For decades, the playbook has been simple: when war breaks out, buy gold. But the ongoing U.S.-Israeli conflict with Iran is rewriting that script in real time, and investors are scrambling to make sense of a metal that is behaving more like a speculative trade than the world’s oldest store of value.
Gold has dropped nearly 10% this week, putting it on track for its worst weekly performance in 43 years, with the metal’s total decline since the war began now sitting at approximately 13%. On Friday, gold was trading around $4,570 per troy ounce — erasing two months of gains in a matter of days.
The Rate Problem Nobody Saw Coming
The paradox at the heart of gold’s collapse is this: the same war that should theoretically be sending investors rushing into safe-haven assets is also the reason central banks are slamming the door on interest rate cuts.
The Federal Reserve held rates steady and cited uncertain impacts from the conflict, while the Bank of Japan kept rates unchanged, noting that inflation risks are now tilted to the upside. Central banks across Europe — including the U.K. and the eurozone — followed suit. Market expectations for Fed rate cuts have shifted dramatically, with traders now pricing in no cuts until as late as June 2027 — a full twelve months later than pre-war projections. That matters enormously for gold, which pays no yield. When bonds and other interest-bearing assets become more attractive, gold loses its competitive edge almost immediately.
The Dollar Is Doing Gold No Favors Either
The U.S. dollar has rebounded approximately 2.2% since the Iran war began, halting a months-long slide. Because gold is priced in dollars, a stronger greenback makes the metal relatively more expensive for international buyers, dampening global demand.
Oil prices have remained above $100 per barrel following attacks on major energy infrastructure, including one of the world’s largest natural gas fields shared by Iran and Qatar, with the conflict showing no signs of resolution. Energy-driven inflation is now feeding directly into the rate calculus that is punishing gold.
From Safe Haven to Meme Trade — and Back?
Part of what’s happening is a hangover from an extraordinary run. Gold surged 66% in 2025, its best annual performance since 1979, before hitting $5,000 per troy ounce for the first time in January 2026. Retail investors piled in chasing momentum, and when that momentum began to reverse, the selling accelerated. Some analysts have raised the possibility that central banks, which were previously aggressive buyers, may now be turning into net sellers — an additional headwind few had anticipated.
The longer-term bull case hasn’t disappeared. J.P. Morgan maintains a 2026 year-end target of $6,300 per ounce, while Deutsche Bank holds firm at $6,000 — though both forecasts were set before the Iran escalation.
For long-term holders, the fundamental case remains intact. Real interest rates, global monetary policy, and persistent geopolitical uncertainty have historically been the primary drivers of sustained gold bull markets, and none of those underlying forces have been resolved.
The question isn’t whether gold’s story is over. The question is whether the market has finally priced in a world where geopolitical chaos and monetary tightening can coexist — and where gold, at least temporarily, is caught in the crossfire.
President Trump issued a 60-day waiver of the Jones Act on Wednesday in a bid to cool surging domestic energy prices as the Iran conflict continues to hammer global oil markets. The move, confirmed by White House press secretary Karoline Leavitt, opens U.S. ports to foreign-flagged vessels for the next two months — covering crude oil, refined products like gasoline and diesel, natural gas, coal, fertilizer, and other energy-derived commodities.
The decision comes as Brent crude crossed $109 per barrel Wednesday morning — up more than 7% on the day — while WTI traded above $97. Gas prices at the pump have climbed to a national average of $3.84 per gallon, up sharply from $2.92 just one month ago, according to AAA data. Diesel has already crossed $5 per gallon nationally. The administration is clearly feeling political pressure to act ahead of the midterm cycle, and the Jones Act waiver is the most tangible move it has made so far.
What the Jones Act Actually Does
The Jones Act — formally the Merchant Marine Act of 1920 — requires that any cargo transported between U.S. ports be carried by vessels that are U.S.-built, U.S.-owned, U.S.-flagged, and U.S.-crewed. The law was designed to protect the domestic shipping industry after World War I, but has long been criticized by economists as an inflationary form of protectionism that raises the cost of moving goods within the country. With fewer than 100 Jones Act-compliant vessels in existence, the waiver immediately opens the door to a much larger pool of international tankers to move fuel between domestic ports.
The Practical Impact — And Its Limits
In theory, the waiver should have its biggest effect on refined product shipments from Gulf Coast refinery complexes to the more isolated East Coast — a corridor that has historically been a bottleneck during supply disruptions. Cheaper, more accessible shipping capacity means fuel can theoretically move faster and at lower cost to the regions that need it most.
