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 ...

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 ...

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 is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in ...

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.

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 ...

Axsome management will then host a conference ... to help increase awareness and understanding of the challenges Alzheimer’s disease (AD) presents to patients, their caregivers, and their ...

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 ...