The FDA gave priority review to an application seeking approval of AXS-05 for Alzheimer's-related agitation, with a decision date of April 30.

After Axsome Therapeutics (AXSM) reported topline data from the studies of AXS-05 in Alzheimer’s disease agitation, Truist analyst Joon Lee noted that while the ADVANCE-2 study missed statistical ...

On Tuesday, Axsome Therapeutics Inc (NASDAQ:AXSM) reported fourth-quarter 2024 revenues of $118.77 million, up from $71.53 million a year ago, beating the consensus of $117.64 million. Auvelity (oral ...

Shares of Axsome Therapeutics AXSM were up 22.8% on Dec. 31, after it announced that the FDA had accepted the supplemental new drug application (“sNDA”) seeking approval for AXS-05 (dextromethorphan ...

FDA grants Priority Review to AXS-05 (dextromethorphan/bupropion) for the treatment of agitation associated with Alzheimer disease.

FDA grants AXS-05 Priority Review designation and sets PDUFA action goal date of April 30, 2026 NEW YORK, Dec. 31, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a ...

NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today ...

Axsome Therapeutics shows strong revenue growth from Auvelity and Sunosi, with promising late-stage pipeline drugs for migraine, fibromyalgia, and narcolepsy. Late-stage pipeline milestones include ...

AXS-05 met the primary endpoint by substantially and statistically significantly delaying the time to relapse of Alzheimer’s disease agitation as compared to placebo (hazard ratio for time to relapse ...