Tonix Pharmaceuticals Presented Post Hoc Analyses of Phase 3 Data on TONMYATM at the 8th International Congress on Controversies in Fibromyalgia

Rhea-AI Summary

Tonix Pharmaceuticals (Nasdaq: TNXP) reported post hoc Phase 3 analyses of TONMYA (cyclobenzaprine HCl sublingual tablets) presented March 9–10, 2026. Key findings include rapid pain relief as early as Day 2, Week 14 primary endpoint superiority (LS mean diff -0.65, p<0.001), and favorable pooled benefit-risk metrics (NNT 7; NNH 26; LHH 3.7).

The company noted TONMYA was generally well tolerated; oral cavity reactions were the most common adverse events.

Positive

• FDA-approved launch in November 2025 for fibromyalgia (first approval in >15 years)
• Rapid pain relief observed as early as Day 2 in RESILIENT
• Primary endpoint met: LS mean difference -0.65, p<0.001 at Week 14
• NNT 7 for ≥30% pain reduction at Week 14 (95% CI 5–12)
• LHH 3.7, indicating nearly four-fold greater likelihood of benefit versus AE-related discontinuation

Negative

• Higher discontinuation for TONMYA: 6.1% versus 3.5% for placebo
• Common treatment-emergent adverse events were oral cavity reactions, including oral hypoesthesia 23.8% and abnormal taste 11.7%
• NNH 26 for discontinuation due to adverse events (95% CI 14–110) indicates nontrivial risk of treatment cessation

News Market Reaction – TNXP

+1.65%

1 alert

+1.65% News Effect

On the day this news was published, TNXP gained 1.65%, reflecting a mild positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

RESILIENT sample size: 457 adults Primary endpoint p-value: p<0.001 Pain score difference: -0.65 +5 more

8 metrics

RESILIENT sample size 457 adults Phase 3 fibromyalgia trial duration 14 weeks

Primary endpoint p-value p<0.001 Change in NRS pain from baseline to Week 14 vs placebo

Pain score difference -0.65 Least-squares mean treatment difference at Week 14 vs placebo

AE discontinuations 6.1% Participants discontinuing TONMYA due to adverse events

Oral hypoesthesia rate 23.8% Most common treatment-emergent adverse event in RESILIENT

Pooled analysis size 959 participants RELIEF and RESILIENT Phase 3 pooled dataset

Number needed to treat 7 ≥30% pain reduction over placebo at Week 14 (95% CI: 5–12)

Likelihood helped vs harmed 3.7 LHH based on NNT and NNH for TONMYA pooled analysis

Market Reality Check

Price: $13.24 Vol: Volume 308,581 is at 0.96...

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$13.24 Last Close

Volume Volume 308,581 is at 0.96x the 20-day average of 321,825, showing typical trading activity. normal

Technical Shares at $13.94 trade 80.08% below the $69.97 52-week high and 12.87% above the $12.35 52-week low, remaining below the $26.16 200-day MA.

Peers on Argus

While TNXP is up 3.64%, momentum data show mixed biotech moves: ANNX down 1.07%,...

1 Up 2 Down

While TNXP is up 3.64%, momentum data show mixed biotech moves: ANNX down 1.07%, MREO down 5.23%, NGNE up 4.53%. Scanner notes broader sector dynamics despite divergent single-stock directions.

Previous Clinical trial Reports

5 past events · Latest: Jan 30 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 30	Phase 3 data update	Positive	-5.4%	Positive Phase 3 RESILIENT pain and symptom data for TONMYA in fibromyalgia.
Dec 29	Program update	Positive	+0.1%	Updates on Phase 2/3-ready TNX-4800 monoclonal antibody for Lyme disease prevention.
Nov 24	IND clearance	Positive	-11.3%	FDA IND clearance for Phase 2 HORIZON study of TNX-102 SL in major depressive disorder.
Sep 29	Trial initiation plan	Positive	+2.3%	Plans to start Phase 2 trial of TNX-2900 for Prader-Willi Syndrome in 2026.
Sep 17	Asset in-licensing	Positive	+2.2%	In-licensing of TNX-4800 monoclonal antibody for seasonal Lyme disease prevention.

Pattern Detected

Clinical and development updates have produced mixed reactions, with an average move of -2.42% across 5 clinical-trial-tagged events, including several negative reactions to otherwise constructive data.

Recent Company History

Over the past several months, Tonix has repeatedly highlighted clinical progress across its pipeline. For TONMYA, positive Phase 3 RESILIENT data were presented on Jan 30, 2026 with a -5.38% next-day move. Earlier, the company advanced TNX-4800 Lyme disease prevention programs and TNX-2900 for Prader-Willi Syndrome, and secured an IND for TNX-102 SL in major depressive disorder. Historically, clinical trial communications have yielded both gains and declines, so today’s fibromyalgia-focused Phase 3 post hoc analyses arrive against a backdrop of inconsistent market responses.

