Tonix Receives FDA Clearance for Phase 2 Study of TNX-102 SL in Major Depressive Disorder
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 24 2025
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Should l Buy TNXP?
Source: Newsfilter
- Clinical Trial Launch: Tonix Pharmaceuticals announced FDA clearance to initiate the pivotal Phase 2 HORIZON study of TNX-102 SL in mid-2026 for adults with major depressive disorder. The study aims to enroll approximately 360 patients to assess the drug's efficacy and safety.
- Market Demand: Over 21 million adults in the U.S. experience a major depressive episode each year, highlighting the urgent need for innovative treatment options. TNX-102 SL's unique pharmacological profile targets sleep disturbances associated with depression, potentially offering new therapeutic avenues for patients.
- Study Design: The HORIZON study will utilize a randomized, double-blind, placebo-controlled design, with the primary endpoint being the change in MADRS score over six weeks. This design will help Tonix validate TNX-102 SL as a first-line monotherapy, advancing its application in the depression market.
- Drug Background: TNX-102 SL is a sublingual tablet that has shown potential in improving depressive symptoms in studies for fibromyalgia and PTSD. The drug's patent protection is expected to last until 2034, potentially providing Tonix with a competitive edge in the depression treatment landscape.
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Analyst Views on TNXP
Wall Street analysts forecast TNXP stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 15.100
Low
65.00
Averages
67.50
High
70.00
Current: 15.100
Low
65.00
Averages
67.50
High
70.00
About TNXP
Tonix Pharmaceuticals Holding Corp. is a biopharmaceutical company focused on developing and commercializing therapeutics to treat and vaccines to prevent, disease and alleviate suffering. Its development portfolio is focused on central nervous system (CNS) disorders. Its product candidates include TNX-102 SL, TNX-1300, TNX-2900, TNX-1900, TNX-1500, TNX-801, TNX-1800, TNX-4200, and TNX-1700. TNX-102 SL is for the management of fibromyalgia. Its CNS portfolio includes TNX-1300 (cocaine esterase), a biologic designed to treat cocaine intoxication that has a therapy designation. Its immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. It markets Zembrace SymTouch (sumatriptan injection) 3 mg and Tosymra (sumatriptan nasal spray) 10 mg.
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.
Tonix Pharmaceuticals Reports Positive Phase 3 Clinical Data for TONMYA
- Successful Phase 3 Trial: Tonix Pharmaceuticals presented positive data for TONMYA at the Non-Opioid Pain Therapeutics Summit in Boston, demonstrating its significant pain reduction capabilities, thereby reinforcing its position as a non-opioid treatment option.
- Patient Recruitment and Study Design: The RESILIENT trial was a 14-week, randomized, double-blind, placebo-controlled study conducted at 34 U.S. sites, enrolling 456 participants who met the 2016 American College of Rheumatology criteria for fibromyalgia, ensuring the reliability of the results.
- Side Effects and Tolerability: TONMYA was well tolerated, with a discontinuation rate due to adverse events of 6.1% in the treatment group compared to 3.5% in the placebo group, and most adverse events were mild oral reactions, indicating its safety profile.
- Market Outlook and Approval Information: TONMYA received FDA approval in August 2025 and became commercially available in the U.S. in November 2025, marking the first new prescription medicine for fibromyalgia in over 15 years, expected to meet the treatment needs of over 10 million adults in the U.S.
See More
TONMYA Shows Significant Pain Reduction in Fibromyalgia Treatment
- Clinical Trial Results: At the 2026 Non-Opioid Pain Therapeutics Summit, TONMYA demonstrated a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) compared to placebo in the RESILIENT study, with an effect size of 0.38, indicating its efficacy in treating fibromyalgia.
- Unique Dosing Method: TONMYA's sublingual formulation is designed for nighttime administration, bypassing first-pass metabolism to optimize drug exposure during sleep while limiting daytime exposure to the active metabolite, enhancing the overall treatment experience for patients.
- Good Tolerability: The study showed that TONMYA was well tolerated, with an adverse event-related discontinuation rate of 6.1%, lower than the 3.5% for placebo, and the most common adverse events were mild oral reactions, indicating a favorable safety profile.
- Market Demand Alignment: With over 10 million adults in the U.S. affected by fibromyalgia and existing treatments often limited by tolerability, the introduction of TONMYA provides an effective non-opioid alternative, addressing the urgent market need for new therapies.
See More
Tonix Pharmaceuticals to Present at January 2026 Investor Conferences
- Investor Conference Schedule: Tonix Pharmaceuticals will present at the Neuroscience Innovation Forum and Biotech Showcase on January 11 and 13, 2026, showcasing innovations in neuropsychiatric drug development, which is expected to attract potential investor interest.
- Leadership Participation: CEO Seth Lederman, M.D. will lead multiple sessions, emphasizing the company's leadership in biotechnology, aiming to enhance Tonix's market visibility and investor confidence.