But experts are already tempering expectations. The core problem isn’t moving fuel — it’s refining it. Most U.S. refineries are configured to process heavier Middle Eastern crude grades, while domestic shale production yields lighter oil. That structural mismatch means the U.S. still cannot fully self-supply even with more flexible shipping rules. The waiver makes domestic logistics more efficient, but it does not solve the underlying supply equation.
The Broader Policy Picture
The Jones Act move is reportedly just one item on a broader White House menu of potential energy interventions being considered, including possible Treasury-led action in energy futures markets and export bans on crude and refined products. Any of those measures — if enacted — would carry significant market implications across the energy sector.
For small and microcap investors, the read-through is layered. Domestic shippers and Jones Act operators could see near-term pricing pressure as foreign competition enters the market. Refiners with Gulf Coast exposure and East Coast distribution capability may benefit from improved logistics economics. And any company with meaningful fuel cost exposure — from regional truckers to agricultural operators to industrial manufacturers — should be watching this space closely as the administration continues to improvise policy responses to a crisis with no clear end date.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Double E Pipeline growth. Summit recently signed two new long-term take-or-pay agreements totaling 540 MMcf/d of incremental firm capacity on the Double E Pipeline, an 11-year, 210 MMcf/d contract with a large investment-grade shipper and an 11-year, 230 MMcf/d agreement with an undisclosed shipper, alongside the previously announced 100 MMcf/d Producers Midstream II commitment, which received an affirmative FID during the quarter. These contracts are expected to grow the Permian Segment Adj. EBITDA from ~$34 million in 2025 to ~$60 million by 2029.
2026 guidance. Summit expects full-year 2026 Adj. EBITDA of $225 million to $265 million, with total capital expenditures of $85 million to $105 million, including approximately $35 million attributable to Double E. The outlook assumes WTI at approximately $64 per barrel and Henry Hub at approximately $3.40 per MMBtu, both materially below current strip prices, suggesting meaningful upside if the commodity environment is sustained. The company expects 116 to 126 well connections supported by seven active rigs and approximately 90 DUCs.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200
Expect to initiate U.S. field study in 2027 for TNX-4800 for seasonal prevention of Lyme disease pending FDA clearance
Completed $20.0 million registered direct offering with Point72 on December 29, 2025
Approximately $207.6 million in cash and cash equivalents as of December 31, 2025
BERKELEY HEIGHTS, N.J., March 12, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent operational highlights.
“2025 was transformational for Tonix as we achieved FDA approval and began the U.S. commercial launch of TONMYA, our first fully in-house developed product and the first new medicine approved for fibromyalgia in more than 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for long-term, once-daily bedtime dosing. We believe TONMYA now provides an alternative medicine for the approximately 10 million adults in the U.S. who suffer from fibromyalgia. We have the capabilities to engage healthcare providers and patients, having launched the product and an approximately 90-member salesforce. Early prescription trends reflect favorable prescriber uptake and repeat utilization consistent with our internal launch expectations. Our experienced commercial team is committed to growing awareness and adoption, facilitating patient access, and obtaining payer coverage as we strive to improve the fibromyalgia journey for patients and healthcare providers.”
Dr. Lederman continued, “We also meaningfully advanced our robust clinical pipeline in 2025. Tonix in-licensed TNX-4800, a long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, for which there are no FDA-approved vaccines or prophylactics. This program, developed by researchers at UMass Chan Medical School, anchors our clinical-stage infectious disease pipeline, and we plan to discuss Phase 2/3 development with the FDA this year. An additional highlight includes FDA clearance of the Investigational New Drug application (IND) for HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in major depressive disorder, which is expected to initiate enrollment in mid-2026. Looking ahead, our priorities are clear. We are driven to continue our momentum in 2026 as we focus on the successful commercialization of TONMYA, pipeline progress, and sustainable long-term value for patients and shareholders.”
Commercial Updates
TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults
In August 2025, the U.S. FDA approved TONMYA for the treatment of fibromyalgia in adults, making it the first new prescription medicine approved for this indication in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical trials of nearly 1,000 patients that demonstrated statistically significant reduction in daily pain scores compared to placebo.
On November 17, 2025, TONMYA became commercially available at pharmacies by prescription in the U.S. Approximately 90 sales representatives were deployed in the field in advance of the launch. Early prescription trends reflect favorable adoption rates by prescribers and patients, with prescription volumes increasing each full month post launch. Launch metrics for the period November 17, 2025–February 27, 2026 (launch-to-date), are as follows:
More than 1,500 healthcare providers have prescribed TONMYA to patients.
Approximately 2,500 patients have initiated treatment with TONMYA.
