08:14 AM EST, 12/30/2024 (MT Newswires) -- Axsome Therapeutics ( AXSM ) said Monday it has met the primary endpoint in its ACCORD-2 phase 3 trial of AXS-05, which is intended for Alzheimer's disease agitation, but failed to achieve statistical significance for its primary endpoint in another trial.

Based on the results, the company met its primary endpoint in the ACCORD-2 trial, significantly delaying the time to agitation relapse compared with placebo. It also achieved the key secondary endpoint of preventing agitation relapse.

The trial also showed AXS-05 reduced overall Alzheimer's disease severity compared with placebo, according to the company.

However, Axsome said it failed to show statistical significance for the primary endpoint of its ADVANCE-2 trial, which is the change in the Cohen-Mansfield Agitation Inventory, or CMAI, total score from baseline to the fifth week, but showed numerical improvements favoring the drug candidate.

In both trials, Axsome said AXS-05 was found to be safe and well-tolerated.

The company said it has now completed four pivotal, placebo-controlled phase 3 trials supporting the efficacy and safety of AXS-05 and plans to submit a new drug application to the FDA in H2 2025.

Axsome Therapeutics ( AXSM ) shares were down over 8% in premarket trading.

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