NEW YORK, January 1, 2026, 16:58 ET — Market closed
Axsome Therapeutics shares jumped about 23% in the most recent session on Wednesday after the company said the U.S. Food and Drug Administration accepted its supplemental application for AXS-05 to treat agitation in Alzheimer’s disease and granted the filing priority review. The stock last traded at $182.64, after swinging between $148.79 and $184.40 on volume of about 3.1 million shares. 1
Why it matters now: priority review shortens the FDA’s review target to six months, versus 10 months under the standard process, pulling a key binary catalyst into the first half of 2026. Investors often reprice drug developers quickly when regulators put a hard decision date on a major program. 2
The filing also lands in a narrow competitive lane. Otsuka Pharmaceutical and Lundbeck’s Rexulti is the first FDA-approved treatment for agitation associated with dementia due to Alzheimer’s disease, leaving limited on-label competition if Axsome clears the agency. 3
“We are very pleased the FDA has accepted and granted priority review to our supplemental NDA,” Chief Executive Herriot Tabuteau said. The company said AXS-05 combines dextromethorphan and bupropion and is already sold in the U.S. as Auvelity for major depressive disorder; the Alzheimer’s agitation use would be a label expansion via a supplemental New Drug Application, or sNDA. 4
Axsome also disclosed separate regulatory progress on AXS-12, saying FDA pre-NDA meeting minutes support an NDA filing for cataplexy in narcolepsy and that submission is on track for January 2026. Cataplexy is a sudden loss of muscle tone, often triggered by strong emotions, and the company said AXS-12 has FDA orphan-drug designation, which can confer benefits such as potential market exclusivity if approved. 5
On the Street, Mizuho analyst Graig Suvannavejh raised Axsome’s price target to $217 from $202 and kept an Outperform rating, citing the two “positive regulatory” updates and higher probability-of-success assumptions for both assets, according to a note carried by The Fly. 6
The sharp move underscores how quickly sentiment can shift in single-product biotech when a regulatory timeline tightens. For Axsome, investors are now weighing the odds of an expansion for its flagship dextromethorphan-bupropion franchise against the execution risks that come with late-stage CNS drug reviews.
U.S. stock markets are closed Thursday for the New Year’s Day holiday and are set to reopen Friday. 7
Before the next session, traders will watch for any added detail around the timing and contents of the AXS-12 filing and whether the FDA signals any additional data needs once the package is submitted, given the company’s own caution that acceptance depends on the final filing review.
A larger marker sits further out: the FDA’s April 30 target action date for AXS-05, which puts label language and safety discussions in focus as the review advances. The company’s next quarterly update is also a near-term swing factor for positioning, though Axsome has not announced a date; MarketBeat lists an estimated report date of Feb. 17. 8
Technically, investors will be watching whether AXSM holds above the $150 area that roughly matched Wednesday’s session low and the prior close, after the stock’s jump pushed it into the low-$180s.
