Category: 3. Business

  • Copper price on track for biggest rise in 15 years amid global shortage fears | Commodities

    Copper price on track for biggest rise in 15 years amid global shortage fears | Commodities

    Copper, the metal that underpins the fast-growing renewable energy industry, is on course for its biggest annual price rise in more than 15 years as traders react to fears of global shortages.

    As one of the main beneficiaries of the “electrification of everything”, copper has soared by more than 35% in value this year, spurred by US tariff uncertainty and concerns about mining disasters that could restrict supply.

    Analysts said copper had also joined silver and gold as a safe haven asset for investors wanting to hedge against the falling value of the dollar.

    Silver reached a record high on Monday, pushing the value of the Mexican mining company Fresnillo, which is listed on the London stock market, to a record high this month. The price of gold has jumped above $4,400 (£3,263) an ounce, up more than 70% since the beginning of January.

    Kyle Rodda, a senior financial market analyst at the investment company Capital.com, said the rise of copper, gold and silver “demonstrates a world marked by greater scarcity and investors desire to get their hands on things with relatively limited supply”.

    The copper price rose to more than $12,000 a tonne in December after the biggest rise since the global recovery in the wake of the 2008 financial crash.

    There was a rush to buy copper by US companies earlier this year after Donald Trump threatened to slap extra tariffs on imports of the metal. The tariffs were suspended, but the hoarding effect has limited supplies in other parts of the world and helped drive global prices higher.

    Copper is often viewed as a barometer for the global economy. It plays a central role in power grids, construction and industrial machinery.

    China, which is the largest manufacturer of copper products, has made securing supplies a priority, adding to the rise in prices.

    On Christmas Day, the state-owned miner Jiangxi Copper said it had acquired all shares of the London-listed miner SolGold for $1.2bn, allowing it to take control of the Cascabel gold and silver mining operation run by SolGold in Ecuador.

    Analysts at Goldman Sachs said earlier this month that the copper price was likely to stabilise in response to figures showing there was more than enough copper in circulation to meet global demand.

    However, concerns have grown that short-term hoarding in the US and China and the rising demand for copper over the next two decades will mean that supply fails to keep pace, especially as nations seek to switch from oil and gas to renewable sources of energy, driven by electricity from wind and solar farms.

    However, several mines have recently been forced to shut down after accidents.

    The US miner Freeport-McMoRan said in September that it would be unable to fulfil contracts to customers after a fatal mudslide at its sprawling Grasberg copper and gold mine in Indonesia.

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  • Loblaw stores and customers raise and donate more than $6.8 million in support of PC Children’s Charity throughout 2025

    Results, driven largely by Fall ‘Get to Give Days’ campaign, have helped the Charity reach its goal of feeding 1 millions kids annually

    Brampton, ON – December 29, 2025 – In 2025, thanks to the generosity of customers all across the country, Loblaw Companies Limited raised and donated over $6.8 million in support of President’s Choice Children’s Charity – operators of Canada’s largest charitable direct-to-school food program.

    Much of the funds were raised during the company’s ‘Get to Give Days’ campaign, which ran from October 16 to November 2. During this time, the company pledged to match customer donations made at checkout, up to $2 million. Customer response to the program was outstanding, leading to a $2.6 million donation to the Charity. Customers also gave at cash all throughout the year, either through a direct appeal, or most recently via a bill round-up.

    As a result of this incredible generosity, this year, PC Children’s Charity was able to reach its goal of feeding 1 million kids annually through its signature program, Power Full Kids Eat Well, which reaches children and youth in approximately 2,200 schools across Canada. This program has a dual purpose: to remove hunger as a barrier to learning for children, and to teach them how to grow and cook food, promote healthy habits, develop life skills, and build self-confidence.

    “We are forever grateful to Canadians, and Loblaw, for their giving spirit,” said Shantelle Rhynold, Director, PC Children’s Charity. “This campaign, in part, helped us to achieve our longstanding goal of feeding 1 million kids annually. We know it takes a village to raise up our youth, and in every part of the country, we saw Canadians helping to make our purpose a reality.”

    About President’s Choice Children’s Charity (Charitable Registration: 86842 1546 RR0001)

    For 36 years, President’s Choice Children’s Charity has been dedicated to helping children across Canada, and in that time, has nurtured the wellbeing of over 10 million children. Since 2018, the charity has been committed to the fight against childhood hunger to ensure all Canadian children can live the life they choose. President’s Choice Children’s Charity operates the nation’s largest charitable direct-to-school food program and its Power Full Kids programming combines regular meals and snacks with food skills education. The charity’s ambition is to feed one million children every year, by 2025.

    For more information or to give, visit www.pcchildrenscharity.ca(Open in a new tab) or follow on Facebook, Instagram or X.

