Full Press Release Details
Pharmaceuticals Secures Second Commercial Payer Agreement for TONMYA , Expanding Total Commercial Coverage to ~52 Million U.S. Lives
with second leading group purchasing organization (GPO), effective June 1, 2026, provides access to approximately 17 million additional
U.S. commercial lives (10% of the ~177 million commercial lives in the U.S.)
commercial coverage between two leading GPOs now approximately 52 million lives (29% of the total commercial lives in the U.S.)
is the first new fibromyalgia medicine for adults in over 15 years approved by the U.S. Food and Drug Administration (FDA)
HEIGHTS, N.J., June 8, 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 10% of the roughly 177 million commercial
lives in the U.S., with standard utilization management criteria. In total, TONMYA now has commercial coverage for approximately 52 million
U.S. lives, representing approximately 29% of the total commercial lives in the U.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."
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 (20% of the total commercial lives in the U.S.)
is now available in most states under Medicaid representing in total approximately 75 million lives. Discussions with Medicare continue
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.
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.
TONMYA (cyclobenzaprine HCl sublingual tablets)
(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, 1-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
Pharmaceuticals Holding Corp.
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.
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.
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.
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.
Elson (Investors/Media)
is indicated for the treatment of fibromyalgia in adults.
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.
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.
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.
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.
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.
effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and
in patients taking anticholinergic drugs.