Analyst Confidence Soars for Axsome Therapeutics (NASDAQ:AXSM) Amidst Regulatory Progress and Clinical Trial Expansion

Font: Financial Modeling Prep  • Jul 20, 2026

• Analyst firm BMO Capital has set a new, higher price target for Axsome Therapeutics, reflecting strong confidence and significant growth potential for the stock.
• The U.S. Food and Drug Administration (FDA) has accepted Axsome's New Drug Application for AXS-12, a key regulatory milestone for its narcolepsy treatment.
• Axsome is expanding its clinical development pipeline, initiating a Phase III study for solriamfetol in treating ADHD in children.

Axsome Therapeutics (NASDAQ:AXSM) is a biopharmaceutical company focused on developing new medicines for central nervous system (CNS) disorders. These are conditions that affect the brain and spinal cord. The company currently has a market capitalization, which is the total value of all its shares, of approximately $11.41 billion.

Reflecting a positive outlook, BMO Capital analyst Malcolm Hoffman sets a new price target of $310 for Axsome. At the time of this rating, the stock was priced at $221.64. This new target suggests a potential increase of about 39.87% for the stock's value, indicating strong confidence in the company's future.

This optimism is supported by recent regulatory progress. As highlighted by Zacks, the U.S. Food and Drug Administration (FDA) accepted Axsome's New Drug Application for AXS-12. This drug is intended to treat cataplexy in narcolepsy. A final decision from the FDA on the application is anticipated by May 1, 2027.

The company is also expanding its clinical trials. Axsome has started its Phase III FOCUS-2 study, which tests solriamfetol for treating ADHD in children. This is a late-stage trial designed to confirm a drug's safety and effectiveness before it can be approved for sale to the public.

The stock's performance has been strong, with shares rallying 30.1% year-to-date, which is much higher than the industry's 1.9% rise. Over the past 52 weeks, the stock has traded between a low of $96.09 and a high of $260.19, showing significant price movement and investor interest.