01:42 PM EST, 03/03/2025 (MT Newswires) -- Axsome Therapeutics ( AXSM ) said Monday it received feedback from the US Food and Drug Administration supporting a submission of its drug for Alzheimer's disease agitation for approval.

Meeting minutes from the company's pre-new drug application huddle with the FDA indicated that the company's regulatory data package for AXS-05 would support a supplemental new drug application, the company said.

The company said it anticipates making such a submission in Q3.

The treatment holds the FDA's breakthrough therapy designation and will be eligible for a priority review, Axsome noted.

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