- Product Line Showcase: Tonix will highlight its FDA-approved non-opioid analgesic TONMYA and other acute migraine treatments, demonstrating its market potential in chronic pain and CNS disorders.
- R&D Investment Outlook: Tonix's development pipeline includes candidates for rare diseases and infectious diseases, which is expected to generate interest in biotech investments and further enhance the company's competitiveness in the industry.
See More
Tonix Pharmaceuticals (TNXP) Enters $20M Securities Purchase Agreement with Point72
- Securities Purchase Agreement: Tonix Pharmaceuticals has entered into a securities purchase agreement with Point72 for the sale of 615,025 shares at $16.26 each, expected to close around December 30, subject to customary conditions, which will generate approximately $20 million in gross proceeds to enhance the company's liquidity for future R&D support.
- Pre-Funded Warrant Structure: In addition to common stock, the agreement includes pre-funded warrants allowing the purchase of 615,025 shares at $16.259 each, optimizing the financing structure and reducing overall financing costs for the company.
- Underwriter Role: TD Cowen is acting as the sole placement agent for this transaction, while A.G.P./Alliance Global Partners serves as financial advisor, ensuring smooth execution and boosting market confidence, reflecting investor trust in Tonix's future prospects.
- Funding Utilization Outlook: This financing will provide Tonix with essential capital to support ongoing investments in clinical trials and product development, particularly for the upcoming Phase 2/3 trial of TNX-4800, potentially driving long-term growth for the company.
See More
Tonix Pharmaceuticals Advances TNX-4800 for Lyme Disease with 2027 Testing Timeline
- Vaccine Development Progress: Tonix Pharmaceuticals announced that TNX-4800 (formerly mAb 2217LS), a monoclonal antibody targeting Lyme disease, is in development with investigational product expected for testing under Good Manufacturing Practices (GMP) by early 2027, addressing the lack of effective vaccines in the U.S. market.
- FDA Meeting Plans: The company plans to meet with the FDA in 2026 to discuss Phase 2/3 development options for TNX-4800, which could provide a pre-exposure prophylaxis solution for approximately 70 million potential beneficiaries, highlighting significant public health implications.
- Funding Raise: Concurrently, Tonix announced a securities purchase agreement with Point72 for 615,025 shares at $16.26 each, with gross proceeds expected to be around $20 million, which will be used for product commercialization and pipeline development, enhancing the company's financial stability.
- Market Reaction: Tonix Pharmaceuticals' stock rose 0.80% to $16.39 at the time of the announcement, reflecting positive market sentiment regarding its vaccine development progress, which may boost investor confidence.
See More
Tonix Pharmaceuticals Enters $20M Stock Purchase Agreement with Point72 for 615,025 Shares
- Financing Agreement Reached: Tonix Pharmaceuticals has signed a securities purchase agreement with Point72 to sell 615,025 shares of common stock at $16.26 per share, with expected gross proceeds of approximately $20 million, enhancing the company's liquidity to support product commercialization.
- Clear Use of Funds: The proceeds from this offering will be utilized to fund the commercialization of marketed products, the development of its product pipeline, and general working capital, ensuring the company's sustained growth and competitiveness in the biotechnology sector.
- Innovative Transaction Structure: In addition to common stock, the agreement includes pre-funded warrants allowing the purchase of the same number of common shares, further enhancing investor participation flexibility and attracting more capital investment.
- Positive Market Reaction: The transaction is expected to close on December 30, 2025, subject to customary closing conditions, and the market holds an optimistic view on Tonix's prospects, potentially driving stock price increases and boosting investor confidence.
See More
Tonix Pharmaceuticals Reports Positive Phase 3 Clinical Data for TONMYA
- Successful Phase 3 Trial: Tonix Pharmaceuticals presented positive data for TONMYA at the Non-Opioid Pain Therapeutics Summit in Boston, demonstrating its significant pain reduction capabilities, thereby reinforcing its position as a non-opioid treatment option.
- Patient Recruitment and Study Design: The RESILIENT trial was a 14-week, randomized, double-blind, placebo-controlled study conducted at 34 U.S. sites, enrolling 456 participants who met the 2016 American College of Rheumatology criteria for fibromyalgia, ensuring the reliability of the results.
- Side Effects and Tolerability: TONMYA was well tolerated, with a discontinuation rate due to adverse events of 6.1% in the treatment group compared to 3.5% in the placebo group, and most adverse events were mild oral reactions, indicating its safety profile.
- Market Outlook and Approval Information: TONMYA received FDA approval in August 2025 and became commercially available in the U.S. in November 2025, marking the first new prescription medicine for fibromyalgia in over 15 years, expected to meet the treatment needs of over 10 million adults in the U.S.
See More
TONMYA Shows Significant Pain Reduction in Fibromyalgia Treatment
- Clinical Trial Results: At the 2026 Non-Opioid Pain Therapeutics Summit, TONMYA demonstrated a statistically significant reduction in weekly average pain scores at Week 14 (p<0.0001) compared to placebo in the RESILIENT study, with an effect size of 0.38, indicating its efficacy in treating fibromyalgia.
