Tonix Pharmaceuticals Presented Data on TONMYATM in Treating Patients with Fibromyalgia at the 2026 AAPM PainConnect Annual Meeting

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) presented Phase 3 data for TONMYA (cyclobenzaprine HCl sublingual tablets) at the 2026 AAPM PainConnect Annual Meeting. The 14-week RESILIENT trial (n=457) showed statistically significant mean daily pain reduction and higher 30% responder rates versus placebo. TONMYA received FDA approval in August 2025 and launched commercially in November 2025. The drug was generally well tolerated; most adverse events were mild, self-limited oral cavity reactions that rarely caused withdrawal.

Positive

• Phase 3 RESILIENT trial (n=457) showed statistically significant pain reduction
• Higher number of patients achieved a clinically meaningful 30% pain reduction versus placebo
• FDA approval in August 2025 enabled commercial launch in November 2025
• First approved fibromyalgia therapy in over 15 years, providing a non-opioid bedtime option

Negative

• Most common adverse events were oral cavity reactions that uncommonly caused study withdrawal
• Company notes oral swallowed cyclobenzaprine previously failed due to only short-term (one month) benefit

Key Figures

Phase 3 trial duration: 14 weeks Trial participants: 457 patients Clinically meaningful response: 30% reduction in daily pain +5 more

8 metrics

Phase 3 trial duration 14 weeks RESILIENT randomized, double-blind, placebo-controlled study

Trial participants 457 patients RESILIENT Phase 3 fibromyalgia study

Clinically meaningful response 30% reduction in daily pain Threshold for clinically meaningful pain response vs placebo

Therapy gap Over 15 years First approved fibromyalgia therapy in more than 15 years

Short-term oral benefit One month Oral cyclobenzaprine reported to provide only short-term benefit

ACR criteria year 2016 American College of Rheumatology diagnostic criteria for fibromyalgia

FDA approval date August 2025 TONMYA approval for fibromyalgia in adults

Commercial launch November 2025 U.S. commercial launch of TONMYA

Market Reality Check

Price: $13.94 Vol: Volume 308,581 is broadly...

normal vol

$13.94 Last Close

Volume Volume 308,581 is broadly in line with 20-day average 321,398 (no clear volume reaction). normal

Technical Shares at 13.94, trading below 200-day MA of 26.24, reflecting a longer-term downtrend pre-announcement.

Peers on Argus

TNXP was down 1.97% while peers like CADL and OMER in the same biotech group app...

2 Up

TNXP was down 1.97% while peers like CADL and OMER in the same biotech group appeared in momentum scans with upward moves, suggesting today’s action was more stock-specific than sector-driven.

Common Catalyst At least one peer (CADL) also highlighted new Phase 3 data at a medical meeting, pointing to a broader backdrop of clinical data presentations in biotech.

Historical Context

5 past events · Latest: Mar 03 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Mar 03	Conference poster	Positive	+0.3%	Announcement of upcoming TONMYA poster at AAPM PainConnect meeting.
Mar 03	Exchange uplisting	Positive	-0.3%	Transfer of listing to Nasdaq Global Select Market for higher-tier status.
Feb 25	Investor conferences	Positive	+3.9%	Participation in March investor conferences highlighting TONMYA and pipeline.
Jan 30	Phase 3 data	Positive	-5.4%	Presentation of positive Phase 3 RESILIENT data for TONMYA at summit.
Jan 06	Investor conferences	Positive	+0.9%	January conferences featuring TONMYA, migraine products, and pipeline overview.

Pattern Detected

Recent news, often positive (data presentations, conferences, uplisting), has produced mixed price reactions, with both gains and selloffs on ostensibly favorable updates.

Recent Company History

Over the past few months, Tonix has repeatedly highlighted TONMYA and its broader CNS pipeline through conference presentations and investor events. Positive Phase 3 RESILIENT data were showcased on Jan 30, 2026, while multiple conference announcements in Jan–Mar 2026 emphasized commercialization of TONMYA and investor outreach. The uplisting to the Nasdaq Global Select Market on Mar 3, 2026 underscored governance and listing strength. Today’s detailed fibromyalgia data presentation builds directly on these earlier RESILIENT results and ongoing visibility efforts.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-09-04

The company has an active S-3/A shelf registration filed on 2025-09-04, currently noted as not effective, with at least one usage via a 424B5 filing on 2025-11-21. This framework provides a mechanism for future registered offerings if and when effective, but no specific capacity details are available here.

Market Pulse Summary

This announcement reinforced TONMYA’s clinical profile, highlighting statistically significant pain ...

Analysis

This announcement reinforced TONMYA’s clinical profile, highlighting statistically significant pain reduction in a 14-week, 457-patient Phase 3 study and a clinically meaningful 30% pain response threshold. It also underscored TONMYA’s differentiated sublingual, non-opioid mechanism and its role as the first approved fibromyalgia therapy in over 15 years. Investors may track launch progress since November 2025, further clinical publications, and regulatory or financing developments when assessing TNXP’s risk–reward.

Key Terms

sublingual, metabolite, Phase 3, randomized, double-blind, placebo-controlled, +1 more

5 terms

sublingual medical

"TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia"

Sublingual describes a way to take a drug or supplement by placing it under the tongue so active ingredients are absorbed through the thin tissue there directly into the bloodstream. Like taking a shortcut compared with swallowing a pill, this can produce faster effects, simpler dosing and sometimes more predictable delivery. Investors watch for sublingual formulations because they can affect a product’s market appeal, regulatory pathway, pricing and competitive positioning.

metabolite medical

"reduced formation of the active, persistent metabolite norcyclobenzaprine"

A metabolite is a chemical produced when the body or a drug is broken down or used by cells — think of it as the crumbs left after digesting a meal. For investors, metabolites matter because they can be harmless, active (helping or changing a drug’s effect), or harmful, and their behavior drives safety tests, regulatory decisions, patent scope and a drug’s commercial prospects.

