Why Is Axsome Therapeutics (AXSM) Stock Shooting Higher On Monday? - Axsome Therapeutics (NASDAQ:AXSM)

Axsome Therapeutics Inc AXSM stock is rising in premarket due to an update for its US marketing application seeking approval for AXS-05 for major depressive disorder (MDD).
The FDA informed that it would not meet the target action date of August 22 for the application.
Investors are probably cheering because the agency did not ask for any additional information, and the application review is ongoing.
Related Content: Axsome received an FDA letter for the AXS-05 application for MDD, citing deficiencies that preclude discussion of labeling and post-marketing requirements/commitments.
AXS-05 (dextromethorphan-bupropion) is an NMDA receptor antagonist with multimodal activity under development to treat MDD and other central nervous system disorders.
Related content: Benzinga's Full FDA Calendar.
Price Action: AXSM shares are up 22.70% at $26.46 during the premarket session on the last check Monday.