Axsome Receives FDA Priority Review for AXS-05 Drug
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
0mins
Should l Buy AXSM?
Source: NASDAQ.COM
- Drug Approval Progress: Axsome Therapeutics announced that its AXS-05 drug received FDA priority review designation for treating Alzheimer's disease agitation, with a target action date set for April 30, 2026, providing investors with a shortened timeline for a potential catalyst.
- Significant Sales Growth: Sales of Axsome's Auvelity drug soared 69% in Q3, accounting for 80% of the company's quarterly revenue, demonstrating strong performance in the depression treatment market and further solidifying the company's market position.
- Positive Market Reaction: Following the announcement, Axsome's stock price surged over 20%, remaining up 19.4% as of 12:10 p.m. ET, reflecting strong investor confidence in the company's future prospects.
- New Drug Application Anticipation: Axsome also plans to submit a new drug application for AXS-12 next month, targeting narcolepsy treatment, with FDA meeting minutes indicating that its regulatory data package will be acceptable, providing another potential growth catalyst for the company.
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Analyst Views on AXSM
Wall Street analysts forecast AXSM stock price to rise
13 Analyst Rating
12 Buy
1 Hold
0 Sell
Strong Buy
Current: 182.940
Low
148.00
Averages
196.82
High
248.00
Current: 182.940
Low
148.00
Averages
196.82
High
248.00
About AXSM
Axsome Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of medicines for people living with central nervous system (CNS) conditions. The Company's commercial products include Auvelity, Sunosi and Symbravo. It is also advancing a diversified, late-stage pipeline of product candidates for serious neurological and psychiatric conditions, which include AXS-05, AXS-12, AXS-14 and AXS-17. Auvelity (dextromethorphan-bupropion) is an oral, N-methyl-D-aspartate (NMDA) receptor antagonist with multimodal activity indicated for the treatment of major depressive disorder (MDD). Sunosi (solriamfetol) is an oral medication indicated for the treatment of excessive daytime sleepiness (EDS), in patients with narcolepsy or obstructive sleep apnea. Symbravo (meloxicam and rizatriptan, 20 mg/10mg tablets) is an oral, single-dose medicine approved for the acute treatment of migraine with or without aura in adults.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Axsome Therapeutics Stock Analysis Ahead of Earnings
- Stock Performance: Axsome Therapeutics has been named Friday's IBD Stock of the Day, indicating strong market interest in its future performance, particularly ahead of its upcoming quarterly earnings report.
- Technical Pattern: The stock is forming a three-weeks-tight pattern, suggesting a cautious attitude among investors as they await earnings, which may indicate impending volatility in the stock price.
- Earnings Expectations: With the earnings report approaching, the market is optimistic about Axsome's profitability and future growth potential, with analysts generally positive about the performance of its product line.
- Investor Sentiment: Pre-earnings, investor sentiment appears to be bullish, potentially driving the stock price higher in the short term, reflecting confidence in the company's strategic direction.
See More
Axsome Therapeutics Stock Soars 75% Amid Strong Growth
- Stock Performance: Axsome Therapeutics has seen its stock price surge approximately 75% over the past 12 months, significantly outperforming the S&P 500's 15% increase, indicating strong market confidence in its future prospects.
- Impressive Earnings: In Q3 2025, Axsome reported a 63% year-over-year revenue increase to $171 million, while net losses decreased from $64.6 million to $47.2 million, suggesting positive progress towards profitability.
- Regulatory Catalyst: On December 31, 2025, Axsome's Alzheimer's drug AXS-05 received priority review, with a target action date set for April 30, 2026; the stock jumped 23% on the news, reflecting high market anticipation for the drug's approval.
- Investment Risk Warning: Despite a market cap of $9.4 billion, Axsome remains unprofitable and trades at a high price-to-sales ratio of 16, prompting investors to carefully assess risks, especially given the greater impact of regulatory news on stock price than earnings results.
See More
Analyzing Future Growth Potential of Axsome Therapeutics
- Strong Sales Growth: Axsome Therapeutics reported third-quarter revenue of $171 million, reflecting a 63% year-over-year increase, indicating robust market demand for its drug portfolio, particularly with newly approved products like Symbravo and Auvelity, which are expected to sustain revenue growth.
- New Drug Approval Prospects: The company is pursuing a label expansion for Auvelity in treating Alzheimer's disease (AD) agitation, having shown promising results in phase 3 trials; FDA approval could significantly enhance revenue potential.
