Tonix Pharmaceuticals Presents Fibromyalgia Study Data at ASCP 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Source: Newsfilter
- Current Drug Usage: In the 2023-2024 study, 40.2% of 261,776 fibromyalgia patients with Commercial or Medicare Advantage insurance were prescribed at least one opioid, indicating a persistent reliance on opioids despite existing guidelines discouraging their use.
- Patient Demographics: The study revealed that the average age of fibromyalgia patients was 52.3 years, with 92.1% being female, and opioid use was highest among older age groups, reaching 43.1% in those aged 61-65, highlighting the urgent need for effective pain management in older patients.
- Impact of New Drug Launch: Tonix's TONMYA®, launched in 2025, is the first new fibromyalgia drug approved in the U.S. in over 15 years, aiming to provide effective non-opioid treatment options that could transform patient care and reduce opioid dependence.
- Significant Educational Need: The CEO of Tonix emphasized the gap between clinical practice and evidence-based recommendations, indicating an urgent need to educate healthcare providers about fibromyalgia and the availability of non-opioid medications to improve overall patient health outcomes.
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Analyst Views on TNXP
Wall Street analysts forecast TNXP stock price to rise
2 Analyst Rating
2 Buy
0 Hold
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Moderate Buy
Current: 12.640
Low
65.00
Averages
67.50
High
70.00
Current: 12.640
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 Presents Fibromyalgia Study Data at ASCP 2026
- Current Drug Usage: In the 2023-2024 study, 40.2% of 261,776 fibromyalgia patients with Commercial or Medicare Advantage insurance were prescribed at least one opioid, indicating a persistent reliance on opioids despite existing guidelines discouraging their use.
- Patient Demographics: The study revealed that the average age of fibromyalgia patients was 52.3 years, with 92.1% being female, and opioid use was highest among older age groups, reaching 43.1% in those aged 61-65, highlighting the urgent need for effective pain management in older patients.
- Impact of New Drug Launch: Tonix's TONMYA®, launched in 2025, is the first new fibromyalgia drug approved in the U.S. in over 15 years, aiming to provide effective non-opioid treatment options that could transform patient care and reduce opioid dependence.
- Significant Educational Need: The CEO of Tonix emphasized the gap between clinical practice and evidence-based recommendations, indicating an urgent need to educate healthcare providers about fibromyalgia and the availability of non-opioid medications to improve overall patient health outcomes.
See More
Tonix Pharmaceuticals to Participate in Upcoming Investor Conferences
- Investor Conference Participation: Tonix Pharmaceuticals will participate in two investor conferences on May 19 and 20, 2026, led by CEO Dr. Seth Lederman, aimed at enhancing the company's visibility in the biotechnology sector.
- Conference Details: The RBC Capital Markets Global Healthcare Conference will take place in New York on May 19, while the G.P. Annual Virtual Healthcare Conference will be held online on May 20, expected to attract significant investor interest.
- Product Development Progress: Tonix's TONMYA® is the first new treatment for fibromyalgia in over 15 years, currently undergoing clinical trials to evaluate its potential in major depressive disorder and acute stress reactions, highlighting the company's strategic focus on addressing high unmet medical needs.
- Advancement of Immunology Programs: The company is advancing immunology projects such as TNX-4800, a monoclonal antibody for Lyme disease prevention, and TNX-1500, a CD154/CD40 ligand inhibitor for preventing kidney transplant rejection, indicating Tonix's diversified strategic positioning in the biopharmaceutical field.
See More
Strong First Quarter Performance for TONMYA Post-Launch
- Prescription Growth: In the first full quarter since the launch of TONMYA, 2,145 healthcare providers prescribed the medication, with 3,588 patients initiating treatment and approximately 5,400 prescriptions filled, indicating strong market acceptance and patient demand, which suggests potential market share growth in fibromyalgia treatment.
- Strategic Partnership Expansion: In May 2026, the company signed an agreement with a leading group purchasing organization, providing access to TONMYA for approximately 35 million U.S. commercial lives, enhancing patient accessibility and expected to drive sales growth and brand recognition.
- Clinical Research Plans: The company anticipates initiating an adaptive Phase 2 field study for TNX-4800, a novel monoclonal antibody for Lyme disease prevention, in the first half of 2027, pending FDA agreement, which could open new revenue streams if approved.
- Strong Financial Position: As of March 31, 2026, the company reported approximately $185.5 million in cash and cash equivalents, and despite an increase in operational expenses to about $42.3 million, the $22.6 million raised through market financing will support future R&D and market expansion plans, ensuring ongoing operational capability in the competitive biotechnology sector.