Cumulative prescriptions totaled approximately 4,200. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue.
The Company has contracted with existing wholesalers and specialty pharmacies for distribution and with companies to assist with prescription fulfillment and patient access. Tonix also has a robust patient access program and support services in place, including TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization.
The Company is prioritizing expanding payer engagement and establishing contracts with commercial payers, while also progressing discussions with Medicare and Medicaid.
Infectious Disease Pipeline TNX-4800 (anti-OspA mAb): long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease, which has no FDA-approved vaccines or prophylactics
In December 2025, Tonix announced plans to meet with the FDA in 2026 to explore Phase 2/3 development options, including a Phase 2 field study and a Phase 2 controlled human infection model (CHIM) study, which is also called a human challenge study. The Company expects to have GMP investigational product available for clinical testing in early 2027. Pending FDA clearances, the field study is expected to initiate enrollment in 2027 and the CHIM study in 2028.
Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in development for major depressive disorder (MDD)
In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026.
Prior studies of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) showed promising signals for improvement of depressive symptoms. TNX-102 SL treatment has been associated with a low incidence of side effects common with traditional antidepressants, including weight gain, blood pressure changes, sexual dysfunction, and cognitive issues.
TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of PTSD
The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial is being conducted by the University of North Carolina under an investigator-initiated IND application. The OASIS trial examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026.
Immunology Pipeline TNX-1500 (dimeric Fc modified anti-CD40L, humanized monoclonal antibody): third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders
In November 2025, Tonix announced a collaboration with Massachusetts General Hospital to advance a Phase 2 open-label, investigator-initiated clinical trial of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026 pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients.
In October 2025, Tonix presented an update at the Japan Society for Transplantation annual congress, highlighting Phase 1 safety and pharmacokinetic and pharmacodynamic results and outlining next steps toward Phase 2 evaluation in allogenic kidney transplantation.
Rare Disease Pipeline TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval
In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled trial in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027.
Financial: Recent Highlights
Tonix had approximately $207.6 million of cash and cash equivalents as of December 31, 2025, compared to approximately $98.8 million as of December 31, 2024. Net cash used in operations was approximately $99.8 million for the full year ended December 31, 2025, compared to $60.9 million for the same period in 2024. Cash paid for capital expenditures for the full year ended December 31, 2025, were approximately $3.4 million compared to $0.1 million for the same period in 2024.
In December 2025, Tonix completed a $20.0 million registered direct offering with Point72 Asset Management. The net proceeds are being used to fund commercialization of marketed products, pipeline development, and general working capital. TD Cowen acted as sole placement agent for the offering. A.G.P./Alliance Global Partners acted as a financial advisor.
Subsequent to year-end, the Company has raised $8.6 million proceeds using its at-the-market (ATM) facility.
The Company believes that its cash resources at December 31, 2025, will meet its planned operating and capital expenditure requirements into the first quarter of 2027.
As of March 11, 2026, the Company had 13,405,401 shares of common stock outstanding.
Full Year 2025 Financial Results
Net product revenue for the full year 2025 was approximately $13.1 million, compared to $10.1 million in 2024. Net revenue from sales of Zembrace®, SymTouch®, and Tosymra® for the full year 2025 was approximately $11.7 million, compared to $10.1 million in 2024. Net revenue from sales of TONMYA for the period from launch on November 17, 2025, to December 31, 2025, was approximately $1.4 million. Cost of sales for the full year 2025 was approximately $6.6 million, compared to $7.8 million in 2024.
Research and development expenses for the full year 2025 were approximately $44.5 million, compared to $40.0 million in 2024. This increase is predominately due to pipeline prioritization period over period, and increased headcount.
Selling, general, and administrative expenses for the full year 2025 were $87.7 million, compared to $40.1 million in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA as well as increased headcount.
Net loss available to common stockholders was approximately $124.0 million, or $14.57 per basic and diluted share, for the full year 2025, compared to net loss available to common stockholders of $130.0 million, or $176.60 per basic and diluted share, in 2024. The basic and diluted weighted average common shares outstanding for the full year 2025 was 8,511,318 compared to 736,339 shares for 2024.
Fourth Quarter 2025 Financial Results
Net product revenue for the fourth quarter 2025 was approximately $5.4 million, compared to $2.6 million for the same period in 2024, and consisted of combined net sales of TONMYA™, Zembrace® SymTouch®, and Tosymra®. Cost of sales for the fourth quarter 2025 was approximately $1.1 million, compared to $1.2 million for the same period in 2024.