- Multiple Clinical Trials Underway: Sunosi has completed a phase 3 study for adults with ADHD, and Axsome plans to conduct further trials in areas like depression with daytime sleepiness, which are anticipated to create new revenue streams for the company.
- Vast Market Opportunities: With over 5 million patients suffering from AD agitation in the U.S. and only one FDA-approved treatment available, Axsome's potential sales in this market could reach billions, highlighting significant growth prospects ahead.
See More
CommVault and Axsome Options Trading Activity Surges
- CommVault Options Volume: Today, CommVault Systems Inc's options volume reached 5,370 contracts, representing approximately 537,000 shares, which constitutes about 92.7% of its average daily trading volume over the past month, indicating heightened market interest in its future performance.
- High Demand for Call Options: Notably, the $90 strike call option expiring on February 20, 2026, saw 1,031 contracts traded today, representing around 103,100 shares, suggesting an increased investor expectation for CommVault's stock price appreciation.
- Axsome Options Volume: Axsome Therapeutics Inc recorded an options trading volume of 7,271 contracts, equating to approximately 727,100 shares, or about 81.4% of its average daily trading volume over the past month, reflecting strong market confidence in its growth potential.
- Strong Performance of Call Options: Particularly, the $280 strike call option expiring on April 17, 2026, traded 5,527 contracts today, representing approximately 552,700 shares, indicating optimistic investor sentiment regarding Axsome's future performance.
See More
Piper Sandler Raises Axsome Therapeutics (AXSM) Price Target to $223, Optimistic on Alzheimer’s Drug Potential
- Price Target Increase: Piper Sandler raised Axsome Therapeutics' price target from $148 to $223 while maintaining an Overweight rating, reflecting strong confidence in Auvelity's potential for FDA label expansion in Alzheimer's agitation.
- Financial Model Update: Baird increased Axsome's price target from $157 to $209 based on an update to its financial model following preliminary Q4 2025 results that slightly exceeded expectations, further boosting market confidence.
- Sales Beat Expectations: Wells Fargo raised Axsome's price target from $157 to $193, noting that Q4 2025 sales for Auvelity and Sunosi surpassed consensus estimates, which is expected to drive continued positive momentum for the stock.
- Increased Success Probability: Wells Fargo raised the probability of success for Alzheimer's Disease Agitation from 75% to 90% following the FDA's decision to grant priority review, indicating optimistic expectations for the drug's future market performance.
See More
Axsome Therapeutics (AXSM) Projects $638.5M Revenue in 2025, $507.1M from Auvelity
- Revenue Growth Projection: Axsome anticipates total product revenue of $638.5 million for 2025, with Auvelity contributing $507.1 million, exceeding analyst expectations of $619.75 million, indicating strong market demand and product potential.
- FDA Expansion Application: The company submitted a label expansion application for Auvelity in December, with the FDA expected to make a decision by April 30, 2026, which could enhance its competitive position in the market for agitation associated with Alzheimer's disease.
- Price Target Increase: Piper Sandler maintained an ‘Overweight’ rating on Axsome, raising its price target from $148 to $223, reflecting confidence in the company's future growth, with the new target representing a potential upside of about 26% from Friday's closing price.
- Positive Market Sentiment: Retail sentiment around AXSM stock on Stocktwits remained in the ‘bullish’ territory over the past 24 hours, despite a decrease in message volume, indicating investor optimism regarding the company's future developments.
See More
Axsome Therapeutics Stock Analysis Ahead of Earnings
- Stock Performance: Axsome Therapeutics has been named Friday's IBD Stock of the Day, indicating strong market interest in its future performance, particularly ahead of its upcoming quarterly earnings report.
- Technical Pattern: The stock is forming a three-weeks-tight pattern, suggesting a cautious attitude among investors as they await earnings, which may indicate impending volatility in the stock price.
- Earnings Expectations: With the earnings report approaching, the market is optimistic about Axsome's profitability and future growth potential, with analysts generally positive about the performance of its product line.
- Investor Sentiment: Pre-earnings, investor sentiment appears to be bullish, potentially driving the stock price higher in the short term, reflecting confidence in the company's strategic direction.
See More
Axsome Therapeutics Stock Soars 75% Amid Strong Growth
- Stock Performance: Axsome Therapeutics has seen its stock price surge approximately 75% over the past 12 months, significantly outperforming the S&P 500's 15% increase, indicating strong market confidence in its future prospects.
- Impressive Earnings: In Q3 2025, Axsome reported a 63% year-over-year revenue increase to $171 million, while net losses decreased from $64.6 million to $47.2 million, suggesting positive progress towards profitability.
