Tonix Pharmaceuticals Presented an Analysis of Phase 3 Data Demonstrating TONMYA® Improved Physical Symptoms and Functional Ability of Patients with Fibromyalgia at the IASP 2026 World Congress on Pain

RELIEF’s symptom and function results were nominally significant because of the hierarchy used to control false-positive findings.

Rhea-AI Summary

Tonix Pharmaceuticals (TNXP) presented Phase 3 analyses showing TONMYA improved physical symptoms and functional ability versus placebo in adults with fibromyalgia. The RELIEF and RESILIENT findings were presented at the IASP 2026 World Congress on Pain in Bangkok.

Both trials showed statistically and clinically significant improvements in the primary pain endpoint at Week 14. Scores on the Fibromyalgia Impact Questionnaire-Revised, which measures symptoms and daily functioning, improved more with TONMYA than placebo at Weeks 2, 6, 10 and 14. Week 14 results for both domains were statistically significant in RESILIENT (p≤0.001) but only nominally significant in RELIEF (p<0.01) because of the endpoint testing hierarchy.

No new safety signals were observed; the most common treatment-emergent adverse events were local oral administration site reactions. TONMYA was commercially launched in November 2025.

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Positive

• Major pointWeek 14 pain scores improved statistically and clinically significantly versus placebo in both Phase 3 trials.
• Moderate pointSymptoms and function scores improved more versus placebo at Weeks 2, 6, 10 and 14 in both trials.
• Minor pointRESILIENT Week 14 results reached statistical significance for both symptom and function domains (p≤0.001).
• Minor pointNo new safety signals were observed; the adverse-event profile was consistent with previous studies.

Negative

• Minor pointRELIEF Week 14 symptom and function results were only nominally significant (p<0.01) under hierarchical endpoint testing.
• Minor pointLocal oral administration site reactions were the most common treatment-emergent adverse events.

Key Figures

RESILIENT FIQR domain p-value: p≤0.001 RELIEF FIQR domain p-value: p<0.01 Assessment period: 14 weeks

RESILIENT FIQR domain p-value

p≤0.001

Week 14; Symptoms and Function domains

RELIEF FIQR domain p-value

p<0.01

Week 14; nominal significance for Symptoms and Function domains

Assessment period

14 weeks

Phase 3 RELIEF and RESILIENT studies

Key Terms

placebo-controlled, numeric rating scale, adverse event, serotonin syndrome, +1 more

5 terms

placebo-controlled medical

"randomized, double-blind, placebo-controlled Phase 3 trials"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

numeric rating scale medical

"daily numeric rating scale (NRS) pain scores"

A numeric rating scale is a simple system that converts opinions or measurements into numbers so different items can be compared and tracked over time. For investors, it turns qualitative judgments—like analyst recommendations, credit risk, or clinical outcomes—into a clear score you can sort, average, or watch for changes, much like using a thermometer or star rating to quickly judge and compare options when making decisions.

adverse event medical

"an adverse event (AE) profile consistent with previous studies"

An adverse event is any unwanted or harmful medical occurrence experienced by a person during a clinical trial or after using a product, whether or not it is caused by the treatment. Investors watch these reports because they can signal safety problems that delay approvals, trigger additional testing, reduce sales, or harm a company’s reputation — similar to how a series of car breakdowns can cut value and future sales for an automaker.

serotonin syndrome medical

"increases the risk of serotonin syndrome"

A potentially serious medical condition caused by excess serotonin activity in the nervous system, usually from certain medications or drug interactions; symptoms range from mild agitation, tremor and rapid heart rate to severe high fever, muscle rigidity, seizures or loss of consciousness. It matters to investors because occurrences, clinical-trial signals, or regulatory findings about serotonin syndrome can affect a drug’s safety profile, labeling, approval prospects and commercial marketability—similar to a product recall or defect report for a consumer good.

monoamine oxidase inhibitors medical

"concomitant use of monoamine oxidase (MAO) inhibitors"

Monoamine oxidase inhibitors (MAOIs) are a class of medicines that block an enzyme that breaks down certain brain chemicals involved in mood and behavior; think of the enzyme as a garbage collector and MAOIs as a temporary lock on the dumpster so those chemicals stay available longer. They matter to investors because their effectiveness, safety profile, dietary and drug interaction risks, and regulatory status can strongly affect a drug’s market potential, pricing, and liability exposure.

