Axsome (AXSM) Stock; Climbs Nearly 23% After FDA Accelerates Alzheimer’s Review

TLDRs;

• Axsome shares jump nearly 23% as FDA sets April PDUFA date for AXS-05 review.
• AXS-05 seeks to treat Alzheimer’s agitation, potentially competing with existing therapies.
• Analysts lift Axsome target price to $217, citing regulatory momentum and pipeline strength.
• Investors watch FDA timelines, commercial execution, and macro trends for future momentum.

Axsome Therapeutics (NASDAQ: AXSM) saw its shares soar nearly 23% as the U.S. Food and Drug Administration (FDA) granted priority review for the company’s supplemental new drug application (sNDA) for AXS-05, aimed at treating agitation in Alzheimer’s disease.

With the FDA setting an April 30, 2026 Prescription Drug User Fee Act (PDUFA) date, investors responded enthusiastically to the accelerated timeline, reflecting optimism over the therapy’s potential market impact.

On Wednesday, the stock traded between $148.79 and $184.40, closing at $182.64 on a volume of approximately 3.1 million shares, despite U.S. markets being closed Thursday for New Year’s Day.

Axsome Therapeutics, Inc., AXSM

 AXS-05 Targets Unmet Alzheimer’s Need

AXS-05, which combines dextromethorphan and bupropion, is already marketed under the brand name Auvelity for major depressive disorder.

The Alzheimer’s agitation filing represents a strategic expansion of its existing portfolio. According to Axsome CEO Herriot Tabuteau, agitation affects up to 76% of Alzheimer’s patients, highlighting the urgent need for effective treatments.

If approved, AXS-05 would directly compete with Rexulti, which was approved in 2023 as the first therapy targeting agitation in dementia associated with Alzheimer’s disease.

Analysts Raise Price Targets

The regulatory news prompted a notable boost in analyst sentiment. Mizuho’s Graig Suvannavejh raised Axsome’s price target from $202 to $217 while maintaining an Outperform rating.

The recommendation reflects increased confidence in the company’s probability of regulatory success and the commercial potential of AXS-05.

Investors are also watching the company’s investigational therapy AXS-12, designed to treat cataplexy in narcolepsy, which has orphan drug designation and could benefit from market exclusivity if approved. AXS-12’s new drug application submission is expected in January 2026, adding another catalyst for Axsome’s pipeline.

Market and Investor Focus Ahead

Looking forward, traders are monitoring whether Axsome stays on schedule for the April review, along with the outcome of the AXS-12 submission.

Commercial performance of the company’s existing products like Auvelity, Sunosi, and Symbravo, will also influence investor sentiment, as cash burn and payer coverage remain critical factors in biotech risk assessment. Broader macroeconomic trends, including shifts in U.S. yields and upcoming employment data, could further affect growth-stock valuations like Axsome.

With the next earnings report anticipated around February 17, 2026, investors will look for updates on spending priorities, product demand, and guidance on regulatory investments.

The surge in Axsome’s shares illustrates the sensitivity of biotech stocks to regulatory developments. The FDA’s accelerated review not only signals potential near-term value for AXS-05 but also strengthens confidence in the company’s broader pipeline. As U.S. equity markets reopen, attention will turn to whether the stock can maintain its breakout, balancing optimism over regulatory milestones with careful evaluation of market conditions and commercial execution.

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