Gyre Pharmaceuticals completed a Pre-NDA meeting with China’s CDE, which agreed that the existing Phase 3 clinical data support a conditional approval filing for Hydronidone and priority review eligibility, subject to formal approval.
Gyre Pharmaceuticals plans to submit an NDA in the first half of 2026 and conduct a confirmatory clinical trial to support full approval in China.
SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (Gyre or the Company) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic disease, today announced that its majority-owned subsidiary in China, Gyre Pharmaceuticals Co., Ltd. (Gyre Pharmaceuticals), completed a Pre–New Drug Application (Pre-NDA) communication meeting with the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) regarding Hydronidone, the Company’s first-in-class anti-fibrotic therapy.
During the meeting, Gyre Pharmaceuticals and the CDE reached consensus that existing Phase 3 clinical data for Hydronidone, based on histologic improvement in liver fibrosis as measured by the Ishak fibrosis score, are generally supportive of submission of a conditional approval NDA for the treatment of chronic hepatitis B (CHB)-associated liver fibrosis, including early (compensated) cirrhosis. The CDE further indicated that Hydronidone meets the criteria for inclusion in China’s Priority Review and Approval Program for Innovative Drugs, subject to formal filing, acceptance and regulatory review.
The NMPA previously granted Hydronidone Breakthrough Therapy Designation in March 2021, recognizing its potential to address a serious condition with significant unmet medical need. This designation supports eligibility for priority review, which is intended to facilitate an accelerated regulatory review process for innovative therapies.
As previously disclosed on May 22, 2025, Gyre reported topline results from its Phase 3 trial in CHB-associated liver fibrosis demonstrating that Hydronidone met its primary endpoint, with 52.85% of treated patients achieving ≥1-stage fibrosis regression at Week 52, compared with 29.84% in the placebo group (p=0.0002), based on centralized, blinded Ishak histologic assessment. The trial also achieved a key secondary endpoint evaluating improvement in liver inflammation without fibrosis progression and demonstrated a favorable safety profile consistent with prior clinical experience.
As part of the agreed regulatory pathway, the Company plans to conduct an additional confirmatory clinical trial (referred to as a Phase 3c trial in China) designed to evaluate liver-related clinical outcomes to support potential conversion from conditional approval to regular approval.
The Company currently expects to submit an NDA for conditional approval of Hydronidone in the first half of 2026, subject to final data readiness and applicable regulatory procedures.
“Hydronidone addresses a significant unmet medical need in patients with CHB-associated liver fibrosis, for whom there are currently no approved anti-fibrotic therapies,” said Ping Zhang, Interim Chief Executive Officer of Gyre. “We are encouraged by the positive and constructive Pre-NDA dialogue with the CDE and the alignment achieved on a clear regulatory pathway. This milestone reflects the strength of our Phase 3 clinical data and supports our plans to advance Hydronidone toward conditional approval in China.”
About Hydronidone
Hydronidone is a novel, orally administered anti-fibrotic agent designed to target key liver fibrosis pathways. It attenuates hepatic stellate cell activation and fibrogenesis, at least in part, by suppressing TGF-β1-induced signal transduction, including reduced p38γ phosphorylation and upregulated Smad7 expression. This upregulation of Smad7 subsequently leads to downregulation of TGF-βRI and inhibition of Smad2/3 activation, thereby disrupting canonical TGF-β/Smad signaling and reducing fibrotic gene expression in HSCs.
The drug has completed Phase 3 clinical evaluation in China for CHB-associated liver fibrosis, including early (compensated) cirrhosis, and is being evaluated for its potential applicability across additional fibrotic diseases in region-specific development programs.
About the CHB Fibrosis Market in China
CHB-associated liver fibrosis represents a significant unmet medical need in China. According to China’s national hepatitis B serological survey and internal epidemiological modeling, it is estimated that 60–70 million people in China are infected with hepatitis B virus, of whom approximately 14.7 million are diagnosed. Among these patients, an estimated 2.6 million have diagnosed, compensated, clinically significant liver fibrosis (F2–F4), excluding decompensated cirrhosis, and may be eligible for anti-fibrotic intervention.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals’ pipeline includes Hydronidone, a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. Hydronidone received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of the third quarter of 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of Hydronidone for liver fibrosis including MASH in the U.S. Gyre’s strategy builds on its experience in mechanistic studies using MASH rodent models and clinical studies in CHB-induced liver fibrosis. In the PRC, Gyre is advancing a broad pipeline through its indirect controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, F528, and F230.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and the timing of expected clinical readouts and regulatory filings, including the anticipated timing of the filing of Gyre’s NDA with the NMPA for the conditional approval of Hydronidone for the treatment of CHB-associated liver fibrosis and early cirrhosis and the initiation of the confirmatory Phase 3c clinical trial of Hydronidone to support full approval in China. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital; supply chain and distribution delays and challenges. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
For Investors: David Zhang, Chief Business Officer [email protected]
CALGARY AB, Jan. 2, 2026 /CNW/ – InPlay Oil Corp. (TSX: IPO) (OTCQX: IPOOF) (“InPlay” or the “Company”) is pleased to confirm that its Board of Directors has declared a monthly cash dividend of $0.09 per common share payable on January 30, 2026, to shareholders of record at the close of business on January 15, 2026. The monthly cash dividend is expected to be designated as an “eligible dividend” for Canadian federal and provincial income tax purposes.
