Axsome Therapeutics receives FDA Priority Review for AXS-05
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
0mins
Should l Buy AXSM?
Axsome Therapeutics Inc. saw a significant price increase of 17.59%, crossing above the 5-day SMA, amidst a slight decline in the broader market with the Nasdaq-100 down 0.22% and the S&P 500 down 0.15%.
This surge is attributed to the FDA granting Priority Review for Axsome's supplemental NDA for AXS-05, with a target action date set for April 30, 2026. This expedited review process addresses the urgent medical needs of Alzheimer's patients experiencing agitation, potentially filling a critical market gap and enhancing Axsome's competitive position in the CNS sector.
The implications of this development are significant, as the approval of AXS-05 could lead to substantial revenue growth for Axsome, given the high demand for effective treatments in the Alzheimer's space. This move further solidifies Axsome's leadership in the biopharmaceutical industry.
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Analyst Views on AXSM
Wall Street analysts forecast AXSM stock price to rise
15 Analyst Rating
14 Buy
1 Hold
0 Sell
Strong Buy
Current: 166.340
Low
153.00
Averages
209.54
High
260.00
Current: 166.340
Low
153.00
Averages
209.54
High
260.00
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.
Undervalued Investment Opportunities: Axsome and Madrigal
- Axsome's Growth Potential: Axsome Therapeutics' stock has more than doubled over the past five years, primarily due to clinical and commercial progress with its leading candidate Auvelity, with new approvals and label expansions expected to significantly enhance financial performance and potentially lead to profitability in the next five years.
- Significant Revenue Increase: In 2025, Axsome's revenue surged by 66% to $638.5 million, while its net loss per share improved to $3.68 from $5.99 in 2024, indicating strong performance in large, underserved markets.
- Madrigal's FDA Approval: Madrigal Pharmaceuticals received FDA approval for Rezdiffra in 2024, the first drug indicated for metabolic dysfunction-associated steatohepatitis, generating $958.4 million in revenue last year, highlighting robust market demand.
- Huge Market Demand: Madrigal targets 315,000 patients, having treated about 36,250 so far, indicating significant market potential in the MASH area, with prospects for sustained financial growth and competitive returns in the future.
See More
Axsome and Madrigal's Market Potential
- Axsome's Growth Potential: Axsome Therapeutics' stock has more than doubled over the past five years, primarily due to clinical and commercial progress with its leading candidate Auvelity, which is expected to significantly improve financial performance through new approvals and label expansions over the next five years.
- Significant Revenue Increase: In 2025, Axsome's revenue surged by 66% to $638.5 million, and although the net loss per share was $3.68, it showed improvement compared to the $5.99 loss per share reported in 2024, indicating potential for profitability.
- Madrigal's Market Breakthrough: Madrigal Pharmaceuticals received FDA approval for Rezdiffra in 2024, the first drug indicated for metabolic dysfunction-associated steatohepatitis, generating $958.4 million in revenue last year solely from this product, highlighting strong market demand.
- Unmet Medical Needs: Madrigal has treated approximately 36,250 patients, targeting 315,000, indicating a significant unmet need in the metabolic dysfunction-associated steatohepatitis space, which is likely to drive continued financial growth.
See More
Axsome Therapeutics CEO Sells Shares Amid Expiring Options
- Insider Share Sale: Axsome Therapeutics CEO Herriot Tabuteau exercised and sold 32,410 common shares on February 2, 2026, totaling $6 million, reducing his direct holdings by 81.76% to just 7,229 shares, which may indicate a waning confidence in the company's future prospects.
- Transaction Context: The sale was prompted by the exercise of options nearing expiration, with all shares sold immediately in the open market, indicating that Tabuteau did not engage in any new direct or indirect share grants or purchases, reflecting a cautious stance towards the market.
- Company Financials: With a market capitalization of $8.37 billion and a 66% year-over-year growth in net product revenue for 2025, Axsome Therapeutics demonstrates strong performance in the CNS drug market, despite a net income loss of $183.2 million, attracting growth-oriented investors.