    About Loblaw Companies Limited:

    Loblaw is Canada’s food and pharmacy leader, and the nation’s largest retailer. Loblaw provides Canadians with grocery, pharmacy, and healthcare services, other health and beauty products, apparel, general merchandise, financial services and wireless mobile products and services. With more than 2,800 locations, Loblaw, its franchisees and Associate-owners employ more than 220,000 full- and part-time employees, making it one of Canada’s largest private sector employers.

    Loblaw’s purpose, Live Life Well®, puts first the needs and well-being of Canadians who make one billion transactions annually in the company’s stores. Loblaw is positioned to meet and exceed those needs in many ways: convenient locations; more than 1100 grocery stores that span the value spectrum from discount to specialty; full-service pharmacies at almost 1400 Shoppers Drug Mart® and Pharmaprix® locations and almost 500 grocery stores; PC Financial® financial services; Joe Fresh® fashion and family apparel; and four of Canada’s top consumer brands in Life Brand®, Farmer’s MarketTM, no name® and President’s Choice®. For more information, visit Loblaw’s website at www.loblaw.ca and Loblaw’s issuer profile at www.sedar.com(Open in a new tab).

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  • Vestas announces orders in Ireland for a total of 188 MW

    Vestas announces orders in Ireland for a total of 188 MW

    Press Release:

    News release from Vestas Northen and Central Europe
    Hamburg, 29 December 2025

    Vestas is proud to announce the following orders as part of our Q4 order intake:

    Country Region Customer Project name MW Turbine variant Service agreement Delivery & commissioning
    Ireland EMEA Undisclosed Undisclosed 99 22 x V136-4.5 MW 20-year AOM 5000 Service Agreement Delivery planned to begin in Q1 2027; commissioning scheduled to begin in Q3 2027
    Ireland EMEA Undisclosed Undisclosed 47 11 x V117-4.3 MW Undisclosed Undisclosed
    Ireland EMEA Invis Energy Knocknamork 42 7 x V150-6.0 MW 20-year AOM 5000 Service Agreement Delivery planned to begin in Q3 2026; commissioning scheduled to begin in Q2 2027

    For more information, please contact:
    Yannick Kramm
    External Communications Specialist, Vestas Northern & Central Europe 
    Mail: yankr@vestas.com
    Tel: +44 (0)77 9528 4694
    Yannick Kramm

    About Vestas
    Vestas is the energy industry’s global partner on sustainable energy solutions. We design, manufacture, install, and service onshore and offshore wind turbines across the globe, and with more than 197 GW of wind turbines in 88 countries, we have installed more wind power than anyone else. Through our industry-leading smart data capabilities and unparalleled more than 159 GW of wind turbines under service, we use data to interpret, forecast, and exploit wind resources and deliver best-in-class wind power solutions. Together with our customers, Vestas’ more than 37,000 employees are bringing the world sustainable energy solutions to power a bright future.

    For updated Vestas photographs and videos, please visit our media images page on: https://www.vestas.com/en/media/images

    We invite you to learn more about Vestas by visiting our website at www.vestas.com and following us on our social media channels:

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  • Johnson & Johnson completes acquisition of Halda Therapeutics and its novel platform to revolutionize cancer treatment and enable next-generation oral therapies

    NEW BRUNSWICK, NJ (December 29, 2025) – Johnson & Johnson (NYSE: JNJ) (the “Company”) today announced the successful completion of its acquisition of Halda Therapeutics OpCo, Inc. (“Halda”), a clinical-stage biotechnology company with a proprietary Regulated Induced Proximity TArgeting Chimera (RIPTAC™) platform to develop oral, targeted therapies for multiple types of solid tumors, including prostate cancer, for $3.05 billion in cash.

    “This strategic milestone underscores our commitment to redefining cancer treatment with breakthrough science and transformative medicines,” said Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson. “We are excited to formally welcome the talented Halda team to Johnson & Johnson and look forward to working together to achieve our shared goal of eliminating cancer.”

    With this acquisition, Johnson & Johnson adds HLD-0915, a clinical-stage therapy for prostate cancer, building on the Company’s nearly two decades of innovation in this disease area. HLD-0915 is a once-daily oral therapy that uses a novel RIPTAC™ platform with a precision cancer cell-killing approach that can overcome mechanisms of resistance to treatment. Additionally, the Company adds several earlier candidates for breast, lung and multiple other tumor types, based on RIPTAC™ technology, to its leading oncology portfolio. The novel technology may also enable the creation of transformative targeted therapies beyond oncology.

    “Johnson & Johnson continuously seeks new ways to meet patient needs and deliver innovative therapies,” said John C. Reed, M.D., Ph.D., Executive Vice President, Innovative Medicine, R&D, Johnson & Johnson. “Now that we have finalized this acquisition, we will focus on advancing the potential of this promising pipeline of novel product candidates and harnessing the powerful RIPTAC™ platform to discover more molecules in oncology and beyond.”