Phase 3 medical

"statistically significant pain reduction in two Phase 3 trials and was generally well tolerated"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

randomized, double-blind, placebo-controlled medical

"a 14-week randomized, double-blind, placebo-controlled study that assessed the safety"

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

Food and Drug Administration regulatory

"TONMYA was approved by the FDA in August 2025 in part based on the Phase 3"

A government agency that reviews and regulates medicines, medical devices, food safety, and related products to ensure they are safe and effective for public use. Investors watch its actions like a referee’s calls: approvals, warnings, inspections or recalls can directly affect a product’s ability to reach the market, a company’s sales and costs, and overall business risk and valuation.

AI-generated analysis. Not financial advice.

TONMYA (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults, was commercially launched in November 2025

Treatment with TONMYA provided statistically significant pain reduction in two Phase 3 trials and was generally well tolerated

BERKELEY HEIGHTS, N.J., March 09, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, presented data on TONMYA^TM (cyclobenzaprine HCl sublingual tablets), at the 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, in Salt Lake City, Utah.

“The data presented at the AAPM PainConnect Annual Meeting support TONMYA’s role as a safe and effective non-opioid analgesic for daily use at bedtime in fibromyalgia,^1,2” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TONMYA is designed to target nonrestorative sleep and is a first-in-class tertiary amine tricyclic for long-term use. As the first approved therapy for fibromyalgia in over 15 years, TONMYA is an alternative to three currently FDA-approved medicines, which are limited by side effects, adherence, and high discontinuation rates. TONMYA’s unique sublingual formulation enables cyclobenzaprine to bypass first-pass hepatic metabolism. Relative to off-label oral swallowed cyclobenzaprine, TONMYA treatment results in reduced formation of the active, persistent metabolite norcyclobenzaprine, which we believe interferes with the durability of cyclobenzaprine’s treatment effect in fibromyalgia with long term dosing. Oral cyclobenzaprine failed in development because it provided only short-term (one month) benefit³, which is not sufficient for the treatment of fibromyalgia, a chronic condition that requires a sustained treatment effect.”

Data presented at the AAPM PainConnect Annual Meeting are from the Phase 3 RESILIENT trial, a 14-week randomized, double-blind, placebo-controlled study that assessed the safety and efficacy of TONMYA in 457 patients who met the 2016 American College of Rheumatology (ACR) diagnostic criteria for fibromyalgia. In addition to showing a statistically significant reduction in mean daily pain at 14 weeks, TONMYA treatment resulted in an increase over placebo in the number of individuals with a 30% reduction in daily pain, which is considered a clinically meaningful response. The most common adverse events were mild and self-limited oral cavity reactions that uncommonly led to study withdrawal. TONMYA was approved by the FDA in August 2025 in part based on the Phase 3 RESILIENT trial results and was commercially launched in the U.S. in November 2025.

A copy of the Company’s poster presentation, “Treatment with TNX-102 SL Produces Clinically Meaningful Improvements in Patient-Centered Outcomes in Fibromyalgia,” is available under the Presentations tab of the Tonix website at https://ir.tonixpharma.com/presentations.

Citations

¹Carette S, et al. Arthritis Rheum. 1994. 37(1):32-40. doi: 10.1002/art.1780370106.
²Lederman S, et al. Arthritis Care Res (Hoboken). 2023. 75(11):2359-2368. doi: 10.1002/acr.25142.
³Lederman S, et al. Pain Med. 2026. 27(1):86-94. doi: 10.1093/pm/pnaf089.

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 an estimated 6-12 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-HT_2A 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 reaction (ASR)/acute stress disorder (ASD), 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.

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^TM (cyclobenzaprine HCl sublingual tablets 2.8 mg), the Company’s recently approved flagship 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® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X.

*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.

Tonmya, Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines.

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. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 18, 2025, 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@tonixpharma.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.

FAQ

What did Tonix (TNXP) present about TONMYA at the March 9, 2026 AAPM meeting?

Tonix presented Phase 3 RESILIENT data showing statistically significant mean daily pain reduction at 14 weeks. According to the company, the 14-week randomized trial (n=457) also increased the number of patients with a clinically meaningful 30% pain reduction versus placebo.

When was TONMYA (TNXP) approved and commercially launched in the U.S.?

TONMYA received FDA approval in August 2025 and launched commercially in November 2025. According to the company, approval was based in part on RESILIENT trial results supporting safety and efficacy for fibromyalgia.

How effective was TONMYA in the RESILIENT Phase 3 trial (TNXP)?

TONMYA produced a statistically significant reduction in mean daily pain and more 30% responders at 14 weeks versus placebo. According to the company, a 30% pain reduction is considered a clinically meaningful response for patients.

What side effects were reported with TONMYA in the Phase 3 study?

The most common adverse events were mild, self-limited oral cavity reactions that rarely led to withdrawal. According to the company, overall tolerability was acceptable for long-term bedtime use in fibromyalgia.

How does TONMYA differ from oral cyclobenzaprine for fibromyalgia (TNXP)?

TONMYA’s sublingual formulation is designed to bypass first-pass metabolism and reduce norcyclobenzaprine formation. According to the company, this may improve durability of effect compared with off-label swallowed oral cyclobenzaprine, which previously showed only short-term benefit.