- FDA Review Progress: The FDA has granted Priority Review for AXS-05 targeting Alzheimer's disease agitation, with a decision expected by April 30, 2026, marking a pivotal moment that could significantly impact the company's future revenue and profitability outlook.
See More
Helus Pharma's Psychedelic Drug Achieves Phase 3 Success
- Clinical Trial Breakthrough: Helus Pharma's SPL026 demonstrated significant efficacy in a randomized controlled trial for treatment-resistant depression, with a MADRS score difference of -7.35 (p=0.023) among 34 participants, providing clinical proof-of-concept that could shift regulatory and investor perspectives on psychedelic applications in psychiatry.
- Production Quota Increase: The DEA raised the 2026 psilocybin production quota by 67%, creating larger market opportunities for companies like Helus Pharma and accelerating their research and development efforts in psychedelic therapies.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement of its multi-asset clinical pipeline, particularly for key assets like HLP003 and HLP004.
- Optimistic Future Outlook: HLP003 has shown a 100% response rate and 71% remission rate in two pivotal Phase 3 studies, with topline data expected in Q4 2026, further solidifying Helus Pharma's market position in depression treatment.
See More
Helus Pharma Achieves Breakthrough in Depression Treatment
- Clinical Trial Success: Helus Pharma's SPL026 achieved significant results in a Phase 2 trial for treatment-resistant depression, with a mean MADRS difference of -7.35 (p=0.023) among 34 participants receiving a 21.5 mg dose, indicating strong efficacy and market potential for the drug.
- FDA Breakthrough Therapy: Helus's HLP003 has received FDA Breakthrough Therapy designation and is undergoing two pivotal Phase 3 trials, with early data showing 100% response rates and 71% remission at 12 months, potentially offering new treatment options for depression and solidifying the company's position in the psychiatric drug market.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing robust financial support for the continued advancement of its multi-asset clinical pipeline, ensuring the company can maintain its competitive edge in a rapidly evolving market.
- Significant Market Potential: The World Health Organization estimates that depression and anxiety cost the global economy over $1 trillion annually in lost productivity, positioning Helus Pharma's innovative drugs to meet this substantial market demand and drive future growth and investment appeal.
See More
UBS Increases Target Price for AXSOME THERAPEUTICS INC to $251, Up from $248
- Company Overview: Athera Therapeutics has raised its target price to $251 from $248.
- Market Impact: This adjustment reflects a positive outlook on the company's performance and potential growth.
See More
Undervalued Investment Opportunities: Axsome and Madrigal
- Axsome's Growth Potential: Axsome Therapeutics' stock has more than doubled over the past five years, primarily due to clinical and commercial progress with its leading candidate Auvelity, with new approvals and label expansions expected to significantly enhance financial performance and potentially lead to profitability in the next five years.
- Significant Revenue Increase: In 2025, Axsome's revenue surged by 66% to $638.5 million, while its net loss per share improved to $3.68 from $5.99 in 2024, indicating strong performance in large, underserved markets.
- Madrigal's FDA Approval: Madrigal Pharmaceuticals received FDA approval for Rezdiffra in 2024, the first drug indicated for metabolic dysfunction-associated steatohepatitis, generating $958.4 million in revenue last year, highlighting robust market demand.
- Huge Market Demand: Madrigal targets 315,000 patients, having treated about 36,250 so far, indicating significant market potential in the MASH area, with prospects for sustained financial growth and competitive returns in the future.
See More
Axsome and Madrigal's Market Potential
- Axsome's Growth Potential: Axsome Therapeutics' stock has more than doubled over the past five years, primarily due to clinical and commercial progress with its leading candidate Auvelity, which is expected to significantly improve financial performance through new approvals and label expansions over the next five years.
- Significant Revenue Increase: In 2025, Axsome's revenue surged by 66% to $638.5 million, and although the net loss per share was $3.68, it showed improvement compared to the $5.99 loss per share reported in 2024, indicating potential for profitability.