- Regulatory Catalyst: On December 31, 2025, Axsome's Alzheimer's drug AXS-05 received priority review, with a target action date set for April 30, 2026; the stock jumped 23% on the news, reflecting high market anticipation for the drug's approval.
- Investment Risk Warning: Despite a market cap of $9.4 billion, Axsome remains unprofitable and trades at a high price-to-sales ratio of 16, prompting investors to carefully assess risks, especially given the greater impact of regulatory news on stock price than earnings results.
See More
Analyzing Future Growth Potential of Axsome Therapeutics
- Strong Sales Growth: Axsome Therapeutics reported third-quarter revenue of $171 million, reflecting a 63% year-over-year increase, indicating robust market demand for its drug portfolio, particularly with newly approved products like Symbravo and Auvelity, which are expected to sustain revenue growth.
- New Drug Approval Prospects: The company is pursuing a label expansion for Auvelity in treating Alzheimer's disease (AD) agitation, having shown promising results in phase 3 trials; FDA approval could significantly enhance revenue potential.
- Multiple Clinical Trials Underway: Sunosi has completed a phase 3 study for adults with ADHD, and Axsome plans to conduct further trials in areas like depression with daytime sleepiness, which are anticipated to create new revenue streams for the company.
- Vast Market Opportunities: With over 5 million patients suffering from AD agitation in the U.S. and only one FDA-approved treatment available, Axsome's potential sales in this market could reach billions, highlighting significant growth prospects ahead.
See More
CommVault and Axsome Options Trading Activity Surges
- CommVault Options Volume: Today, CommVault Systems Inc's options volume reached 5,370 contracts, representing approximately 537,000 shares, which constitutes about 92.7% of its average daily trading volume over the past month, indicating heightened market interest in its future performance.
- High Demand for Call Options: Notably, the $90 strike call option expiring on February 20, 2026, saw 1,031 contracts traded today, representing around 103,100 shares, suggesting an increased investor expectation for CommVault's stock price appreciation.
- Axsome Options Volume: Axsome Therapeutics Inc recorded an options trading volume of 7,271 contracts, equating to approximately 727,100 shares, or about 81.4% of its average daily trading volume over the past month, reflecting strong market confidence in its growth potential.
- Strong Performance of Call Options: Particularly, the $280 strike call option expiring on April 17, 2026, traded 5,527 contracts today, representing approximately 552,700 shares, indicating optimistic investor sentiment regarding Axsome's future performance.
See More
Piper Sandler Raises Axsome Therapeutics (AXSM) Price Target to $223, Optimistic on Alzheimer’s Drug Potential
- Price Target Increase: Piper Sandler raised Axsome Therapeutics' price target from $148 to $223 while maintaining an Overweight rating, reflecting strong confidence in Auvelity's potential for FDA label expansion in Alzheimer's agitation.
- Financial Model Update: Baird increased Axsome's price target from $157 to $209 based on an update to its financial model following preliminary Q4 2025 results that slightly exceeded expectations, further boosting market confidence.
- Sales Beat Expectations: Wells Fargo raised Axsome's price target from $157 to $193, noting that Q4 2025 sales for Auvelity and Sunosi surpassed consensus estimates, which is expected to drive continued positive momentum for the stock.
- Increased Success Probability: Wells Fargo raised the probability of success for Alzheimer's Disease Agitation from 75% to 90% following the FDA's decision to grant priority review, indicating optimistic expectations for the drug's future market performance.
See More
Axsome Therapeutics (AXSM) Projects $638.5M Revenue in 2025, $507.1M from Auvelity
- Revenue Growth Projection: Axsome anticipates total product revenue of $638.5 million for 2025, with Auvelity contributing $507.1 million, exceeding analyst expectations of $619.75 million, indicating strong market demand and product potential.
- FDA Expansion Application: The company submitted a label expansion application for Auvelity in December, with the FDA expected to make a decision by April 30, 2026, which could enhance its competitive position in the market for agitation associated with Alzheimer's disease.
- Price Target Increase: Piper Sandler maintained an ‘Overweight’ rating on Axsome, raising its price target from $148 to $223, reflecting confidence in the company's future growth, with the new target representing a potential upside of about 26% from Friday's closing price.
- Positive Market Sentiment: Retail sentiment around AXSM stock on Stocktwits remained in the ‘bullish’ territory over the past 24 hours, despite a decrease in message volume, indicating investor optimism regarding the company's future developments.
See More