Historical Comparison

-2.4% avg move · Over 5 prior clinical-trial-tagged releases, TNXP moved on average -2.42%. Today’s +3.64% reaction t...

clinical trial

-2.4%

Average Historical Move clinical trial

Over 5 prior clinical-trial-tagged releases, TNXP moved on average -2.42%. Today’s +3.64% reaction to new Phase 3 TONMYA analyses is stronger and directionally opposite that pattern.

Clinical news has progressed from TONMYA’s RESILIENT Phase 3 data to broader pipeline steps in TNX-4800 and TNX-2900, alongside IND clearance for TNX-102 SL in major depressive disorder.

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, with at least one usage via a 424B5 prospectus on 2025-11-21. While no shelf capacity details are provided here, the structure gives Tonix flexibility to raise capital as needed.

Market Pulse Summary

This announcement details post hoc Phase 3 analyses for TONMYA in fibromyalgia, with rapid pain reli...

Analysis

This announcement details post hoc Phase 3 analyses for TONMYA in fibromyalgia, with rapid pain relief, statistically significant primary and secondary endpoints, and a favorable benefit-risk profile highlighted by an NNT of 7 and LHH of 3.7. It builds on prior RESILIENT data and the drug’s recent U.S. approval. Historically, Tonix’s clinical-trial news has produced mixed stock moves, so investors may watch future prescription trends, additional safety updates, and upcoming pipeline milestones for confirmation of this efficacy signal.

Key Terms

phase 3, post hoc analysis, mixed-model repeated-measures, numeric rating scale, +4 more

8 terms

phase 3 medical

"In the RESILIENT trial, a 14-week, randomized, placebo-controlled Phase 3 study evaluating"

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.

post hoc analysis technical

"In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief"

Post hoc analysis is an exploratory look at data carried out after a study or trial is finished to search for patterns or effects that were not specified beforehand. Because it’s done after seeing the results, findings can arise by chance and are less reliable than preplanned tests; investors should treat post hoc claims as hypothesis-generating signals that may need confirmatory studies or regulatory review before they meaningfully affect a company’s value.

mixed-model repeated-measures technical

"a post hoc mixed-model repeated-measures analysis demonstrated that TONMYA produced"

A mixed-model repeated-measures (MMRM) is a statistical method used to analyze measurements taken from the same subjects multiple times, such as patient test results over several clinic visits. It handles different numbers of observations per person and natural differences between individuals, like comparing each person to their own baseline rather than only group averages. Investors care because MMRM can produce more reliable estimates of a treatment’s effect and better handle missing or uneven data, influencing how convincing clinical results look to regulators and the market.

numeric rating scale medical

"change from baseline to Week 14 in weekly average 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.

treatment-emergent adverse events medical

"The most common treatment-emergent adverse events were oral cavity reactions"

Events or symptoms that either appear for the first time or get worse after a patient starts a treatment; think of new or intensified side effects that show up once medicine or a medical device is used. Investors watch these closely because they affect whether a therapy can gain regulatory approval, be prescribed widely, or face legal and commercial setbacks—similar to how early customer complaints can sink a new product’s prospects.

number needed to treat technical

"benefit-risk profile of TONMYA using number needed to treat (NNT), number needed to harm"

Number needed to treat (NNT) measures how many patients must receive a therapy for one person to benefit compared with a control. Think of it like how many umbrellas you’d need to hand out so that one person avoids getting wet; a lower NNT means the treatment helps more people and is generally more valuable. Investors use NNT to judge a drug’s practical effectiveness and market potential relative to competitors.

number needed to harm technical

"benefit-risk profile of TONMYA using number needed to treat (NNT), number needed to harm"

Number needed to harm (NNH) is the average number of people who must receive a treatment before one additional person experiences a harmful side effect compared with a control group. Investors use NNH to gauge a drug or medical product's safety profile—like knowing how many times you can press a button before one light fails—because a low NNH signals higher safety risk that can affect regulatory approval, market acceptance, liability and long-term value.

95% confidence interval technical

"NNT for achieving a clinically meaningful ≥30% pain reduction ... was 7 (95% confidence interval (CI): 5–12)"

A 95% confidence interval is a range around a measured number that is expected to contain the true value about 95 times out of 100 if the same measurement were repeated many times. Think of it like a weather forecast that gives a band of likely temperatures rather than a single number: the wider the band, the less precise the estimate. Investors use it to judge how much uncertainty surrounds reported figures or forecasts and to compare the reliability of different estimates.

AI-generated analysis. Not financial advice.