- Madrigal's Market Breakthrough: Madrigal Pharmaceuticals received FDA approval for Rezdiffra in 2024, the first drug indicated for metabolic dysfunction-associated steatohepatitis, generating $958.4 million in revenue last year solely from this product, highlighting strong market demand.
- Unmet Medical Needs: Madrigal has treated approximately 36,250 patients, targeting 315,000, indicating a significant unmet need in the metabolic dysfunction-associated steatohepatitis space, which is likely to drive continued financial growth.
See More
Axsome Therapeutics CEO Sells Shares Amid Expiring Options
- Insider Share Sale: Axsome Therapeutics CEO Herriot Tabuteau exercised and sold 32,410 common shares on February 2, 2026, totaling $6 million, reducing his direct holdings by 81.76% to just 7,229 shares, which may indicate a waning confidence in the company's future prospects.
- Transaction Context: The sale was prompted by the exercise of options nearing expiration, with all shares sold immediately in the open market, indicating that Tabuteau did not engage in any new direct or indirect share grants or purchases, reflecting a cautious stance towards the market.
- Company Financials: With a market capitalization of $8.37 billion and a 66% year-over-year growth in net product revenue for 2025, Axsome Therapeutics demonstrates strong performance in the CNS drug market, despite a net income loss of $183.2 million, attracting growth-oriented investors.
- FDA Review Progress: The FDA has granted Priority Review for AXS-05 targeting Alzheimer's disease agitation, with a decision expected by April 30, 2026, marking a pivotal moment that could significantly impact the company's future revenue and profitability outlook.
See More
Helus Pharma's Psychedelic Drug Achieves Phase 3 Success
- Clinical Trial Breakthrough: Helus Pharma's SPL026 demonstrated significant efficacy in a randomized controlled trial for treatment-resistant depression, with a MADRS score difference of -7.35 (p=0.023) among 34 participants, providing clinical proof-of-concept that could shift regulatory and investor perspectives on psychedelic applications in psychiatry.
- Production Quota Increase: The DEA raised the 2026 psilocybin production quota by 67%, creating larger market opportunities for companies like Helus Pharma and accelerating their research and development efforts in psychedelic therapies.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash, ensuring continued advancement of its multi-asset clinical pipeline, particularly for key assets like HLP003 and HLP004.
- Optimistic Future Outlook: HLP003 has shown a 100% response rate and 71% remission rate in two pivotal Phase 3 studies, with topline data expected in Q4 2026, further solidifying Helus Pharma's market position in depression treatment.
See More
Helus Pharma Achieves Breakthrough in Depression Treatment
- Clinical Trial Success: Helus Pharma's SPL026 achieved significant results in a Phase 2 trial for treatment-resistant depression, with a mean MADRS difference of -7.35 (p=0.023) among 34 participants receiving a 21.5 mg dose, indicating strong efficacy and market potential for the drug.
- FDA Breakthrough Therapy: Helus's HLP003 has received FDA Breakthrough Therapy designation and is undergoing two pivotal Phase 3 trials, with early data showing 100% response rates and 71% remission at 12 months, potentially offering new treatment options for depression and solidifying the company's position in the psychiatric drug market.
- Strong Financial Backing: As of December 31, 2025, Helus Pharma reported $195.1 million in cash reserves, providing robust financial support for the continued advancement of its multi-asset clinical pipeline, ensuring the company can maintain its competitive edge in a rapidly evolving market.
- Significant Market Potential: The World Health Organization estimates that depression and anxiety cost the global economy over $1 trillion annually in lost productivity, positioning Helus Pharma's innovative drugs to meet this substantial market demand and drive future growth and investment appeal.
See More
UBS Increases Target Price for AXSOME THERAPEUTICS INC to $251, Up from $248
- Company Overview: Athera Therapeutics has raised its target price to $251 from $248.
- Market Impact: This adjustment reflects a positive outlook on the company's performance and potential growth.
See More