Research and development expenses for the fourth quarter 2025 were approximately $16.9 million, compared to $8.3 million for the same period in 2024. This increase is predominately due to pipeline prioritization period over period and increased headcount.
Selling, general, and administrative expenses for the fourth quarter 2025 were $35.7 million, compared to $15.6 million for the same period in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA and increased headcount.
Net loss available to common stockholders was $46.9 million, or $3.98 per basic and diluted share, for the fourth quarter 2025, compared to net loss available to common stockholders of $22.1 million, or $9.77 per basic and diluted share, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the fourth quarter 2025 was 11,798,945 compared to 2,263,535 shares for the same period in 2024.
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. TONMYATM (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. TONMYA is a 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. 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, 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.
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.
Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Hans Baldau, Associate Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Fourth quarter and FY2025 financial results. Summit will report operating and financial results after the market close on Monday, March 16. Management will host a teleconference at 10 am ET on Tuesday, March 17. We anticipate management will provide its outlook and corporate guidance for 2026.
Noble estimates. We forecasted fourth quarter and FY2025 EBITDA of $62.5 million and $246.6 million, respectively, and net losses of $0.4 million, or $(0.00) per share, and $11.5 million, or $(0.95) per share. Our fourth quarter and full year revenue estimates are $146.7 million and $566.5 million, respectively. Recall management previously communicated that it expected adjusted EBITDA to be at the low end of its $245 million to $280 million 2025 guidance range. For 2026, we are projecting revenue, EBITDA, net income and EPS of $591.3 million, $265.7 million, $12.7 million, and $1.03, respectively.
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This Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
In the most significant emergency energy intervention since the IEA was founded in 1974, the world’s wealthiest nations just deployed their biggest weapon against soaring oil prices — and crude kept climbing anyway. For investors tracking energy markets and small cap stocks in 2026, the implications are impossible to ignore.
On Wednesday, the International Energy Agency announced that all 32 of its member countries unanimously agreed to release 400 million barrels of oil from emergency reserves, the largest coordinated strategic petroleum reserve release in history. The move more than doubles the 182 million barrels deployed in 2022 following Russia’s invasion of Ukraine. The United States committed 172 million barrels from its Strategic Petroleum Reserve alone. Oil prices briefly dipped — then climbed straight back above $90 a barrel before the day was out.
Why the IEA’s Record Oil Reserve Release Failed to Move Markets
The math exposes the problem quickly. Macquarie analysts estimated the 400 million barrel release equates to roughly four days of global oil production and about 16 days of the volume that normally transits through the Strait of Hormuz. As the analysts noted — if that doesn’t sound like much, it isn’t.
Export volumes through the Strait of Hormuz are currently at less than 10% of pre-conflict levels, as shippers continue to avoid the waterway amid active threats and confirmed vessel attacks. The reserve release addresses the symptom. The Strait of Hormuz closure is the disease — and no amount of barrels from emergency stockpiles fixes a shipping lane that remains effectively shut.
There is also a delivery gap that markets priced in immediately. Once a presidential order is issued to deploy oil from the U.S. Strategic Petroleum Reserve, deliveries typically don’t begin for about 13 days, with additional shipping time before volumes reach end consumers. The supply disruption is happening in real time. The relief is weeks away at best. JPMorgan Chase analysts noted that policy measures may have limited impact on oil prices unless safe passage through the Strait of Hormuz is assured.
How the Iran War Oil Price Surge Is Reshaping the Fed’s Path in 2026
This morning’s February CPI report came in at 2.4% year-over-year, with core inflation cooling to 0.2% month-over-month — the softest monthly reading since last summer. Under normal conditions, that data would be a clear runway for continued Federal Reserve rate cuts in 2026. The Iran war has changed those conditions entirely.
February CPI captures none of the oil shock that began when the conflict escalated on February 28. The real inflation print — the one that reflects $87-plus crude flowing into gasoline, airfares, and freight costs — hasn’t landed yet. Futures markets now imply only one full rate cut in 2026 and roughly a 50% probability of a second, a dramatic collapse from the three or four cuts investors were pricing in just weeks ago. The Iran war oil price surge is doing what no economic data had managed to do — it is freezing the Fed.
What Rising Oil Prices Mean for Small Cap and Microcap Stocks
Energy is the only sector trading higher today, and that creates a direct opportunity set in the small and microcap universe. Domestic energy producers, oilfield services companies, and energy infrastructure plays are clear beneficiaries of sustained high crude prices and the global push to source supply outside the Middle East. These are precisely the kinds of under-the-radar names that populate the small cap space and rarely attract attention until a macro event forces investors to find them.