- Unique Dosing Method: TONMYA's sublingual formulation is designed for nighttime administration, bypassing first-pass metabolism to optimize drug exposure during sleep while limiting daytime exposure to the active metabolite, enhancing the overall treatment experience for patients.
- Good Tolerability: The study showed that TONMYA was well tolerated, with an adverse event-related discontinuation rate of 6.1%, lower than the 3.5% for placebo, and the most common adverse events were mild oral reactions, indicating a favorable safety profile.
- Market Demand Alignment: With over 10 million adults in the U.S. affected by fibromyalgia and existing treatments often limited by tolerability, the introduction of TONMYA provides an effective non-opioid alternative, addressing the urgent market need for new therapies.
See More
Tonix Pharmaceuticals to Present at January 2026 Investor Conferences
- Investor Conference Schedule: Tonix Pharmaceuticals will present at the Neuroscience Innovation Forum and Biotech Showcase on January 11 and 13, 2026, showcasing innovations in neuropsychiatric drug development, which is expected to attract potential investor interest.
- Leadership Participation: CEO Seth Lederman, M.D. will lead multiple sessions, emphasizing the company's leadership in biotechnology, aiming to enhance Tonix's market visibility and investor confidence.
- Product Line Showcase: Tonix will highlight its FDA-approved non-opioid analgesic TONMYA and other acute migraine treatments, demonstrating its market potential in chronic pain and CNS disorders.
- R&D Investment Outlook: Tonix's development pipeline includes candidates for rare diseases and infectious diseases, which is expected to generate interest in biotech investments and further enhance the company's competitiveness in the industry.
See More
Tonix Pharmaceuticals (TNXP) Enters $20M Securities Purchase Agreement with Point72
- Securities Purchase Agreement: Tonix Pharmaceuticals has entered into a securities purchase agreement with Point72 for the sale of 615,025 shares at $16.26 each, expected to close around December 30, subject to customary conditions, which will generate approximately $20 million in gross proceeds to enhance the company's liquidity for future R&D support.
- Pre-Funded Warrant Structure: In addition to common stock, the agreement includes pre-funded warrants allowing the purchase of 615,025 shares at $16.259 each, optimizing the financing structure and reducing overall financing costs for the company.
- Underwriter Role: TD Cowen is acting as the sole placement agent for this transaction, while A.G.P./Alliance Global Partners serves as financial advisor, ensuring smooth execution and boosting market confidence, reflecting investor trust in Tonix's future prospects.
- Funding Utilization Outlook: This financing will provide Tonix with essential capital to support ongoing investments in clinical trials and product development, particularly for the upcoming Phase 2/3 trial of TNX-4800, potentially driving long-term growth for the company.
See More
Tonix Pharmaceuticals Advances TNX-4800 for Lyme Disease with 2027 Testing Timeline
- Vaccine Development Progress: Tonix Pharmaceuticals announced that TNX-4800 (formerly mAb 2217LS), a monoclonal antibody targeting Lyme disease, is in development with investigational product expected for testing under Good Manufacturing Practices (GMP) by early 2027, addressing the lack of effective vaccines in the U.S. market.
- FDA Meeting Plans: The company plans to meet with the FDA in 2026 to discuss Phase 2/3 development options for TNX-4800, which could provide a pre-exposure prophylaxis solution for approximately 70 million potential beneficiaries, highlighting significant public health implications.
- Funding Raise: Concurrently, Tonix announced a securities purchase agreement with Point72 for 615,025 shares at $16.26 each, with gross proceeds expected to be around $20 million, which will be used for product commercialization and pipeline development, enhancing the company's financial stability.
- Market Reaction: Tonix Pharmaceuticals' stock rose 0.80% to $16.39 at the time of the announcement, reflecting positive market sentiment regarding its vaccine development progress, which may boost investor confidence.
See More
Tonix Pharmaceuticals Enters $20M Stock Purchase Agreement with Point72 for 615,025 Shares
- Financing Agreement Reached: Tonix Pharmaceuticals has signed a securities purchase agreement with Point72 to sell 615,025 shares of common stock at $16.26 per share, with expected gross proceeds of approximately $20 million, enhancing the company's liquidity to support product commercialization.
- Clear Use of Funds: The proceeds from this offering will be utilized to fund the commercialization of marketed products, the development of its product pipeline, and general working capital, ensuring the company's sustained growth and competitiveness in the biotechnology sector.
- Innovative Transaction Structure: In addition to common stock, the agreement includes pre-funded warrants allowing the purchase of the same number of common shares, further enhancing investor participation flexibility and attracting more capital investment.
- Positive Market Reaction: The transaction is expected to close on December 30, 2025, subject to customary closing conditions, and the market holds an optimistic view on Tonix's prospects, potentially driving stock price increases and boosting investor confidence.
See More
