Benzinga | Apr 26, 2021 07:54AM EDT

Axsome Therapeutics Stock Jumps As FDA Accepts AXS-05 Application In Major Depressive Disorder

* Under Priority review status, the FDA has accepted Axsome Therapeutics Inc's (NASDAQ: AXSM) marketing application for AXS-05 for major depressive disorder (MDD).

* The target action date is set at August 22.

* AXS-05 (dextromethorphan-bupropion) is an oral, investigational NMDA receptor antagonist with multimodal activity.

* Priority Review designation accelerates the review time from 10 months to a goal of six months from the date of acceptance of the filing.

* The FDA had previously granted Breakthrough Therapy Designation for AXS-05 to treat MDD and Alzheimer's disease agitation.

* The NDA is supported by results from two trials, the GEMINI and ASCEND, which demonstrated statistically significant improvements in depressive symptoms with AXS-05 compared to placebo and active controls.

* Price Action: AXSM shares are up 12.9% at $59.7 in the premarket trading on the last check Monday.