The rate picture is the countervailing risk. The small cap rotation thesis that pushed the Russell 2000 to nearly 9% year-to-date gains was built on continued Fed easing. A prolonged Iran war, sustained crude oil prices above $90, and a Fed on pause separates quality small cap companies from the leveraged names that were simply riding the rate-cut trade.
The IEA’s record oil reserve release in 2026 is not evidence that the crisis is under control. It is evidence of how severe the disruption actually is. When the largest emergency intervention in energy market history fails to bring prices down, the market is sending a signal — and the investors who act on it early are the ones who tend to come out ahead.
Cintas Corporation (Nasdaq: CTAS) announced an agreement to acquire UniFirst Corporation (NYSE: UNF) in a transaction valued at approximately $5.5 billion, marking one of the largest consolidations in the North American uniform and workplace services industry.
The deal brings together two family-founded companies with long histories serving businesses with uniform rental programs, facility services, and workplace safety products. For investors, the transaction highlights a broader trend toward scale and operational efficiency in a fragmented but highly competitive service sector.
Under the terms of the agreement, UniFirst shareholders will receive $155 in cash and 0.7720 shares of Cintas stock for each share held. Based on Cintas’ closing price of $200.77 on March 9, 2026, the consideration represents a combined value of $310 per share for UniFirst. The transaction carries an implied enterprise value of roughly $5.5 billion.
Once combined, the companies will serve approximately 1.5 million business customers across North America, providing uniforms, facility services products, and safety programs to a wide range of industries.
The uniform rental and facility services market has grown increasingly competitive as companies seek larger service footprints and more efficient logistics networks. The combination of Cintas and UniFirst is expected to expand route density, improve processing capacity, and enhance supply chain efficiency.
Cintas management said integrating UniFirst’s service infrastructure and route networks could strengthen the company’s ability to compete with both traditional uniform service providers and alternative procurement models, including direct-purchase programs and hybrid service models.
Operational integration also extends to technology investments, including systems that support route management, inventory tracking, and service delivery optimization.
For investors, these types of scale-driven efficiencies are often central to consolidation strategies in service-heavy industries where route density and logistics can significantly influence operating margins.
Cintas expects to generate approximately $375 million in operating cost synergies within four years following the closing of the transaction. These savings are projected to come from material sourcing efficiencies, production and service cost improvements, and reductions in selling, general, and administrative expenses.
The company also expects the transaction to become accretive to earnings per share by the end of the second full fiscal year after closing.
At closing, Cintas anticipates maintaining a net leverage ratio of roughly 1.5x debt to EBITDA, reflecting a balance between acquisition financing and balance sheet flexibility.
The cash portion of the purchase price will be funded through a combination of cash on hand, committed credit lines, and other financing sources. Morgan Stanley Senior Funding, KeyBank, and Wells Fargo have provided fully committed bridge financing for the transaction.
The boards of directors of both companies have unanimously approved the transaction. Entities affiliated with the Croatti family—founders of UniFirst—control roughly two-thirds of the company’s voting power and have entered into a voting support agreement in favor of the deal.
Members of the Croatti family also plan to retain an ownership position in the combined company, aligning them with the long-term performance of the merged entity.
The transaction is expected to close in the second half of 2026, subject to regulatory approvals and approval from UniFirst shareholders.
Cintas recently reported preliminary fiscal third-quarter revenue of $2.84 billion for the period ending February 28, 2026, representing an 8.9% year-over-year increase and 8.2% organic growth.
UniFirst is scheduled to report its fiscal second-quarter 2026 results on April 1.
If completed as expected, the acquisition would further solidify Cintas’ position as one of the largest providers of uniform rental and facility services in North America, while continuing a broader trend of consolidation across business services sectors where scale, logistics, and customer relationships play critical roles.
Welcome to a multi-part article series authored by leading cross-border M&A professionals from CBIZ, Greenberg Traurig LLP, Noble Capital Markets, and Pathfinder Advisors LLC. This series provides a comprehensive guide for middle-market and larger European companies and investors seeking strategic acquisitions in the U.S. across the manufacturing, distribution, logistics, business services, and retail sectors. It will illuminate the compelling market dynamics, operational advantages, and strategic imperatives driving these transatlantic deals now, while also offering practical insights on navigating the complexities of U.S. market entry, robust financial and operational due diligence, talent integration, and regulatory considerations. The series aims to equip company owners, corporate development executives, family offices, and private equity professionals with the knowledge to unlock significant value and establish a resilient U.S. presence.
In an era defined by rapid economic shifts and evolving global dynamics, European enterprises may now have unprecedented opportunities to look across the Atlantic for strategic growth opportunities. The U.S. market, with its vast scale and inherent resilience, could present a compelling landscape for inbound M&A.
