NEW YORK, January 1, 2026, 03:20 ET — Market closed
Axsome Therapeutics Inc shares jumped 22.9% to $182.64 in Wednesday’s session, after touching $184.40, with about 3.1 million shares traded. The CNS drugmaker said the U.S. Food and Drug Administration accepted and granted priority review to its supplemental new drug application for AXS-05 (dextromethorphan-bupropion) — marketed as Auvelity for major depressive disorder — for agitation in Alzheimer’s disease, setting an April 30 action date. “Up to 76% of people with Alzheimer’s disease experience agitation, representing a significant unmet medical need,” Chief Executive Herriot Tabuteau said. GlobeNewswire
The priority review gives investors a near-term FDA deadline to trade around and compresses the regulatory timeline, a key driver for biotech names where a single decision can reset growth expectations.
Axsome also said it received formal FDA pre-NDA meeting minutes supporting a planned new drug application for AXS-12 (reboxetine) for cataplexy — sudden episodes of muscle weakness — in narcolepsy, and expects to complete the filing in January. Orphan Drug Designation for AXS-12, reserved for diseases affecting fewer than 200,000 people in the United States, can offer incentives such as seven years of market exclusivity if approved, the company said.
Priority review is the FDA’s expedited process for drugs that may offer significant improvements; the agency’s goal is to act within six months versus 10 months under standard review, and the designation does not change the approval standard, the FDA says.
A supplemental NDA is a request to add a new use to a drug that’s already on the market. The PDUFA date — named for the user-fee law that funds reviews — is the agency’s target deadline for a decision.
The U.S. has one drug approved specifically for agitation symptoms associated with dementia due to Alzheimer’s disease: Otsuka Pharmaceutical and Lundbeck’s Rexulti, the FDA said in 2023.
For Axsome, an expansion into Alzheimer’s-related agitation would broaden Auvelity’s footprint beyond depression and deepen its exposure to central nervous system disorders.
Traders will be watching for the AXS-12 filing to be formally submitted and accepted for review, and for any updates as the FDA works through the AXS-05 application on its priority review clock.
Before the next session, U.S. stock markets reopen on Friday after the New Year’s Day holiday closure.
Friday’s U.S. schedule includes weekly jobless claims and construction spending figures, followed by the ISM manufacturing survey early next week, data points that can move rates and swing appetite for high-growth healthcare names.
Axsome has not confirmed its next earnings date, but MarketBeat’s earnings calendar estimates Feb. 17 based on past reporting dates. Investors typically use that report for updates on Auvelity demand, spending levels and cash runway.