    The acquisition will be accounted for as a business combination. With the transaction now closing in 2025, Johnson & Johnson expects dilution in Q4 2025 and 2026 earnings. The total dilution to Adjusted Earnings Per Share (EPS) of approximately $0.20 is expected to split equally between 2025 and 2026 based on the latest estimates for the non-recurring charge related to Halda employee equity awards, financing and integration costs. Johnson & Johnson will provide commentary on full year 2026 guidance during the fourth quarter earnings call on Wednesday, January 21, 2026.

    About Johnson & Johnson
    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.

    Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com. Follow us @JNJInnovMed.

    Caution Concerning Forward-Looking Statements:
    This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 related to the acquisition of Halda. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current beliefs, expectations, and assumptions regarding future events, and are subject to uncertainties, risks and changes that are difficult to predict and many of which are outside of Johnson & Johnson’s control. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results and financial condition could vary materially from the expectations and projections Johnson & Johnson expressed or implied in its forward-looking statements. Risks and uncertainties include, but are not limited to: the satisfaction of closing conditions for the acquisition; the possibility that the transaction will not be completed in the expected timeframe or at all; the potential that the expected benefits and opportunities of the acquisition, if completed, may not be realized or may take longer to realize than expected; challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals; uncertainty of commercial success for new products; economic conditions, including currency exchange and interest rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to applicable laws and regulations, including tax laws and global health care reforms; adverse litigation or government action; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; and trends toward health care cost containment. In addition, if and when the transaction is consummated, there will be risks and uncertainties related to the ability of the Johnson & Johnson family of companies to successfully integrate Halda as well as the ability to ensure successful development and regulatory approval of Halda’s programs. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com, www.investor.jnj.com or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.


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  • US stocks eclipsed by rest of world in 2025 as investors diversify

    US stocks eclipsed by rest of world in 2025 as investors diversify

    Unlock the Editor’s Digest for free

    US stocks have been eclipsed by market gains in the rest of the world in 2025, as worries about high valuations, a Chinese artificial intelligence breakthrough and Donald Trump’s radical economic policies contributed to a rare year of underperformance for Wall Street.

    The S&P 500 is up 18 per cent this year, undershooting the 29 per cent gain for the MSCI All Country World ex-US index by the widest margin since the global financial crisis in 2009.

    Wall Street’s artificial intelligence boom has powered a rebound from the sell-off sparked by Trump’s “liberation day” tariff blitz in April.

    But the lingering effects of the president’s trade war — as well as anxieties over sky-high US tech valuations — have led many investors to question the dominant position in global portfolios long enjoyed by US stocks.

    “US equities are more expensive than lots of other equities, the growth trajectory is likely to be challenged, and everyone’s got lots of them,” said Matthew Beesley, chief executive of Jupiter Asset Management, describing his approach to equity investing in 2026 as “anything but America”.

    “That is a great time to think about anything [investors] haven’t got lots of,” he added.

    Indices in China, Japan, Germany and the UK have outperformed the S&P as relatively unloved markets made a comeback, while an MSCI gauge of emerging markets has climbed nearly 30 per cent, boosted by a weaker dollar.

    “There is a need to diversify risk,” said Niamh Brodie-Machura, chief investment officer for equities at Fidelity International. “Many of the investors I talk to are examining their geographical allocations in light of the big-picture events of the past year.”

    Asian stock markets have been among the strongest performers, buoyed in part by Chinese start-up DeepSeek, which raised the prospect of serious competition to US AI with its large language model breakthrough in January.

    The MSCI China is up more than 30 per cent, while Hong Kong’s Hang Seng has climbed almost 28 per cent.

    US chipmaker Nvidia dropped 17 per cent on a single day following the release of a DeepSeek model whose performance rivalled those of US competitors but at a lower cost, prompting investors to question whether vast investment in AI infrastructure was necessary.

    Although Nvidia stormed back to become the world’s first $5tn company in October, nagging doubts about AI valuations have hit the US market, fuelling a sharp November sell-off.

    “The reason we lost that exuberance [about US stocks] was really in January . . . DeepSeek day,” said Helen Jewell, chief investment officer for fundamental equities at BlackRock. “You had that sudden realisation that ‘too overweight the US’ was not the way to build a portfolio.”

    Global investors have also warmed to Chinese equities this year. Mislav Matejka, head of global and European equity strategy at JPMorgan, said that the bank “fully flipped” to an overweight position on China this year following signs of economic resurgence.

    South Korea’s Kospi index has soared more than 75 per cent this year, with the index’s tech heavyweights Samsung and SK Hynix up 124 per cent and 268 per cent respectively.

    European stocks, too, enjoyed a boost prompted by hopes of economic growth emerging from Germany’s “whatever it takes” fiscal stimulus package, which most investors expect to kick off in earnest next year.

    Germany’s Dax has outperformed the S&P 500, while strong economic growth has driven Spain’s Ibex 35 up 48 per cent and the Greek Athex index up 44 per cent.

    “For years, the US was the only story in town,” said JPMorgan’s Matejka. Now, he said, investors should be positioning for this “broadening of performance internationally”.

