Tonix (NASDAQ: TNXP) secures TONMYA fibromyalgia coverage for 35M insured lives
Rhea-AI Filing Summary
Tonix Pharmaceuticals Holding Corp. entered into an agreement with a leading group purchasing organization, effective May 1, 2026, that provides commercial insurance coverage for TONMYA to approximately 35 million U.S. lives, about 20% of roughly 177 million commercially insured individuals.
TONMYA, a first-in-class non-opioid analgesic and the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years, is also covered under Medicaid in 38 states for approximately 55 million beneficiaries, representing 73% of roughly 75 million Medicaid lives.
Positive
- Expanded commercial access: New agreement with a leading group purchasing organization provides TONMYA coverage for approximately 35 million U.S. commercial lives, about 20% of roughly 177 million commercially insured individuals, materially increasing potential patient reach.
- Broad Medicaid footprint: TONMYA is covered under Medicaid in 38 states for about 55 million beneficiaries, representing 73% of roughly 75 million Medicaid lives, supporting access for lower-income fibromyalgia patients.
Negative
- None.
Insights
New GPO deal significantly expands TONMYA’s insured patient access.
The agreement with a leading group purchasing organization extends TONMYA coverage to approximately 35 million U.S. commercial lives, about 20% of roughly 177 million commercial lives. This directly addresses payer access, a key hurdle for newly launched specialty medicines.
Combined with Medicaid coverage for approximately 55 million lives across 38 states, representing 73% of roughly 75 million Medicaid lives, TONMYA now has broad insured reach in fibromyalgia, a condition affecting more than 10 million U.S. adults. Future company disclosures may clarify how this translates into prescription uptake and revenue.
8-K Event Classification
Key Figures
Key Terms
group purchasing organization financial
fibromyalgia medical
sublingual tablets medical
serotonin syndrome medical
central nervous system medical
market exclusivity financial
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of report (date of earliest event reported):
(Exact name of registrant as specified in its charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area
code:
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| The |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 | Regulation FD Disclosure. |
On May 6, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced it entered into an agreement with a group purchasing organization (“GPO”) that provides coverage for TONMYA®. A copy of the press release that discusses this matter is attached hereto as Exhibit 99.01.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.01 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United States Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On May 6, 2026, the Company announced it entered into an agreement with a GPO, effective May 1, 2026, that provides coverage to approximately 35 million U.S. commercially insured individuals, with standard utilization management criteria, for TONMYA. To date, TONMYA is covered under Medicaid in 38 states, representing approximately 55 million Medicaid beneficiaries.
Forward-Looking Statements
This Current Report on Form 8-K contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical trials, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the SEC. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) |
Exhibit No. |
Description. | ||
|
99.01 |
Press Release of the Company, dated May 6, 2026 | |||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| TONIX PHARMACEUTICALS HOLDING CORP. | |||
| Date: May 6, 2026 | By: | /s/ Bradley Saenger | |
| Bradley Saenger | |||
| Chief Financial Officer | |||
TONIX PHARMACEUTICALS HOLDING CORP. FORM 8-K
EXHIBIT 99.01
Tonix Pharmaceuticals Secures Commercial Payer Coverage for TONMYA®, Providing Access for ~35 Million U.S. Patients
Agreement with leading group purchasing organization (GPO) provides access to approximately 35 million U.S. commercial lives (20% of ~177 million commercial lives in the U.S.)
TONMYA (cyclobenzaprine HCl sublingual tablets), the first FDA-approved treatment for fibromyalgia in adults in more than 15 years, commercially launched in November 2025
TONMYA is a first-in-class non-opioid analgesic indicated for the treatment of fibromyalgia in adults as a daily bedtime medicine for long-term use
BERKELEY HEIGHTS, N.J., May 6, 2026--Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully integrated, commercial biotechnology company, today announced an agreement effective May 1, 2026, with a leading group purchasing organization (GPO) that provides coverage to approximately 35 million U.S. commercial lives, representing approximately 20% of the roughly 177 million commercial lives in the U.S., with standard utilization management criteria, for TONMYA® (cyclobenzaprine HCl sublingual tablets).
"This agreement is an important milestone in expanding patient access to TONMYA," said Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals. “We are encouraged by this first partnership with managed care and look forward to continuing to pursue additional coverage across commercial and government channels.”
Dr. Lederman continued, “TONMYA is a first-in-class non-opioid analgesic indicated for the treatment of fibromyalgia in adults. TONMYA is the first new FDA-approved treatment option for fibromyalgia in over 15 years. Fibromyalgia patients have experienced dissatisfaction with available therapies, with 85% of first-line treatments failing due to efficacy and tolerability issues.1,2 We are committed to providing patient access to TONMYA by continuing to engage with commercial payers on its value and offering a patient support program to help patients access their prescribed medication.”
Tonix also continues to progress discussions with Medicare and Medicaid. To date, TONMYA is covered under Medicaid in 38 states for approximately 55 million lives representing 73% of the roughly 75 million Medicaid lives.
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., approximately 90% of whom are 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 patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TONMYA 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 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 2034/2035.
Citations
1Robinson RL, et al. Pain Med. 2012 13(10):1366-76. doi: 10.1111; 85% received drug treatment.
2EVERSANA primary physician research, May 2024; commissioned by Tonix.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults 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 investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com.
*Tonix’s product development candidates 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.
Investor Contacts
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599
Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com
Media Contacts
Deborah Elson
Tonix Pharmaceuticals
deborah.elson@tonixpharmaceuticals.com
Ray Jordan
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 ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients)
were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous
ulcer.
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.