Axsome Therapeutics (AXSM) has received formal pre-New Drug Application meeting minutes from the U.S. Food and Drug Administration supporting a ...

Based on the feedback from the FDA, the Company’s regulatory data package would be sufficient for the submission of an sNDA for AXS-05 for the treatment of Alzheimer’s disease agitation. Axsome ...

Axsome Therapeutics AXSM announced that it has received formal feedback from the FDA on its plans to seek approval for AXS-05 ...

William Blair sees Axsome’s AXS-05 as a unique drug with strong safety advantages. Analyst Myles Minter is optimistic about its approval chances, citing positive results from the ADVANCE-1 ...

Axsome Therapeutics’ AXSM Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio ...

It is also developing AXS-05 (dextromethorphan-bupropion), an investigational N-methyl-D-aspartate receptor antagonist, which has completed Phase III clinical trial to treat Alzheimer's disease ...

Successful completion of Phase 3 clinical program of AXS-05 in Alzheimer’s disease agitation announced; NDA submission anticipated in 2H 2025 Positive topline results of ENCORE Phase 3 trial of ...

AXS-05 (dextromethorphan-bupropion) is a novel, oral, investigational NMDA receptor antagonist, sigma-1 agonist, and aminoketone CYP2D6 inhibitor. The purpose of the meeting was to reach agreement ...

Axsome Therapeutics AXSM announced that it has received formal feedback from the FDA on its plans to seek approval for AXS-05 as a treatment for agitation in Alzheimer’s disease (AD) patients.