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  • Tonix Pharmaceuticals Holding Corp. (TNXP)

    Tonix Pharmaceuticals Holding Corp. (TNXP)





    CHATHAM, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial stage biotechnology company, today announced it has entered into a securities purchase agreement with Point72 for the purchase and sale of 615,025 shares of its common stock at an offering price of $16.26 per share and, in lieu of shares of common stock, pre-funded warrants to purchase up to an aggregate of 615,025 shares of common stock at a purchase price of $16.259 per pre-funded warrant, which equals the offering price per share of the common stock less the $0.001 per share exercise price of each pre-funded warrant. The closing of the offering is expected to take place on or about December 30, 2025, subject to the satisfaction of customary closing conditions.

    The gross proceeds of the offering will be approximately $20.0 million before deducting placement agent fees and other estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the offering to fund the commercialization of its marketed products, the development of its product pipeline, and general working capital and corporate purposes.

    TD Cowen is acting as sole placement agent for the offering. A.G.P./Alliance Global Partners is acting as a financial advisor.

    This offering is being made pursuant to an effective shelf registration statement on Form S-3 (File No. 333-287965) previously filed with the U.S. Securities and Exchange Commission (the “SEC”). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov. Electronic copies of the prospectus supplement may be obtained, when available, from TD Securities (USA) LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by email at TDManualrequest@broadridge.com.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.

    Tonix Pharmaceuticals Holding Corp.*
    Tonix is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYA™, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md.

    * 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.

    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
    Mary Ann Ondish
    Tonix Pharmaceuticals
    maryann.ondish@tonixpharma.com

    Ray Jordan 
    Putnam Insights 
    ray@putnaminsights.com 

    INDICATION
    TONMYA is indicated for the treatment of fibromyalgia in adults.

    CONTRAINDICATIONS
    TONMYA is contraindicated:
    In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

    During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism.

    WARNINGS AND PRECAUTIONS
    Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

    Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.

    Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

    Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

    CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

    ADVERSE REACTIONS
    The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

    DRUG INTERACTIONS

    MAO inhibitors: Life-threatening interactions may occur.

    Other serotonergic drugs: Serotonin syndrome has been reported.

    CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

    Tramadol: Seizure risk may be enhanced.

    Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

    USE IN SPECIFIC POPULATIONS
    Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

    Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

    Pediatric use: The safety and effectiveness of TONMYA have not been established.

    Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

    Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

    Please see additional safety information in the full Prescribing Information.
    To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    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.

    Source: Tonix Pharmaceuticals Holding Corp.

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  • Public Interest and Insolvency in the UAE : Clyde & Co

    Public Interest and Insolvency in the UAE : Clyde & Co

    The United Arab Emirates has established a sophisticated legal framework for financial restructuring and bankruptcy, most recently embodied in Federal Decree Law No. 51 of 2023 (the Insolvency Law). The Insolvency Law is not only a technical instrument addressing debtor and creditor interests but also a legislative tool designed to protect the broader public interest and uphold public order. The concept of public order is deeply embedded in UAE law, including its Constitution and judicial practice, and plays a decisive role in shaping the application and interpretation of bankruptcy proceedings.

    Public order in the UAE legal system

    Public order in the UAE is a foundational legal principle, referenced explicitly in the Constitution and often invoked by the courts. Article 44 of the UAE Constitution states that “respect of the Constitution, the laws and the orders issued by the public authorities in execution thereof, compliance with the public order, and respect of public moral are duties binding to all the people living in the UAE.

    Public order is understood as encompassing the ultimate interests of society and the ethical, economic, and political foundations of the state.

    The UAE’s bankruptcy law is expressly recognised as a matter of public order. The Abu Dhabi Court of Cassation has affirmed that the rules and procedures governing bankruptcy are not merely contractual or private in nature but are mandatory provisions that serve the collective interests of society. In a landmark 2024 decision, the court annulled an arbitral award that conflicted with bankruptcy proceedings, ruling that the exclusive jurisdiction of bankruptcy courts and the mandatory nature of bankruptcy procedures are integral to public order. The court stated that public order is “one of the essential safeguards the respect of which is a priority in all acts and judgments, for it is relating to the ultimate interest of the society and to the social or political or economic or ethical basis on which the State is founded“. 

    Balancing private and public interests

    The Insolvency Law articulates clear objectives that go beyond the interests of debtors and creditors in assisting debtors in settling debts and preserving the rights of creditors. The law aims to maintain the vitality of the national economy and protect jobs and maintain business continuity.

    These objectives reflect a legislative intent to balance private interests with the protection of the credit system and the broader public interest. The law empowers courts to exercise discretion when assessing public order, such as by authorising selective payments to critical suppliers or employees when necessary to prevent greater social costs.