See More
Tonmya Receives FDA Approval, New Option for Fibromyalgia Treatment
- FDA Approval Milestone: Tonmya has become the first FDA-approved treatment for fibromyalgia in over 15 years, representing a significant advancement in non-opioid therapies for chronic pain management, which is expected to enhance patient quality of life.
- Market Access Expansion: The new agreement with a major purchasing organization broadens Tonmya's coverage to approximately 35 million commercially insured patients in the U.S., significantly increasing the drug's market accessibility and likely driving revenue growth for the company.
- Patient Support Commitment: Tonix is dedicated to improving patient access to Tonmya by engaging with commercial payers and offering a patient support program, addressing the dissatisfaction experienced by 85% of patients with first-line treatments due to efficacy and tolerability issues, thereby enhancing patient satisfaction.
- Future Research Initiatives: Tonix is also advancing clinical trials for TNX-4800, with plans to have drug supplies ready by 2027, which is expected to provide new treatment options for Lyme disease prevention, further expanding the company's product portfolio.
See More
Tonix Pharmaceuticals Secures Coverage for Tonmya with GPO Agreement
- Agreement Reached: Tonix Pharmaceuticals has entered into an agreement with a group purchasing organization to secure commercial payer coverage for its non-opioid pain therapy, Tonmya, which is expected to cover approximately 35 million U.S. commercial lives, accounting for about one-fifth of the total U.S. commercial lives.
- Market Potential Unveiled: The agreement took effect on May 1, marking Tonix's first partnership in managed care, with CEO Seth Lederman expressing optimism about this collaboration and looking forward to expanding coverage across commercial and government channels.
- Medicare Coverage Status: Tonmya, a sublingual tablet formulation, is currently covered under Medicare in 38 states, involving nearly 55 million Medicaid members, which constitutes 73% of the approximately 75 million members of the joint federal and state healthcare plan, indicating its broad acceptance in the healthcare market.
- Expansion Discussions Ongoing: Tonix is currently in discussions with Medicare and Medicaid to widen the coverage for Tonmya, which is expected to support future revenue growth for the company and enhance its competitive position in the pain management market.
See More
Tonix Pharmaceuticals Reports Wider Q1 Loss and Revenue Decline
- Revenue Overview: Tonix Pharmaceuticals reported a net revenue of $8.3 million for Q1 2026, with approximately $3.7 million coming from its newly launched drug Tonmya, indicating growth but significant loss pressures remain.
- Widening Loss Expectations: The company anticipates a preliminary net loss of about $40.8 million for Q1 2026, a stark increase from the $16.8 million loss reported in the same quarter of 2025, highlighting challenges in drug promotion and market acceptance.
- Strong Cash Position: As of the end of Q1, Tonix held approximately $185.5 million in cash and cash equivalents, along with $17.4 million raised in April 2026, which is expected to sustain operations until Q2 2027, ensuring continued investment in R&D and marketing.
- Market Sentiment Analysis: Despite a 25% decline in TNXP's stock over the past year, retail sentiment on Stocktwits remains bearish, although some users believe the company's early 2026 performance is misunderstood, reflecting potential confidence in future growth.
See More
Tonix Pharmaceuticals Presents Fibromyalgia Study Data at ASCP 2026
- Current Drug Usage: In the 2023-2024 study, 40.2% of 261,776 fibromyalgia patients with Commercial or Medicare Advantage insurance were prescribed at least one opioid, indicating a persistent reliance on opioids despite existing guidelines discouraging their use.
- Patient Demographics: The study revealed that the average age of fibromyalgia patients was 52.3 years, with 92.1% being female, and opioid use was highest among older age groups, reaching 43.1% in those aged 61-65, highlighting the urgent need for effective pain management in older patients.
- Impact of New Drug Launch: Tonix's TONMYA®, launched in 2025, is the first new fibromyalgia drug approved in the U.S. in over 15 years, aiming to provide effective non-opioid treatment options that could transform patient care and reduce opioid dependence.
- Significant Educational Need: The CEO of Tonix emphasized the gap between clinical practice and evidence-based recommendations, indicating an urgent need to educate healthcare providers about fibromyalgia and the availability of non-opioid medications to improve overall patient health outcomes.
See More
Tonix Pharmaceuticals to Participate in Upcoming Investor Conferences
- Investor Conference Participation: Tonix Pharmaceuticals will participate in two investor conferences on May 19 and 20, 2026, led by CEO Dr. Seth Lederman, aimed at enhancing the company's visibility in the biotechnology sector.
- Conference Details: The RBC Capital Markets Global Healthcare Conference will take place in New York on May 19, while the G.P. Annual Virtual Healthcare Conference will be held online on May 20, expected to attract significant investor interest.