This first article in our series explores why the current climate favors European acquirers and how strategic U.S. acquisitions could unlock significant value and establish a robust, resilient long-term presence.
The webinar below is for company owners, corporate development executives, family offices and private equity professionals considering U.S. acquisitions of expansion.
This article delves into the specific operational and technological advantages awaiting European acquirers in U.S. manufacturing, distribution, and logistics. Acquiring existing U.S. assets in these sectors provides a potent pathway to not only immediate market entry but also the creation of a more resilient, efficient, and technologically advanced global enterprise.
As European manufacturing and logistics firms solidify their North American foundations, a parallel wave of strategic acquisition is transforming the U.S. service and retail landscape. For the European acquirer, the U.S. “Service Economy” represents more than just a massive consumer base; it is a gateway to specialized talent pools, cutting-edge digital platforms, and a resilient commercial ecosystem that can de-risk a global portfolio.
Navigating this transition from “Industrial Footprint” to “Commercial Dominance” requires a nuanced understanding of the U.S. consumer and the specialized expertise that defines American business services.
Additional article in this series will be published periodically. Please follow Noble Capital Markets on LinkedIn to be among the first to know when those are available.
ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.com
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
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Q425. Operating performance in 4Q25 was solid and came in at the upper end of management’s guidance. Revenue came in at $61.2 million, up 6% y-o-y. Adjusted EBITDA grew 24% to $8.1 million, and adjusted EBITDA margin expanded 189 basis points to 13.2%. ISG reported GAAP net income of $2.6 million, or EPS of $0.05/sh, compared to $3.0 million, or EPS of $0.06/sh, last year, which included a $2.3 million gain from the sale of the automation unit. Adjusted EPS was $0.08 versus $0.06 last year.
AI and Recurring Revenue. Management noted AI-related activities represented nearly 35% of quarterly revenue, up from approximately 10% a year ago. For the full year, AI-related revenue accounted for nearly 30% of total revenue, roughly three times last year’s proportion. Recurring revenue totaled $112 million, representing 46% of annual revenue, while recurring revenues grew 13% year-over-year in the fourth quarter. We expect both AI-related and recurring revenue to increase going forward.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
The Federal Reserve faces a complicated policy backdrop after a surprisingly weak February jobs report collided with rising oil prices tied to geopolitical tensions in the Middle East. The conflicting signals highlight the challenge policymakers face as they balance slowing labor market momentum with renewed inflation risks.
The Bureau of Labor Statistics reported that the U.S. economy lost 92,000 jobs in February, while the unemployment rate rose to 4.4% from 4.3% in January. Economists had expected modest job growth, making the decline a notable miss that suggests hiring momentum may be softening.
Despite the negative headline figure, policymakers appear unlikely to move quickly toward rate cuts. Higher oil prices linked to the conflict involving Iran could feed into broader inflation pressures, complicating the outlook for monetary policy.
Federal Reserve officials have indicated that the current environment presents risks on both sides of the economic outlook. Weak labor data could argue for easing policy, but persistent energy price increases could make inflation more difficult to contain.
Some economists believe February’s employment figures were distorted by temporary factors. Healthcare payrolls, one of the most consistent sources of job growth in recent years, were affected by a large Kaiser Permanente worker strike that temporarily removed roughly 30,000 employees from payroll counts. Those positions are widely expected to return in March once the strike activity ends.
Severe winter storms across parts of the country also likely disrupted hiring and payroll reporting during the survey period, potentially exaggerating the weakness in the data.
Even with those temporary disruptions, revisions to prior months suggest hiring momentum had already been slowing. Employment figures for December and January were revised lower by a combined 69,000 jobs, reinforcing the view that labor market growth has cooled compared with the stronger pace seen through much of 2024 and early 2025.
Recent employment gains have also fallen below what economists consider the break-even level needed to keep the unemployment rate stable. With slower population growth tied to declining birth rates and tighter immigration policies, that break-even threshold is now estimated around 30,000 jobs per month, significantly lower than historical levels.
At the same time, structural changes may be shaping hiring behavior across industries. Demographic shifts are gradually reducing labor force participation as older workers retire, while many companies are reassessing workforce needs as artificial intelligence and automation expand into more job functions.
Employers in some sectors appear to be slowing hiring decisions while evaluating how new technologies could fill skill gaps or improve productivity.
These dynamics leave the Federal Reserve navigating a narrow path. A sustained deterioration in labor market conditions could strengthen the case for rate cuts, but rising energy prices could revive inflation concerns just as policymakers believed price pressures were easing.