    In practice, the concept of public interest operates as a governing standard throughout bankruptcy proceedings. Courts, trustees, and creditors are required to consider the broader economic and social impact of their decisions at every stage, including at the following stages:

    1. Commencement of proceedings: Courts assess whether starting bankruptcy proceedings will stabilise wages, supply chains, and affect a group of creditors.
    2. Reorganisation vs. liquidation: The law mandates a careful assessment of job preservation and the social consequences of liquidation.
    3. Assessment of critical suppliers and wages: Exceptions to the pari passu principle (equal treatment of creditors) are permitted when justified by public interest.
    4. Approval of plans: Reorganisation plans must demonstrate feasibility, fairness, and visible public benefits, such as job preservation and market stability. 

    The UAE judiciary has consistently enforced the public order nature of bankruptcy law. For example, the Abu Dhabi Court of Cassation annulled an arbitral award that conflicted with bankruptcy proceedings, emphasising that bankruptcy court jurisdiction is exclusive and mandatory, and that arbitration agreements are inoperative in bankruptcy cases.

    Conclusion

    Bankruptcy law in the UAE is not merely a set of private rules that governs the interests of debtors and creditors but a public order regime designed to protect economic stability, market confidence, and the interests of society as a whole. Courts, trustees, and creditors are all bound to act in accordance with public order, ensuring that bankruptcy proceedings serve not only the parties involved but also the broader public good.

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  • 5 things to know before the stock market opens Monday

    5 things to know before the stock market opens Monday

    Traders work on the floor at the New York Stock Exchange in New York City, U.S., Dec. 17, 2025.

    Brendan McDermid | Reuters

    This is CNBC’s Morning Squawk newsletter. Subscribe here to receive future editions in your inbox.

    Here are five key things investors need to know to start the trading day:

    1. Green Christmas

    Joy to the investor! While some market participants worried that the so-called Santa Claus rally wouldn’t materialize this year, the major indexes all notched wins in last week’s holiday-shortened trading period. The S&P 500 also gave traders the gift of new all-time highs.

    Here’s what to know:

    • The three major indexes climbed more than 1% a piece last week, marking each index’s fourth positive week in the last five.
    • Despite ending Friday’s session slightly lower, the benchmark S&P 500 still logged fresh intraday records and got within 1% of the 7,000 milestone.
    • It’s another shortened trading week with the stock market closed Thursday for New Year’s Day.
    • Plus, it’s a light week for economic data and corporate earnings. However, investors will keep an eye on minutes from the Federal Reserve’s December meeting due out New Year’s Eve.
    • Follow live markets updates here.

    2. Miles to go before I sleep

    A United Airlines plane prepares to land at LaGuardia Airport (LGA) in the Queens borough of New York, US, on Friday, Dec. 26, 2025.

    Michael Nagle | Bloomberg | Getty Images

    Thousands of flights were canceled or delayed over the weekend as a major winter storm hit the Northeast U.S. The disruptions come during the busy holiday travel period, when more than 50 million people are expected to fly.

    As CNBC’s Leslie Josephs reports, airlines including American, Delta, United, Southwest and JetBlue waived change fees last week for travelers flying in and out of several airports in the Northeast. But customers need to travel by the end of the year — in other words, by the time the Times Square ball drops — if they changed their travel plans due to the storm.

    3. Peace talks

    U.S. President Donald Trump looks at Ukrainian President Volodymyr Zelenskyy upon his arrival for meetings at Trump’s Mar-a-Lago club in Palm Beach, Florida, on Dec. 28, 2025.

    Jonathan Ernst | Reuters

    President Donald Trump spent yesterday talking with Ukrainian and Russian leaders as he continued to push for a peace deal between the two countries.

    Trump welcomed Ukrainian President Volodymyr Zelenskyy to his Mar-a-Lago resort in Florida. Before beginning talks, Trump said that “we have the makings of a deal that is good for Ukraine” and “good for everybody.” Afterward, Trump said “we’re getting a lot closer” to an agreement. Zelenskyy said this morning that he asked Trump for up to 50 years of security guarantees for Ukraine.

    Earlier on Sunday, Trump said in a Truth Social post that he had a “good and very productive telephone call” with Russian President Vladimir Putin. Trump said he planned to call Putin again after finishing his meeting with Zelenskyy.

    Get Morning Squawk directly in your inbox

    4. Fact or fiction

    Nvidia President and CEO Jensen Huang (C) speaks to the media as he arrives for a meeting with the Senate Banking Committee on Capitol Hill on December 3, 2025 in Washington, DC.

    Anna Moneymaker | Getty Images

    Groq is calling Nvidia’s acquisition of its top talent a “non-exclusive licensing agreement.” Bernstein analyst Stacy Rasgon said in a report that the structure may be used to avoid antitrust concerns and “keep the fiction of competition alive.”

    As CNBC’s Ari Levy reports, Groq would be Nvidia’s largest acquisition on record. But the world’s most valuable company is instead choosing to pay for the startup’s top talent and access to its technology through licensing — a popular strategy among major tech firms in recent years.

    For some on Wall Street, the agreement underscores Nvidia’s ballooning size. “They’re so big now that they can do a $20 billion deal on Christmas Eve with no press release and nobody bats an eye,” Rasgon told CNBC’s “Squawk on the Street” on Friday.