Company launched TONMYA, approved by the FDA as a treatment for fibromyalgia, in November 2025

In post hoc analysis of the pivotal RESILIENT study, TONMYA produced rapid pain relief as early as Day 2 of treatment, with durable pain reduction and significant improvements in all key secondary endpoints as compared to placebo

In pooled post hoc analysis of the pivotal RELIEF and RELISIENT studies, TONMYA showed favorable benefit-risk profile using number needed to treat, number needed to harm, and likelihood to be helped or harmed

BERKELEY HEIGHTS, N.J., March 10, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced two oral presentations on TONMYA^TM, which was investigated as TNX-102 SL (cyclobenzaprine HCl sublingual tablets) at the 8^th International Congress on Controversies in Fibromyalgia held on March 9-10, 2026, in Krakow, Poland.

“Phase 3 post hoc analyses reinforce the potential of TONMYA to provide a benefit to the approximately 10 million adults in the U.S. living with fibromyalgia,” said Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “In a post hoc analysis of RESILIENT, the data show rapid and early onset of pain relief. In a post hoc analysis of two pivotal studies, TONMYA showed a favorable benefit-risk profile that suggests treatment benefit is nearly four times more likely than discontinuation of treatment due to an adverse event. Together, these findings underscore TONMYA’s profile as a differentiated, generally well tolerated, and effective medicine that may address the unmet medical needs of those with fibromyalgia. TONMYA is the first medication approved for fibromyalgia in over 15 years.”

Oral Presentation One: “Cyclobenzaprine HCl Sublingual Tablets (CBP SL) Provide Rapid Pain Relief in Adults with Fibromyalgia”

In the RESILIENT trial, a 14-week, randomized, placebo-controlled Phase 3 study evaluating 457 adults with fibromyalgia as defined by 2016 American College of Rheumatology (ACR) criteria, a post hoc mixed-model repeated-measures analysis demonstrated that TONMYA produced a rapid reduction in pain, with improvements versus placebo observed as early as Day 2 of treatment and statistically significant pain relief at each week over Weeks 1–14. The primary endpoint, change from baseline to Week 14 in weekly average daily numeric rating scale (NRS) pain scores, was met with high statistical significance (p<0.001), with a least-squares mean treatment difference of -0.65. All key secondary endpoints were also statistically significant in favor of TONMYA.

TONMYA was generally well tolerated, with 6.1% of participants discontinuing due to adverse events versus 3.5% with placebo. The most common treatment-emergent adverse events were oral cavity reactions, including oral hypoesthesia (23.8%) and abnormal product taste (11.7%), which were typically mild, transient, and self-limited.

Oral Presentation Two: “Cyclobenzaprine HCl Sublingual Tablets for the Treatment of Fibromyalgia: Number Needed to Treat and Number Needed to Harm”

The data from a pooled post hoc analysis of 959 participants (783 completed the studies) from the RELIEF and RESILIENT Phase 3 trials was utilized to further clarify the benefit-risk profile of TONMYA using number needed to treat (NNT), number needed to harm (NNH), and likelihood to be helped or harmed (LHH). The NNT for achieving a clinically meaningful ≥30% pain reduction over placebo at Week 14 was 7 (95% confidence interval (CI): 5–12) while the NNH for discontinuation due to an adverse event was 26 (95% CI: 14–110). Based on these values, the LHH was 3.7, indicating that TONMYA provides a nearly four-fold greater likelihood of clinical benefit than adverse event-related discontinuation.

The pooled safety data were consistent with the known profile of TONMYA, with no new or unexpected safety signals. The most common treatment-emergent adverse events were oral cavity reactions that were typically mild, transient, and self-limited.

Copies of the Company’s presentations are available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.

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-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 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 2.8mg), 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.

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@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.

FAQ

What did Tonix (TNXP) report about TONMYA pain relief timing in March 2026 presentations?

TONMYA showed rapid pain relief, with improvements versus placebo observed as early as Day 2. According to the company, RESILIENT post hoc analyses demonstrated statistically significant pain reduction across Weeks 1–14, supporting an early onset of clinical effect.

What were the Week 14 efficacy results for TONMYA in the RESILIENT trial (TNXP)?

The Week 14 primary endpoint favored TONMYA with a least-squares mean difference of -0.65 (p<0.001). According to the company, all key secondary endpoints were also statistically significant versus placebo in RESILIENT.

How do the pooled benefit-risk metrics (NNT/NNH/LHH) for TONMYA affect TNXP investors?

Pooled analysis reported an NNT of 7 and an NNH of 26, yielding an LHH of 3.7 favoring benefit over harm. According to the company, this suggests treatment benefit is nearly four times more likely than discontinuation due to adverse events.

What safety signals did Tonix (TNXP) disclose for TONMYA at the March 2026 congress?

No new or unexpected safety signals were reported; common adverse events were oral cavity reactions. According to the company, oral hypoesthesia occurred in 23.8% and abnormal product taste in 11.7%, typically mild and transient.

When did Tonix (TNXP) launch TONMYA and why is that significant for fibromyalgia patients?

Tonix launched TONMYA in November 2025, the first fibromyalgia approval in over 15 years. According to the company, the approval addresses an estimated U.S. population of about 10 million adults with fibromyalgia and unmet treatment needs.