Axsome Seen Getting a Boost from Potential Approvals -- Market Talk

Dow Jones01-03

1457 ET - Axsome Therapeutics could continue to gain traction this year with two potential approvals on deck, Baird analysts say in a note. The Food and Drug Administration accepted the company's new drug application for an Alzheimer's agitation treatment with priority review, and looks likely to approve it, the analysts say. "We believe the clinical package is sufficiently robust for approval, particularly within the context of the FDA's move toward requiring fewer pivotal studies for approval," they say. The company is also likely to submit an application for a narcolepsy treatment after receiving meeting minutes from the FDA, they say. "These developments set up two potential approvals in 2026 to add to the building momentum of Axsome's commercial franchises," they say.(kelly.cloonan@wsj.com)

(END) Dow Jones Newswires

January 02, 2026 14:58 ET (19:58 GMT)

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The Food and Drug Administration accepted the company's new drug application for an Alzheimer's agitation treatment with priority review, and looks likely to approve it, the analysts say. \"We believe the clinical package is sufficiently robust for approval, particularly within the context of the FDA's move toward requiring fewer pivotal studies for approval,\" they say. 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