    5. Happy meal

    A sign advertises meal deals at a McDonald’s restaurant on July 22, 2024 in Burbank, California.

    Mario Tama | Getty Images

    Value was a hot topic among some restaurant chains this year as they tried to keep price-conscious consumers coming in their doors. McDonald’s extended its $5 value meal and brought back Extra Value Meals. Taco Bell followed suit by expanding its Luxe Cravings box offerings this year.

    As CNBC’s Amelia Lucas reports, that strategy will likely stick around in 2026.

    The emphasis on value comes as data shows diners are more focused on costs after years of high inflation. But not all restaurant chains have jumped on the bandwagon: Fast-casual restaurants like Chipotle and Cava have tried to avoid discounting and instead zeroed in on quality.

    The Daily Dividend

    Here’s what we’re watching in this four-day trading week:

    • Wednesday: Fed meeting minutes
    • Thursday: Stock market closed for New Year’s Day

    CNBC Pro subscribers can see a calendar and rundown for the week here.

    CNBC’s Sean Conlon, Sarah Min, Leslie Josephs, Hugh Son, Holly Ellyatt, Ari Levy and Amelia Lucas contributed to this report. Josephine Rozzelle edited this edition.

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  • Tonix Pharmaceuticals Holding Corp. (TNXP)

    Tonix Pharmaceuticals Holding Corp. (TNXP)





    Exploring clinical development plan options including a controlled human infection model (CHIM) and a Phase 2/3 adaptive field study

    Expect to have investigational product of TNX-4800 (anti-Borrelia OspA mAb) available for clinical trials in early 2027

    Approximately 70 million people that live, work or vacation in areas of the U.S. in which Lyme disease is endemic could potentially benefit from pre-exposure prophylaxis

    CHATHAM, N.J., Dec. 29, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial stage biotechnology company, today announced program updates on TNX-4800 (formerly known as mAb 2217LS)1,2, which is a long-acting human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the causative agent of Lyme disease in humans. TNX-4800 is being developed for annual seasonal use, as one subcutaneous administration in the spring to protect against Lyme disease through fall, or the entire tick season in the U.S. There are no currently marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

    “We plan to meet with the FDA in 2026 to explore Phase 2/3 development options,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We believe a controlled human infection model (CHIM)3-5 study using Borrelia-infected ticks that mimics natural infection would be a potential path to demonstrating TNX-4800 efficacy for approval. We are on a path to have investigational product produced under Good Manufacturing Practices (GMP) available for testing early in 2027. We believe TNX-4800’s long-acting mAb prophylaxis could play an important role for preventing Lyme for millions of people who live, work, and vacation in regions endemic for Lyme disease. TNX-4800 provides near-immediate immunity to the bacteria that cause Lyme disease after a single administration, which is very different from Lyme disease vaccine programs currently in development. Prophylaxis with TNX-4800 may also avoid the limitations of vaccine products designed to actively immunize against Lyme, including suboptimal immune responses from age, immunocompetence, and other reasons.”

    About TNX-4800
    TNX-4800 (formerly known as mAb 2217LS) is a fully human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. By binding OspA when TNX-4800 containing blood is ingested by the tick, TNX-4800 kills and blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. Published work in non-human primates showed that TNX-4800 was 95% effective in preventing infection after 6 days of exposure to ticks infected with Borrelia burgdorferi.1 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its crystallizable fragment (Fc) domain which served to prolong the serum half-life. A single administration in the Spring is designed to provide immunity within two days and maintain protective antibody titers for the entire tick season, providing pre-exposure prophylaxis against Lyme disease without relying on the recipient’s immune system to generate antibodies. By delivering a well-characterized antibody directly, TNX-4800 has been shown to block transmission of the major Borrelia genospecies from ticks to animals. TNX-4800 also sidesteps the multidose schedules required for OspA vaccines in development6 and FDA-approved vaccines that have been withdrawn from the market due to concerns about increased risk of autoimmunity.7 Tonix intends to advance TNX-4800 through additional clinical trials with the goal of submitting a Biologics Licensing Application (BLA) to the FDA.

    About TNX-4800 Pharmacokinetics
    TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, pharmacokinetics (PK), and immunogenicity of TNX-4800 in healthy adults. Forty-four subjects were randomized and 41 completed the study. Subjects received a single subcutaneous (SC) administration of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Drug exposure increased by approximately 25-times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of 24 hours, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses (i.e., ≥ 1.5 mg/kg). Mean half-life ranged from 62–69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most subjects. Mean exposure for the 10 mg/kg cohort was less than 20% of the highest exposures in a rat toxicology study. Anti-drug antibodies (ADA) were detected in <10% of treated subjects, with no impact on PK. Most adverse events were mild or moderate. TNX-4800 was determined to be generally safe and well tolerated.

