NEW YORK, January 1, 2026, 07:18 ET — Market closed
Key points:
- Axsome shares last traded up 22.9% after the FDA granted priority review for an Alzheimer’s agitation filing.
- The FDA set an April 30, 2026 target action date on the AXS-05 supplemental application.
- A Mizuho analyst raised the firm’s price target to $217 after the twin regulatory updates.
With U.S. markets closed on Thursday for the New Year’s Day holiday, Axsome Therapeutics shares were last up 22.9% at $182.64 after the company said the FDA granted priority review for its Alzheimer’s disease agitation filing. The stock swung between $148.79 and $184.40 in Wednesday’s session. Volume was about 3.1 million shares.
Axsome said the FDA accepted for filing its supplemental new drug application (sNDA) for AXS-05 in Alzheimer’s disease agitation and granted Priority Review, which shortens the agency’s target review time to about six months. The FDA set an April 30, 2026 Prescription Drug User Fee Act (PDUFA) date, the deadline when the agency aims to complete its review.
The timing matters because approved options remain scarce; the FDA in 2023 approved Otsuka and Lundbeck’s Rexulti as the first drug to treat agitation symptoms associated with dementia due to Alzheimer’s disease. Axsome’s AXS-05 would compete directly in that market if regulators grant the added label.
AXS-05 combines dextromethorphan and bupropion and is already marketed as Auvelity for major depressive disorder, so the Alzheimer’s agitation bid is an attempt to broaden use of an existing product. “Up to 76% of people with Alzheimer’s disease experience agitation,” CEO Herriot Tabuteau said in the company’s statement. Businessinsider
Axsome also said it received formal pre-New Drug Application meeting minutes from the FDA supporting an NDA submission for AXS-12, an investigational treatment for cataplexy in narcolepsy; cataplexy is a sudden loss of muscle tone often triggered by emotion. The company expects to complete the submission in January 2026 and said AXS-12 has orphan drug designation, which can confer benefits such as market exclusivity if approved.
Mizuho analyst Graig Suvannavejh raised the firm’s price target on Axsome to $217 from $202 and kept an Outperform rating, citing the two regulatory updates and higher probability-of-success assumptions. The stock’s move reflected how quickly sentiment can shift when the FDA puts an accelerated clock on a key review.
What traders watch next is straightforward: evidence that Axsome stays on track toward the April review deadline for AXS-05, and confirmation that an AXS-12 filing lands cleanly with the FDA. Any follow-on disclosures on label scope, safety review focus, or post-marketing requirements could reset expectations quickly.
Investors will also keep an eye on commercial execution in Axsome’s marketed franchise—Auvelity, Sunosi and Symbravo—as the company funds late-stage programs alongside growing sales. In biotech, cash burn and payer coverage can matter as much as pipeline headlines when risk appetite turns.
Before the next session, U.S. equity markets reopen on Friday after the New Year’s Day closure, and traders will gauge whether Wednesday’s breakout holds as liquidity returns.
Axsome has not announced a fourth-quarter earnings date, but Nasdaq estimates the next report around Feb. 17, 2026. Traders will look for updates on 2026 spending, product-demand trends and any guidance that frames how aggressively Axsome invests behind regulatory filings.
Macro can still leak into single-name biotech: shifts in yields often ripple through rate-sensitive growth stocks. The Labor Department’s monthly employment report is scheduled for Jan. 9, a potential volatility point for yields and equity multiples.
On the chart, Wednesday’s high near $184 is the first r
