Axsome Shares Climb on FDA Fast‑Track for Alzheimer's Drug, Backing for Narcolepsy Filing
By Adriano Marchese
Axsome Therapeutics shares rose Wednesday morning after the Food and Drug Administration gave its Alzheimer's disease drug priority review designation and supported its application for its narcolepsy treatment.
Shares rose 17% to $173.52.
The biopharmaceutical company accepted for filing a supplemental new drug application for AXS-05 to treat Alzheimer's disease agitation, and has granted the application priority review designation, which shortens the regulator's review time for a new drug.
The FDA plans to make its decision by April 30.
The company was also provided with formal pre-new drug application meeting minutes from the regulator which supports a submission for the new drug, AXS-12.
AXS-12 aims to treat narcolepsy, a chronic neurological sleep disorder that causes extreme sleepiness where affected individuals can fall asleep suddenly and without warning.
Axsome said its current submission package is already sufficient, and that it plans to complete the new drug application submission in January.
Write to Adriano Marchese at adriano.marchese@wsj.com
(END) Dow Jones Newswires
December 31, 2025 10:19 ET (15:19 GMT)
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