    About Lyme Disease 
    In the United States, Lyme disease is caused by the bacterium Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States and its incidence is climbing each year.8 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, the heart, and the nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed, and even with treatment, up to 20% of cases may progress to a Post-Treatment Lyme Disease Syndrome (PTLDS) called “Chronic Lyme” or “Long Lyme”. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue and other symptoms.9

    About Borrelia Burgdorferi
    In infected deer ticks, Borrelia’s OspA lipoprotein binds to tick-gut receptor TROSPA and helps it adhere to the midgut lining. During a tick bite blood meal, Borrelia downregulates OspA, upregulates OspC, and activates motility genes. Borrelia undergoes a metamorphic-like transformation, becoming highly flagellated and mobile, which facilitates migration to the tick salivary glands and invasion of human host tissues. During a tick bite of an animal pre-treated with TNX-4800, the tick ingests host blood containing TNX-4800, which kills and blocks the metamorphic-like transformation of Borrelia in the tick’s midgut preventing transmission of the bacteria. Lyme-causing Borrelia-exposed or -infected individuals, rarely make antibodies against OspA which allows for people to be reinfected despite having immunity to OspC. Consequently, we expect that protection against Borrelia would require annual prophylaxis with TNX-4800.

    About Monoclonal Antibody Prophylaxis
    Two long-acting monoclonal antibody products10,11 have won FDA approval for prophylaxis against respiratory syncytial virus (RSV). AstraZeneca (in partnership with Sanofi) markets Beyfortus™ (nirsevimab) and Merck markets Enflonsia™ (clesrovimab).

    Tonix Pharmaceuticals Holding Corp.*
    Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix markets FDA-approved TONMYATM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. TONMYA is the first new prescription medicine approved by the FDA for fibromyalgia in more than 15 years. TONMYA was investigated as TNX-102 SL. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Tonix’s development portfolio* is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a Phase 2- ready Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome and expected to start a potential pivotal Phase 2 study in 2026. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a Phase 2- ready long-acting humanized monoclonal antibody for the seasonal prevention of Lyme disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md
    * 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.

    Citations

    1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.

    2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.

    3Cavaleri M, et al.. Biologicals. 2024. 85:101745.

    4Abo YN, et al.. Lancet Infect Dis. 2023. 23(12):e533-e546.

    5Ramanathan R, et al.. Vaccine. 2019 Jul 18;37(31):4256-4261.

    6Comstedt P, et al. Vaccine. 2015 33(44):5982-8.

    7Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn over concerns about an increased risk of autoimmune arthritis triggered by molecular mimicry, particularly in HLADRB1*0401 (“DR4+”) individuals. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. doi: 10.1017/S0950268806007096. Epub 2006 Aug 8. PMID: 16893489; PMCID: PMC2870557.

    8Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773. doi: 10.1093/cid/ciz872. PMID: 31620776; PMCID: PMC7155782.

    9National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.

    10May 29, 2025. Sanofi Press Release. “Beyfortus public health advantage bolstered by first real-world comparison of infant vs maternal RSV immunization programs.” https://bit.ly/40DeJGf

    11June 9, 2025. Merck Press Release. “U.S. FDA Approves Merck’s ENFLONSIA™ (clesrovimab-cfor) for Prevention of Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease in Infants Born During or Entering Their First RSV Season” https://bit.ly/4kkXDE8.

    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. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. 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
    Mary Ann Ondish
    Tonix Pharmaceuticals
    maryann.ondish@tonixpharma.com

    Ray Jordan 
    Putnam Insights 
    ray@putnaminsights.com 
     

    INDICATION
    TONMYA is indicated for the treatment of fibromyalgia in adults.

    CONTRAINDICATIONS
    TONMYA is contraindicated:
    In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected.
    With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs.

    During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure.
    In patients with hyperthyroidism.

    WARNINGS AND PRECAUTIONS
    Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy.

    Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases.
    Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures.

    Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs.

    CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities.
    Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur.

    ADVERSE REACTIONS
    The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer.

    DRUG INTERACTIONS

    MAO inhibitors: Life-threatening interactions may occur.

    Other serotonergic drugs: Serotonin syndrome has been reported.

    CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced.

    Tramadol: Seizure risk may be enhanced.
    Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked.

    USE IN SPECIFIC POPULATIONS
    Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED).

    Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition.

    Pediatric use: The safety and effectiveness of TONMYA have not been established.
    Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

    Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions.

    Please see additional safety information in the full Prescribing Information.
    To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    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.

    This press release and further information about Tonix can be found at www.tonixpharma.com.

    Source: Tonix Pharmaceuticals Holding Corp.

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  • Water’s Age and What It Can Tell Us

    Water’s Age and What It Can Tell Us

    When it rains, what happens to the water once it enters the soil? Does the new precipitation mix with all of the water that was already there? In their recent paper in Water Resources Research, Department of Natural Resources and the Environment Ph.D. student Joshua Snarski and assistant professor James Knighton show the answer is more complicated than previously assumed, but knowing the age of water gives a more accurate picture.

