A Key FDA Verdict On This Firm’s Alzheimer’s Drug Is Scheduled This Week – Stock Has Already Gained Nearly 15% In A Month

• Axsome’s supplemental new drug application for AXS-05 was accepted by the FDA last December.
• The drug could be used in about 76% of Alzheimer’s patients who experience agitation, including symptoms like distress, irritability, and aggressive behavior.
• AXS-05 is protected by patents that extend to at least 2043.

Axsome Therapeutics (AXSM) is drawing investor attention on Wednesday as the biotech firm heads into a critical moment, with the U.S. Food and Drug Administration set to deliver its decision on the company’s Alzheimer’s agitation treatment later this week.

Last December, the FDA accepted Axsome’s supplemental new drug application (sNDA) for AXS-05, granted it Priority Review, and set a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2026.

A PDUFA date is the FDA’s target date for making a decision on a drug application, which allows the drug to be marketed in the U.S.

The sNDA was based on a full clinical program, including four late-stage controlled studies and a long-term safety trial.

AXSM shares were up around 1% in pre-market trading and have gained nearly 15% over the past month.

What Is Alzheimer’s Agitation?

Alzheimer’s disease (AD), the leading cause of dementia, impacts roughly seven million people in the U.S., the company said. Around 76% of the patients with AD experience agitation, which can show up as distress, irritability, or aggressive behavior. This condition is tied to quicker mental decline, increased pressure on caregivers, earlier institutional care, and a higher mortality risk.

Axsome’s AXS-05 is an oral, experimental drug being developed not only to treat agitation in Alzheimer’s disease but also to help people quit smoking, with a pivotal Phase 2/3 trial expected to begin in the second quarter (Q2) of 2026. It combines dextromethorphan and bupropion in a single formulation and is protected by patents that extend to at least 2043.

What’s Retail Saying?

Retail sentiment on Stocktwits remained in the ‘bullish’ territory over the past 24 hours, amid ‘high’ message volumes.

One investor expressed confidence that the company will secure FDA approval and believes the stock could rise by around 20%.

Another user pointed out that the company has been expanding its sales team over the past six months in anticipation of a potential FDA approval for AXS-05, while questioning whether the added costs could weigh on earnings.

The stock has seen a steady 22% growth so far this year.

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