Claim 70% Off TipRanks Premium
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Stay ahead of the market with the latest news and analysis and maximize your portfolio's potential
The latest update is out from Axsome Therapeutics ( (AXSM) ).
On December 31, 2025, Axsome Therapeutics reported that the U.S. Food and Drug Administration had provided formal pre-New Drug Application meeting minutes supporting the company’s planned NDA submission for AXS-12 (reboxetine) for the treatment of cataplexy in narcolepsy, confirming that its regulatory data package should be sufficient to file. Axsome said it remained on track to complete the AXS-12 NDA submission in January 2026, a key step in potentially adding a differentiated orphan drug to its CNS portfolio, which could strengthen its competitive position in the narcolepsy market and, if ultimately approved, secure seven years of U.S. marketing exclusivity and relief from FDA user fees, with meaningful implications for future revenue and cost structure.
The most recent analyst rating on (AXSM) stock is a Buy with a $157.00 price target. To see the full list of analyst forecasts on Axsome Therapeutics stock, see the AXSM Stock Forecast page.
Spark’s Take on AXSM Stock
According to Spark, TipRanks’ AI Analyst, AXSM is a Neutral.
Axsome Therapeutics’ overall stock score is driven by strong revenue growth and positive technical indicators. However, financial performance is hindered by high leverage, negative profitability, and cash flow challenges. The earnings call provides optimism with strategic R&D advancements and commercial execution, but valuation concerns persist due to ongoing net losses.
To see Spark’s full report on AXSM stock, click here.
More about Axsome Therapeutics
Axsome Therapeutics is a New York-based biopharmaceutical company focused on central nervous system disorders, with an industry-leading neuroscience portfolio that includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine. The company targets significant unmet needs in neurological and psychiatric conditions affecting over 150 million people in the U.S., and is advancing multiple late-stage programs, including AXS-12 for narcolepsy, which has Orphan Drug Designation and patent protection extending to at least 2039.
Average Trading Volume: 512,922
Technical Sentiment Signal: Buy
Current Market Cap: $7.6B
Find detailed analytics on AXSM stock on TipRanks’ Stock Analysis page.