    Hydrologists use models to simulate what is happening in natural systems. Since hydrologic processes are complex, researchers need to make assumptions about some aspects, such as how water mixes within the soil profile. Though previous hydrologic research is focused on the amount and timing of precipitation, Snarski says shifting the focus to the age of water within the soil profile can reveal more about what is happening beneath the surface.

    For this project, the researchers determined the age of water in the soil by looking at the stable water isotope compositions of soil water samples through time. Stable water isotopes are naturally abundant in the environment and do not interact with other elements within the system, Snarski explains, which makes them powerful tracers. Each rainstorm releases water with a unique isotope signature, allowing each precipitation event to be tracked.

    Snarski collected water and soil samples in the watershed surrounding an agricultural field for one year and then calibrated two models to test a common assumption used in hydrological models. (Contributed photo)

    “Precipitation acts as water inputs to the soil and assigning these ‘new’ water inputs with an age of zero days allows us to ‘start the clock’ on the soil water aging,” says Snarski. “We collect precipitation and soil water samples to create a record of the volume and isotope signature of both the new water entering the soil and the existing water within the soil.”

    The researchers use these two water records to estimate the age of water in the soil profile over time. If you imagine a drop of rain traveling down through layers of soil, knowing the age of that water indicates its pace of movement, and that can provide insight into how water is stored within and released from soils. This information is especially crucial in agricultural settings, as farmers need to decide when and how much fertilizer to apply to fields to support crop growth.

    The researchers focused on agricultural fields during the growing season, Snarski explains, which experience the most fertilizer applications and the dryest soil conditions, due to less precipitation and more water uptake by plants. This combination can lead to high concentrations of dissolved compounds in the soil water.

    “When we see young water in deeper soil layers, we know that water is moving quickly and carrying with it dissolvable compounds, such as nutrients and pollutants,” says Snarski. “If dissolved nutrients move too quickly through the rooting zone, crops can’t access them, and they become a contamination risk for groundwater and surface waters. While fertilizers help farmers produce high crop yields, they pose a potential risk to nearby waterways. If excessive amounts of nutrients are quickly flushed to groundwater or transported with surface runoff, they can enter waterways and lead to eutrophication and hypoxia.”

    Next, the researchers calibrated two hydrological models to their soil water volume and isotope tracing data to test the assumption that soil water mixes fully. The first model assumed new water mixed fully with old water in each soil layer, while the second model allowed new water to bypass old water under certain conditions.

    “The second model separates the soil profile into two groups: small and large soil pores. Basically, the small pores hold water under high tension, but can be drained by plant water uptake, while the large pores can replenish the small pores or percolate to deeper soil layers,” says Snarski. “This simple separation of the soil by pore size allows for younger water in the large pores to bypass older water in the small pores.”

    The full mixing model estimated that the average age of water leaving the rooting zone in the mid-summer months was between 35 and 40 days old. This was a big difference to the model that considered pore size, which estimated that the age of water leaving the rooting zone was 10 to 15 days old. The collected soil water volume and water isotope data indicated that the second model was more accurate and better reflected conditions in the field, says Snarski. The results indicate that young water can bypass older water and that full mixing assumptions need to be reconsidered in hydrologic models. It also emphasized the importance of tracer data along with the volume of water.

    “Because we have this extra level of information, the concentration of stable water isotopes, we were able to estimate the age of water through the profile,” says Snarski. “If we were just measuring the amount of water in the soil, we wouldn’t know how long it’s been there, what pathways it traveled along, and which other sources of water its mixed with.”

    A long metal instrument used for sampling soil lays next to a hole in dug into the soil in an agricultural field.
    Snarski collected soil water samples and then analyzed the isotopes to study both the new and existing water in the soil. (Contributed photo)

    Snarski was surprised by how quickly the water was flowing through the rooting zone. This means that dissolved nutrients applied just before or during the summer may only be accessible to crops for between one to two weeks before entering deeper soils. This is a big problem not only in terms of crop growth and fertilizer costs, but also presents a concern for drinking water contamination. Knowing how water flows through the soil is an important detail that can help make agricultural practices more efficient, and it can be used to improve hydrologic models. This work also illustrates the nuances in effective modeling, Snarski explains.

    “George Box put it well when he said all models are wrong, but some are useful. To make models more realistic, you must account for more processes, which quickly adds complexity. More complex models require more input data and a more experienced modeler to use them,” says Snarski. “So, it comes down to a cost-benefit analysis. Does the improvement in the modeling results outweigh the cost of the added complexity? In our case, our second model has a more complex soil profile framework, but it better simulates soil water movement in the field and updates our understanding of how quickly water leaves the rooting zone.”

    Snarski is now looking at what other factors influence these dynamic processes.

    “After controlling for soil type, landscape position, and climate conditions, we are looking at whether soil management in different crop fields effects the water ages through the soil profile,” says Snarski. “If we see similar water ages across the various crop fields, crop type and soil management practices likely have a small effect on soil water movement. If we see large differences in the soil water ages, we will need to consider incorporating these factors into future models.”

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