NEW YORK, December 31, 2025, 19:19 ET — After-hours
- Axsome shares jumped nearly 23% after the FDA granted Priority Review for AXS-05 in Alzheimer’s disease agitation.
- The company also said FDA feedback supports an AXS-12 narcolepsy NDA filing in January.
- Traders are now focused on the April 30 FDA target date and the timing of the next submission.
Axsome Therapeutics, Inc. shares jumped 22.9% to $182.64 in after-hours trading on Wednesday after the company said the U.S. Food and Drug Administration accepted its supplemental New Drug Application for AXS-05 to treat agitation linked to Alzheimer’s disease and granted it Priority Review. The agency set an April 30, 2026 target action date, and CEO Herriot Tabuteau said “up to 76% of people with Alzheimer’s disease experience agitation.” GlobeNewswire
The decision matters because Priority Review shortens the FDA’s review timeline, pulling a key regulatory catalyst forward for investors who have been focused on near-term drug-approval outcomes.
For Axsome, a label expansion into Alzheimer’s disease agitation would add a large new commercial opportunity to a product that is already marketed in depression, while putting the company closer to the small group of firms with FDA-cleared options for the condition.
Otsuka and Lundbeck’s Rexulti is currently the first FDA-approved drug for agitation associated with dementia due to Alzheimer’s disease, underscoring how limited approved treatment choices remain in the indication.
A supplemental New Drug Application, or sNDA, is a request to add a new use to an already approved medicine. Priority Review means the FDA aims to act within about six months, compared with about 10 months under a standard review timeline.
Axsome’s commercial base has been growing on the back of its marketed products. In the third quarter, Auvelity net product sales were $136.1 million and Sunosi net product revenue was $32.8 million, the company said previously, alongside disclosure that it had submitted the AXS-05 sNDA in Alzheimer’s disease agitation.
Investors will be watching for any mid-review signals from regulators, including whether the FDA requests additional analyses or convenes an advisory committee meeting, which can affect timelines and expectations.
Axsome also said it received FDA pre-NDA meeting minutes supporting an NDA submission for AXS-12 (reboxetine) for cataplexy in narcolepsy, and expects to complete the filing in January 2026. The company said AXS-12 has Orphan Drug Designation, a status for rare diseases that can provide regulatory incentives such as marketing exclusivity if approved.
The company disclosed both developments in a Form 8-K filing on Wednesday, attaching the press releases as exhibits.
Next on the calendar, investors will look for the planned AXS-12 submission and any subsequent FDA updates as the AXS-05 review proceeds toward the late-April target date. Axsome is also expected to report quarterly results around Feb. 17, according to Nasdaq’s earnings calendar estimates.
U.S. equities markets are closed Thursday for New Year’s Day and reopen on Friday, Jan. 2, which could delay the stock’s next regular-session reaction to Wednesday’s regulatory news.
Axsome traded between $148.79 and $184.40 on Wednesday, leaving the day’s high as a near-term level for momentum-focused traders and the prior-close area as a key test if gains fade when regular trading resumes.
With the FDA clock now running, investors will be watching for further regulatory communications and updates on commercial demand for Axsome’s marketed portfolio as 2026 begins.