- Product Development Progress: Tonix's TONMYA® is the first new treatment for fibromyalgia in over 15 years, currently undergoing clinical trials to evaluate its potential in major depressive disorder and acute stress reactions, highlighting the company's strategic focus on addressing high unmet medical needs.
- Advancement of Immunology Programs: The company is advancing immunology projects such as TNX-4800, a monoclonal antibody for Lyme disease prevention, and TNX-1500, a CD154/CD40 ligand inhibitor for preventing kidney transplant rejection, indicating Tonix's diversified strategic positioning in the biopharmaceutical field.
See More
Strong First Quarter Performance for TONMYA Post-Launch
- Prescription Growth: In the first full quarter since the launch of TONMYA, 2,145 healthcare providers prescribed the medication, with 3,588 patients initiating treatment and approximately 5,400 prescriptions filled, indicating strong market acceptance and patient demand, which suggests potential market share growth in fibromyalgia treatment.
- Strategic Partnership Expansion: In May 2026, the company signed an agreement with a leading group purchasing organization, providing access to TONMYA for approximately 35 million U.S. commercial lives, enhancing patient accessibility and expected to drive sales growth and brand recognition.
- Clinical Research Plans: The company anticipates initiating an adaptive Phase 2 field study for TNX-4800, a novel monoclonal antibody for Lyme disease prevention, in the first half of 2027, pending FDA agreement, which could open new revenue streams if approved.
- Strong Financial Position: As of March 31, 2026, the company reported approximately $185.5 million in cash and cash equivalents, and despite an increase in operational expenses to about $42.3 million, the $22.6 million raised through market financing will support future R&D and market expansion plans, ensuring ongoing operational capability in the competitive biotechnology sector.
See More
Tonmya Receives FDA Approval, New Option for Fibromyalgia Treatment
- FDA Approval Milestone: Tonmya has become the first FDA-approved treatment for fibromyalgia in over 15 years, representing a significant advancement in non-opioid therapies for chronic pain management, which is expected to enhance patient quality of life.
- Market Access Expansion: The new agreement with a major purchasing organization broadens Tonmya's coverage to approximately 35 million commercially insured patients in the U.S., significantly increasing the drug's market accessibility and likely driving revenue growth for the company.
- Patient Support Commitment: Tonix is dedicated to improving patient access to Tonmya by engaging with commercial payers and offering a patient support program, addressing the dissatisfaction experienced by 85% of patients with first-line treatments due to efficacy and tolerability issues, thereby enhancing patient satisfaction.
- Future Research Initiatives: Tonix is also advancing clinical trials for TNX-4800, with plans to have drug supplies ready by 2027, which is expected to provide new treatment options for Lyme disease prevention, further expanding the company's product portfolio.
See More
Tonix Pharmaceuticals Secures Coverage for Tonmya with GPO Agreement
- Agreement Reached: Tonix Pharmaceuticals has entered into an agreement with a group purchasing organization to secure commercial payer coverage for its non-opioid pain therapy, Tonmya, which is expected to cover approximately 35 million U.S. commercial lives, accounting for about one-fifth of the total U.S. commercial lives.
- Market Potential Unveiled: The agreement took effect on May 1, marking Tonix's first partnership in managed care, with CEO Seth Lederman expressing optimism about this collaboration and looking forward to expanding coverage across commercial and government channels.
- Medicare Coverage Status: Tonmya, a sublingual tablet formulation, is currently covered under Medicare in 38 states, involving nearly 55 million Medicaid members, which constitutes 73% of the approximately 75 million members of the joint federal and state healthcare plan, indicating its broad acceptance in the healthcare market.
- Expansion Discussions Ongoing: Tonix is currently in discussions with Medicare and Medicaid to widen the coverage for Tonmya, which is expected to support future revenue growth for the company and enhance its competitive position in the pain management market.
See More
Tonix Pharmaceuticals Reports Wider Q1 Loss and Revenue Decline
- Revenue Overview: Tonix Pharmaceuticals reported a net revenue of $8.3 million for Q1 2026, with approximately $3.7 million coming from its newly launched drug Tonmya, indicating growth but significant loss pressures remain.
- Widening Loss Expectations: The company anticipates a preliminary net loss of about $40.8 million for Q1 2026, a stark increase from the $16.8 million loss reported in the same quarter of 2025, highlighting challenges in drug promotion and market acceptance.
- Strong Cash Position: As of the end of Q1, Tonix held approximately $185.5 million in cash and cash equivalents, along with $17.4 million raised in April 2026, which is expected to sustain operations until Q2 2027, ensuring continued investment in R&D and marketing.
- Market Sentiment Analysis: Despite a 25% decline in TNXP's stock over the past year, retail sentiment on Stocktwits remains bearish, although some users believe the company's early 2026 performance is misunderstood, reflecting potential confidence in future growth.
See More
