine approved for the treatment of MDD with the labeling of statistically significant antidepressant efficacy compared to placebo starting at one week.
Related: Axsome Therapeutics Rallies 40% On FDA Product Label Proposal, But Analyst Remains Skeptical.
The rapid antidepressant effects of Auvelity have been sustained at all subsequent time points.
Auvelity is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for treating MDD.
Axsome anticipates Auvelity to be commercially available in the U.S. in Q4 of 2022.
The product is protected by a robust patent estate extending to at least 2037-2040 and was studied in a comprehensive clinical program that included more than 1,100 depression patients.
Price Action: AXSM shares are up 26.10% at $53.50 during the premarket session on the last check Friday.

Axsome's Depression Candidate Scores FDA Nod, Stock Surges To 52-High