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TONMYA improved Fibromyalgia Impact Questionnaire-Revised (FIQR) symptoms and function scores versus placebo in both domains at Week 14 in RELIEF and RESILIENT Phase 3 pivotal studies

Tonix commercially launched TONMYA^® in November 2025, the first fibromyalgia drug for adults in the U.S. in over 15 years approved by the U.S. Food and Drug Administration (FDA)

BERKELEY HEIGHTS, N.J., Oct. 27, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biopharmaceutical company, presented data from an analysis of the Phase 3 RELIEF and RESILIENT studies of TONMYA^® (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults demonstrating outcomes as measured by the Fibromyalgia Impact Questionnaire-Revised (FIQR) at the International Association for the Study of Pain (IASP) 2026 World Congress on Pain, held October 26-30, 2026, in Bangkok, Thailand.

“TONMYA improved a broad spectrum of physical symptoms and functional capacity in adults with fibromyalgia in two Phase 3 studies,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The core physical symptoms of fibromyalgia can be debilitating for patients with fibromyalgia, interfering with their quality of life. We believe the data reinforce the role of TONMYA as a first-line, non-opioid treatment option that can help patients function better in their daily lives.”

RELIEF and RESILIENT were randomized, double-blind, placebo-controlled Phase 3 trials that assessed the efficacy and safety of TONMYA versus placebo over 14 weeks in adults with fibromyalgia who were diagnosed with the condition diagnosed according to the 2016 American College of Rheumatology (ACR) diagnostic criteria. In both trials, participants were randomized 1:1 to receive either TONMYA (2.8 mg tablets at bedtime for two weeks, followed by 5.6 mg at bedtime through Week 14) or matching placebo for 14 weeks.

RELIEF and RESILIENT evaluated the same primary efficacy and key secondary efficacy endpoints. The primary efficacy endpoint was the change from baseline in the weekly average of daily self-reported numeric rating scale (NRS) pain scores (0-10) at Week 14. There were multiple key secondary efficacy endpoints, including change from baseline in the FIQR Symptoms domain score and change from baseline in the FIQR Function domain score. The FIQR assesses overall fibromyalgia burden and severity over the prior seven days, including physical functioning and symptoms. FIQR assessments were conducted at Weeks 2, 6, 10, and 14, with Week 14 as the pre-specified timepoint of interest.

In the RELIEF and RESILIENT studies, TONMYA provided statistically and clinically significant improvements over placebo in the change from baseline in the weekly average of daily numeric rating scale pain scores versus placebo at Week 14. A greater reduction from baseline in both the FIQR Symptoms and FIQR Function total scores was seen in participants who received TONMYA as compared to those who received placebo at Weeks 2, 6, 10, and 14 in both studies. Week 14 was statistically significant (p≤0.001) for both domains in RESILIENT and nominally significant (due to the hierarchical testing of endpoints used to control type 1 error) in RELIEF (p<0.01). TONMYA was generally well tolerated, with an adverse event (AE) profile consistent with previous studies; no new safety signals were observed. The most common treatment-emergent adverse events (TEAEs) were local oral administration site reactions.

A copy of the Company’s poster presentation, “Cyclobenzaprine HCl Sublingual Reduces Fibromyalgia Impact on Physical Symptoms & Functional Ability,” is available under the Scientific Presentations tab on the Tonix website at https://www.tonixpharma.com/scientific-presentations/.

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 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 biopharmaceutical company focused on central nervous system (CNS) disorders, infectious diseases, and immunology conditions with high unmet medical needs. TONMYA^® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first 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 the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including Phase 2-ready 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, TNX-1500 (anti-CD40L mAb) is a Phase 2-ready, third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates, including TNX-102 SL for new, 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. 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

Deborah Elson
Tonix Pharmaceuticals
deborah.elson@tonixpharma.com
investor.relations@tonixpharma.com

Brian Korb
astr partners
(917) 653-5122
brian.korb@astrpartners.com

Media Contacts

Andrea Cohen
Sam Brown Inc.
(917) 209-7163
andreacohen@sambrown.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.

FAQ

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What did Tonix’s TONMYA Phase 3 analysis show for fibromyalgia symptoms and function?

TONMYA produced greater improvements than placebo in symptom and function scores at Weeks 2, 6, 10 and 14 in RELIEF and RESILIENT. At Week 14, both domains were statistically significant in RESILIENT (p≤0.001) and nominally significant in RELIEF (p<0.01) because of hierarchical endpoint testing.

How were Tonix’s RELIEF and RESILIENT trials of TONMYA designed?

RELIEF and RESILIENT were randomized, double-blind, placebo-controlled trials lasting 14 weeks in adults with fibromyalgia. Participants were assigned 1:1 to TONMYA or matching placebo. TONMYA dosing was 2.8 mg at bedtime for two weeks, followed by 5.6 mg at bedtime through Week 14.