For now, the central bank may prefer to remain patient and wait for additional economic data before adjusting interest rates.
The February report underscores how quickly the economic narrative can shift. With labor market trends softening, geopolitical tensions influencing energy prices, and structural changes reshaping employment patterns, the Fed may remain in a holding pattern as it evaluates the evolving risks to growth and inflation.
Commercially launched in the U.S. in November 2025, TONMYA (cyclobenzaprine HCl sublingual tablets) for long-term daily dosing at bedtime is the first new FDA-approved treatment for fibromyalgia in adults in more than 15 years
The sublingual TONMYA tablet containing a basifying agent achieved the design objectives of rapid transmucosal absorption and bypassing first-pass liver metabolism
TONMYA was designed to decrease production of the active metabolite norcyclobenzaprine, which is believed to improve the durability of analgesic response in fibromyalgia relative to the transient (~1 month) effects of oral, swallowed cyclobenzaprine
BERKELEY HEIGHTS, N.J., March 05, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced the publication of a paper, “Single-Dose Pharmacokinetic Assessment of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets): Results From Randomized, Open-Label Studies in Healthy Volunteers,” in Clinical Pharmacology in Drug Development, the peer-reviewed journal of the American College of Clinical Pharmacology (ACCP). TONMYA™ was investigated as TNX-102 SL (cyclobenzaprine HCl sublingual tablets) and approved by the U.S. Food and Drug Administration (FDA) on August 15, 2025, for the treatment of fibromyalgia in adults. The manuscript can be accessed at: https://accp1.onlinelibrary.wiley.com/doi/10.1002/cpdd.70034.
“These data demonstrate the importance of the proprietary basifying agent in TONMYA’s sublingual formulation,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “An earlier study conducted by Tonix showed that transmucosal delivery cannot be achieved by simply applying a liquid cyclobenzaprine HCl formulation under the tongue. Due to the basifying agent ingredient, sublingual TONMYA achieves rapid transmucosal absorption that bypasses first-pass hepatic metabolism. This pharmacokinetic profile underpins TONMYA’s unique sublingual formulation, which is designed to increase parent drug exposure during sleep while reducing exposure and side effects to the long half-life, active metabolite.”
Dr. Lederman continued, “Bedtime oral swallowed cyclobenzaprine was one of the first drugs studied as a treatment for fibromyalgia, but it failed because the benefits were only transient (~1 month) and fibromyalgia is a chronic condition requiring durable responses.1 Our design objective for TONMYA was to improve the durability of cyclobenzaprine’s treatment effect by decreasing liver production of the major active metabolite norcyclobenzaprine, which we believe counteracted the benefits of swallowed cyclobenzaprine over time. We believe the clinical pharmacology studies published in Clinical Pharmacology in Drug Development, show that TONMYA achieved this design objective. Later studies2,3 confirmed that TONMYA as a daily bedtime medicine provides a durable analgesic benefit to fibromyalgia patients and is generally well tolerated.”
The publication reports findings from two Phase 1 single-dose, open-label studies conducted in healthy adult volunteers.
In Study 1 (n=24), three sublingual formulations of cyclobenzaprine HCl 2.8 mg, each containing a different basifying agent, were compared with oral immediate-release (IR) cyclobenzaprine HCl 5 mg under fasting conditions. All sublingual formulations showed rapid absorption and increased relative bioavailability compared with oral IR cyclobenzaprine HCl. The potassium phosphate dibasic formulation (designated TNX-102 SL) demonstrated the most favorable pharmacokinetic profile, with a 154% relative bioavailability compared to oral IR, an absorption lag of approximately 3 minutes versus approximately 37 minutes for oral IR, and a 783% higher dose-normalized AUC during the first hour post-dose. Based on these results, the potassium phosphate dibasic formulation was selected for further clinical development.
In Study 2 (n=16), TNX-102 SL 2.8 mg and 5.6 mg were evaluated in a crossover design under fasting and fed conditions. The formulation exhibited dose proportionality between the two dose levels, and pharmacokinetic parameters were not affected by a high-calorie, high-fat meal, confirming the absence of a food effect. This study also provided a full clinical characterization of the active metabolite norcyclobenzaprine, demonstrating an elimination half-life of approximately 60 hours. Reduced exposure to norcyclobenzaprine following sublingual administration, as compared with oral delivery, is believed to contribute to the improved durability of efficacy and favorable tolerability profile observed with TONMYA in Phase 3 fibromyalgia studies.2,3
Across both studies, single-dose sublingual cyclobenzaprine HCl was generally well tolerated. All treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse events were oral hypoesthesia and abnormal taste. No serious adverse events were reported, and no clinically meaningful changes were observed in laboratory parameters, vital signs, or electrocardiogram findings.
