Axsome Shares Shoot Higher As FDA Approves Major Depressive Disorder Candidate

The U.S. Food and Drug Administration (FDA) has approved Axsome Therapeutics’ AXSM lead asset AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of major depressive disorder (MDD) in adults.

The AUVELITY New Drug Application (NDA) was evaluated by the agency under Priority Review.

The lead drug was studied in a comprehensive clinical program which included more than 1,100 patients with depression.

The regulatory approval is supported by the efficacy of AUVELITY in the treatment of MDD, demonstrated in the GEMINI placebo-controlled study, and confirmatory evidence which included the ASCEND study comparing AUVELITY to bupropion sustained-release tablets.

Herriot Tabuteau, Chief Executive Officer, commented: "The approval of Auvelity is the culmination of the tremendous and focused research and development activities conducted by the Axsome team and our collaborators. We are extremely proud to deliver this Breakthrough Therapy-designated new treatment to the millions of patients living with depression at a time when it is most needed, given the recent sharp increase in depression prevalence.”

AUVELITY is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of major depressive disorder (MDD).

The agency previously granted Breakthrough Therapy designation to AUVELITY for the treatment of MDD.

The company anticipates AUVELITY to be commercially available in the United States during the fourth quarter of 2022.

Major depressive disorder (MDD) is a debilitating, chronic, biologically-based disorder characterized by low mood, inability to feel pleasure, feelings of guilt and worthlessness, low energy, and other emotional and physical symptoms, and which impairs social, occupational, educational, or other important functioning.

Price Action : Axsome shares are trading around 33 percent higher at $56.50 on Friday during pre-market session.