Tonix Pharmaceuticals Secures Second Commercial Payer Agreement for TONMYA®, Expanding Total Commercial Coverage to ~52 Million U.S. Lives
Rhea-AI Summary
Tonix Pharmaceuticals (Nasdaq: TNXP) signed a second commercial payer agreement for TONMYA, effective June 1, 2026, via a leading GPO. The deal adds coverage for ~17 million U.S. commercial lives, bringing total commercial coverage to ~52 million lives, about 29% of U.S. commercial lives.
TONMYA, a cyclobenzaprine HCl sublingual tablet and first new fibromyalgia medicine for adults in over 15 years approved by the FDA, also has Medicaid coverage in most states representing ~75 million lives. A TONMYA Together Support Program offers savings for eligible commercially insured patients.
AI-generated analysis. Not financial advice.
Positive
- Second GPO agreement adds access for approximately 17 million U.S. commercial lives
- Total TONMYA commercial coverage reaches about 52 million lives, or 29% of U.S. commercial lives
- First GPO agreement covers approximately 35 million lives, effective May 1, 2026
- TONMYA available under Medicaid in most states, totaling about 75 million lives
- TONMYA is described as first new FDA‑approved fibromyalgia medicine for adults in over 15 years
- TONMYA Together Support Program provides savings for eligible commercially insured patients
Negative
- Medicare coverage for TONMYA not yet secured, with discussions reported as ongoing
Market Reaction – TNXP
Following this news, TNXP has gained 6.14%, reflecting a notable positive market reaction. Our momentum scanner has triggered 2 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $11.75. This price movement has added approximately $10M to the company's valuation.
Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.
Key Figures
Market Reality Check
Peers on Argus
TNXP was down 6.82% while key biotech peers like NMRA (-6.86%), CADL (-7.3%), OMER (-4.35%) and VNDA (-4.13%) also declined. Momentum scanner did not flag a coordinated sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| 2026-05-28 | Claims analysis data | Positive | -2.5% | Real-world analysis on opioid and benzodiazepine use in fibromyalgia adults. |
| 2026-05-27 | Phase 1 data TNX-1500 | Positive | -4.9% | Phase 1 TNX-1500 results showing tolerability and Phase 2 readiness. |
| 2026-05-26 | Claims burden study | Positive | +0.0% | ISPOR presentation on fibromyalgia comorbidity and healthcare resource use. |
| 2026-05-14 | ISPOR poster preview | Positive | +1.8% | Announcement of upcoming ISPOR 2026 poster linked to TONMYA. |
| 2026-05-12 | Investor conferences | Positive | +4.2% | Participation in two May 2026 healthcare investor conferences. |
Recent positive scientific and commercial updates have often seen mixed-to-negative next-day price reactions, with several divergences between upbeat news and share performance.
Over the last month, Tonix has highlighted multiple milestones: real‑world fibromyalgia claims analyses (May 14–28, 2026), positive Phase 1 data for transplant candidate TNX‑1500 (May 27, 2026), and investor conference participation (May 12, 2026). Despite generally constructive news flow around TONMYA’s launch and pipeline progress, next‑day price moves were often negative or muted. Today’s expansion of TONMYA coverage to ~52 million commercial lives fits this pattern of fundamentally positive updates amid a volatile trading backdrop.
Regulatory & Risk Context
Tonix has an active S-3/A shelf filed on 2025-09-04, currently noted as not effective. The amendment cited in the summary re-filed Exhibit 23.1 without changing the prospectus. Shelf usage includes at least one 424B5 filing on 2025-11-21.
Market Pulse Summary
This announcement expands TONMYA’s commercial footprint, adding roughly 17 million covered lives through a second GPO and bringing total U.S. commercial coverage to about 52 million (~29% of commercial lives), alongside Medicaid access for approximately 75 million lives. It builds on TONMYA’s position as the first new adult fibromyalgia medicine in over 15 years. In evaluating impact, investors may track prescription trends, further payer agreements, and how coverage evolves across Medicare and remaining commercial plans.
Key Terms
group purchasing organization financial
gpo financial
fibromyalgia medical
sublingual medical
food and drug administration regulatory
fda regulatory
medicaid regulatory
medicare regulatory
AI-generated analysis. Not financial advice.
Agreement with second leading group purchasing organization (GPO), effective June 1, 2026, provides access to approximately 17 million additional U.S. commercial lives (
Total commercial coverage between two leading GPOs now approximately 52 million lives (
TONMYA® is the first new fibromyalgia medicine for adults in over 15 years approved by the U.S. Food and Drug Administration (FDA)
BERKELEY HEIGHTS, N.J., June 08, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully-integrated, commercial-stage biotechnology company, today announced an agreement, effective June 1, 2026, with a second leading group purchasing organization (GPO) that provides coverage for TONMYA® (cyclobenzaprine HCl sublingual tablets) to an additional approximately 17 million U.S. commercial lives, representing approximately
“TONMYA’s coverage by two leading GPOs is an important milestone in expanding patient access in the early phase of our commercial launch,” said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “Existing treatments are limited by tolerability and side effects. TONMYA is a first-in-class, non-opioid analgesic designed for daily bedtime administration and long-term use. We are dedicated to increasing coverage across commercial and government channels as we work to deliver TONMYA to the more than 10 million adults in the U.S. suffering from fibromyalgia.”
The Company announced the first commercial coverage agreement on May 6, 2026, with an effective date of May 1, 2026, that provides access to approximately 35 million U.S. commercial lives (
TONMYA is now available in most states under Medicaid representing in total approximately 75 million lives. Discussions with Medicare continue to advance.
The TONMYA Together Support Program offers a savings program to eligible, commercially insured patients through local pharmacies and through a digital pharmacy service. Terms and conditions apply, subject to change. Learn more at https://www.tonmya.com/savings.
About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts more than 10 million adults in the U.S., predominantly in women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products.
About TONMYA® (cyclobenzaprine HCl sublingual tablets)
TONMYA (cyclobenzaprine HCl sublingual tablets) is a sublingual tablet formulation of cyclobenzaprine hydrochloride that was approved on August 15, 2025, by the FDA for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. TONMYA provides rapid transmucosal absorption of cyclobenzaprine and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypassing first-pass hepatic metabolism. TONMYA is a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. TONMYA was investigated as TNX-102 SL. TNX-102 SL is also being developed to treat acute stress disorder (ASD)/acute stress reaction (ASR), and major depressive disorder (MDD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TONMYA composition. These patents are expected to provide TONMYA with U.S. market exclusivity until 2034.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com.
*Tonix’s product development candidates, including TONMYA for unapproved indications, are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Contacts
Deborah Elson (Investors/Media)
Tonix Pharmaceuticals
deborah.elson@tonixpharma.com
investor.relations@tonixpharma.com
Brian Korb (Investors)
astr partners
(917) 653-5122
brian.korb@astrpartners.com
Ray Jordan (Media)
Putnam Insights
ray@putnaminsights.com
INDICATION
TONMYA is indicated for the treatment of fibromyalgia in adults.
CONTRAINDICATIONS
TONMYA is contraindicated:
In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.
During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.
WARNINGS AND PRECAUTIONS
Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.
Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.
Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.
CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥
DRUG INTERACTIONS
MAO inhibitors: Life-threatening interactions may occur.
Other serotonergic drugs: Serotonin syndrome has been reported.
CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.
Tramadol: Seizure risk may be enhanced.
Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).
Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.
Pediatric use: The safety and effectiveness of TONMYA have not been established.
Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.
Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.
Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
