Axsome Therapeutics is moving ahead with plans to submit its Alzheimer’s disease treatment for Food and Drug Administration approval despite mixed results from two new clinical trial readouts.

“Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term ...

H.C. Wainwright maintained a positive outlook on Axsome Therapeutics (NASDAQ:AXSM), reiterating a Buy stock rating with a ...

Axsome plans to submit an NDA for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from the above controlled and long-term ...

Dec 30 (Reuters) - Axsome Therapeutics (AXSM.O), opens new tab said on Monday it would seek marketing approval next year for its oral drug to treat agitation in patients with Alzheimer's disease ...

Axsome Therapeutics (AXSM – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Ram ...

Axsome plans to submit a new drug application for AXS-05 in Alzheimer’s disease agitation to the FDA in the second half of 2025, based on the efficacy and safety data from these studies.

On Monday, Axsome Therapeutics, Inc. (NASDAQ:AXSM) released data from ACCORD-2, ADVANCE-2, and long-term safety trials AXS-05 (dextromethorphan-bupropion) in Alzheimer's disease agitation.

Axsome Therapeutics has announced positive results from its Phase 3 ACCORD-2 trial for AXS-05, a treatment for agitation associated with Alzheimer's disease. The trial met its primary endpoint ...

NEW YORK, Dec. 30, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics ... and aminoketone CYP2D6 inhibitor, in Alzheimer’s disease agitation, and results of the ACCORD-2, ADVANCE-2, and long-term ...

ACCORD-2 Phase 3 trial in Alzheimer’s disease agitation achieves primary endpoint compared to placebo (p=0.001, time to relapse) ACCORD-2 Phase 3 trial achieves key secondary endpoint compared ...