Axsome Therapeutics Plans New Drug Application for AXS-12 in January, Shares Surge 16.1%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
0mins
Should l Buy AXSM?
Source: Benzinga
- New Drug Application Plan: Axsome Therapeutics announced its intention to file a new drug application for AXS-12 in January after receiving FDA feedback, which is expected to enhance the company's market share in the mental health sector.
- Priority Review Approval: The FDA granted Priority Review for AXS-05 for Alzheimer's agitation, which will expedite the product's market entry and could lead to significant revenue growth for the company.
- Significant Stock Surge: Axsome Therapeutics' shares rose 16.1% to $172.90 on Wednesday, reflecting strong market confidence in its drug development prospects, potentially attracting more investor interest.
- Positive Market Reaction: Amid a broader market decline, Axsome's stock increased, indicating investor optimism in the biotech sector, which may pave the way for future financing and partnership opportunities for the company.
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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: 163.190
Low
153.00
Averages
209.54
High
260.00
Current: 163.190
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.
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- 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
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- 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
Wall Street Analysts Adjust Ratings on Key Stocks
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several stocks, including upgrades, downgrades, and initiations, reflecting varying market perspectives that could influence investor decisions.
- Market Dynamics: As analysts revise their outlook on THRM stock, investors may consider buying or selling, potentially impacting its market performance and liquidity, thereby increasing market uncertainty.
- Impact of Rating Changes: Changes in analyst ratings often have a direct effect on stock prices, prompting investors to closely monitor these shifts to timely adjust their investment strategies and optimize their portfolios.
- Source of Information: This information is provided by Benzinga, highlighting the significance of analyst ratings in investment decisions, and investors should reference these ratings for a more comprehensive market view.
See More
Axsome Reports Q4 Revenue Exceeding Expectations
- Significant Revenue Growth: Axsome reported total net product revenue of $196 million for Q4, reflecting a 65% year-over-year increase and surpassing analysts' expectations of $192.82 million, indicating strong performance in major depressive disorder treatment AUVELITY and the newly launched acute migraine treatment SYMBRAVO.
- Lower-than-Expected Loss: The company reported a net loss of $0.56 per share for Q4, which was better than the analyst estimate of a loss of $0.78 per share, showcasing effective financial management and boosting investor confidence.
- Optimistic Cash Flow Outlook: With cash and cash equivalents totaling $322.9 million at the end of 2025, Axsome believes its current cash is sufficient to fund anticipated operations until cash flow positivity, demonstrating financial stability.
- Upcoming FDA Decision: The FDA is expected to decide on Axsome's application for AXS-05 in Alzheimer’s Disease Agitation by April 30, while the company plans to initiate a trial for AXS-05 in smoking cessation in Q2 2026, further expanding its product pipeline.
See More
Axsome Therapeutics Q4 2025 Earnings Call Highlights
- Significant Sales Growth: Axsome Therapeutics reported total revenue of $196 million for Q4 2025, reflecting a 65% year-over-year increase, with full-year revenue reaching $639 million, indicating strong market performance and the potential for multibillion-dollar sales.
- Product Performance Highlights: AUVELITY achieved net sales of $155.1 million in Q4, up 68% year-over-year, while SUNOSI generated $36.7 million in net revenue, and SYMBRAVO contributed $4.1 million in its second full quarter, demonstrating increasing market acceptance of new products.
- R&D and Market Expansion: The company plans to initiate multiple Phase III clinical trials in 2026 and is expanding its sales force for AUVELITY in Alzheimer's disease agitation to about 600 representatives, expected to be completed in Q2, further enhancing its competitive position.
- Financial Health Status: Despite a net loss of $28.6 million in Q4, or $0.56 per share, the company ended the year with $323 million in cash and cash equivalents, indicating a solid financial foundation to support future growth and R&D investments.
See More