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-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™ (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 TNX-102 SL 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. 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. 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.
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.
BERKELEY HEIGHTS, N.J., March 03, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, today announced that it has received approval from Nasdaq to transfer the listing of its common stock from the Nasdaq Capital Market to the Nasdaq Global Select Market. Trading on the Nasdaq Global Select Market is expected to commence at the open of market on March 3, 2026, under the Company’s existing ticker symbol “TNXP.”
The uplisting to the Nasdaq Global Select Market reflects the Company’s compliance with the Nasdaq Global Select Market’s higher financial and corporate governance standards. The transition to this higher tier of the Nasdaq market may enhance the Company’s visibility among institutional investors, improve liquidity and broaden market recognition.
“Uplisting to the Nasdaq Global Select Market is an important milestone for Tonix,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We look forward to leveraging this enhanced platform to drive growth and create value for our shareholders. We’re grateful for the support that has brought us here and excited about what’s ahead.”
The Nasdaq Global Select Market is the highest of the three Nasdaq market tiers and is designed for companies that meet higher financial, liquidity and corporate governance requirements than those of the Nasdaq Capital Market and the Nasdaq Global Market. The Company believes that trading on this tier will further enhance its reputation with customers, partners and investors. Companies at this level may experience increased trading volumes and greater access to institutional investors. Meeting the Global Select Market’s higher financial and corporate governance standards may also signal to the market that a company has achieved financial and operational growth.
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 2.8mg), 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.
* 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.
This press release and further information about Tonix can be found at www.tonixpharma.com.
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. 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.
The US and Israeli strikes on Iran have rattled global markets, triggering sharp swings in oil, gold, and equities. Brent crude surged, gold climbed, and the S&P 500 whipsawed as investors grappled with the possibility of a prolonged conflict.
Whenever geopolitical tensions erupt, the first market reaction is often dramatic. Energy prices spike on supply fears. Gold rallies as investors seek safety. Stocks wobble amid uncertainty.
But history suggests that the first move is rarely the lasting one.
A review of past geopolitical shocks — including Iraq’s invasion of Kuwait in 1990, the Sept. 11 attacks, the 2003 Iraq War, US intervention in Libya, and Russia’s invasion of Ukraine — shows a consistent pattern. Markets tend to react sharply in the opening days, only to moderate or reverse course within weeks.
Consider the 12-day conflict between Israel and Iran in June 2025. When hostilities began on June 13, oil and gold jumped immediately while stocks fell.
Brent crude rose roughly 7% in the first trading session following the outbreak of fighting. Yet 30 trading days later, oil prices were slightly below where they had started.
Gold followed a similar trajectory. An initial pop of about 1.5% gave way to a modest decline over the next month.
Equities moved in the opposite direction. The S&P 500 fell just over 1% on the first day of trading after the conflict began but was up nearly 6% a month later.
The lesson: initial fear-driven moves do not necessarily define the medium-term trend.
The same dynamic appeared after other major events. Gold surged nearly 7% in the first trading session after the Sept. 11, 2001 attacks, reflecting a rush into safe-haven assets. But over the subsequent 30 trading days, gains were far more moderate.
Oil’s reaction to Russia’s invasion of Ukraine in 2022 was even more dramatic. Prices spiked more than 30% in the early days of the conflict amid fears of supply disruptions. Yet a month later, oil’s net gain had narrowed significantly.
Across multiple episodes, the direction of prices after the first day matched the direction one month later only slightly more than half the time. In other words, a sharp spike — or drop — offers limited predictive power.
There is, however, at least one important exception.
When Iraq invaded Kuwait in August 1990, oil prices jumped more than 11% on the first day and continued climbing, rising nearly 57% over the following month. Stocks also continued their downward trajectory, with the S&P 500 falling more than 10% over 30 trading days.
Even in that case, however, markets eventually recovered after allied forces expelled Iraqi troops from Kuwait.
The current conflict may ultimately chart its own course. The scale of military action, potential energy supply disruptions, and broader geopolitical consequences all remain fluid. Analysts have cautioned that it is simply too early to project where prices will settle in the weeks ahead.
Still, history offers a measured perspective. Markets often overshoot in moments of crisis, pricing in worst-case scenarios before recalibrating as new information emerges.
For investors, that pattern underscores a familiar reality: volatility may dominate the headlines in the first days of a global shock, but longer-term outcomes are rarely determined by the opening move alone.