About InPlay Oil Corp.
InPlay is a junior oil and gas exploration and production company with operations in Alberta focused on light oil production. The company operates long-lived, low-decline properties with drilling development and enhanced oil recovery potential as well as undeveloped lands with exploration possibilities. The common shares of InPlay trade on the Toronto Stock Exchange under the symbol IPO and the OTCQX Exchange under the symbol IPOOF.
For further information please contact: Doug Bartole, President and Chief Executive Officer, InPlay Oil Corp., Telephone: (587) 955-0632; Darren Dittmer, Chief Financial Officer, InPlay Oil Corp., Telephone: (587) 955-0634
Toronto, Ontario–(Newsfile Corp. – January 2, 2026) – Aurania Resources Ltd. (TSXV: ARU) (OTCQB: AUIAF) (FSE: 20Q) (“Aurania” or the “Company”) announces that its Board of Directors have agreed to receive their quarterly director fees in the form of stock options in lieu of cash for the fourth quarter of 2025. For more information, see press releases dated March 31, 2025, July 1, 2025 and October 1, 2025.
On December 31, 2025, each director was granted 34,500 stock options at an exercise price of $0.175 in lieu of their director fees for the fourth quarter of 2025. An aggregate of 138,000 stock options was granted. All such stock options will be exercisable for a period of three years from the date of grant and vested immediately upon grant. In the event a director intends to exercise such stock options, such director shall be solely responsible for paying the entirety of the exercise price.
About Aurania Aurania is a mineral exploration company engaged in the identification, evaluation, acquisition, and exploration of mineral property interests, with a focus on precious metals and critical energy in Europe and abroad.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Vancouver, British Columbia–(Newsfile Corp. – December 29, 2025) – Nicola Mining Inc. (TSXV: NIM) (the “Company” or “Nicola Mining“) is pleased to announce an additional investment from Ocean Partners UK Limited[1] (“Ocean Partners“), which has agreed to participate in a strategic non-brokered private investment of $1,000,000 to strengthen the Company’s balance sheet as it prepares to uplist onto NASDAQ in Q1 of 2026.
The Company will issue 1,111,112 units (each a “Unit“) at a price of $0.90 per Unit for gross proceeds of up to $1,000,000 (the “Offering“).
Each Unit will consist of one common share of the Company (each, a “Share“) and one transferable common share purchase warrant (each, a “Warrant“). Each Warrant will entitle the holder to purchase one additional Share at a price of $1.10 per Share for a period of three years following the closing of the Offering (the “Closing“). The expiry of the Warrants may be accelerated if the closing price of the Company’s common shares on the TSX Venture Exchange (the “Exchange”) is $1.70 or greater for a minimum of ten consecutive trading days, provided that a notice of acceleration is issued in accordance with the terms of the Warrants.
All securities issued in connection with the Offering will be subject to a statutory holding period expiring four months and one day after closing of the Offering. Completion of the Offering is subject to the approval of the Exchange. Any participation by insiders in the Offering will constitute a related party transaction under Multilateral Instrument 61-101 – Protection of Minority Security Holders in Special Transactions (“MI 61-101”) but is expected to be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101.
The aggregate gross proceeds from the sale of the Offering will be used for general working capital.
None of the securities sold in connection with the Offering will be registered under the United States Securities Act of 1933, as amended, and no such securities may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. This news release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
Strategic Advisor – Mr. Rahim Kassim-Lakha of Blue Sail Capital
Nicola is also pleased to announce the appointment of Rahim Kassim-Lakha, founder and CEO of Blue Sail Capital, as Strategic Advisor. With nearly 30 years of investing in global i capital markets and M&A experience, Mr. Kassim-Lakha has a proven track record in raising capital and structuring transactions. He has held senior roles at Fidelity Capital and U.S. Global Investors, where he managed over US$1 billion across three award-winning funds. As Strategic Advisor he will provide guidance on capital markets strategy and corporate development opportunities as Nicola advances its projects.
About Nicola Mining
Nicola Mining Inc. is a junior mining company listed on the Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.
The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which is a fully-permitted high grade silver mine and includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
[1] Ocean Partners operates in several countries throughout the world. Ocean Partners maintains a strong global network of relationships and contacts in the base metal mining and smelting sector.
Earthvision Bio, is currently developing and commercializing its line of sustainable products developed by Dr. Gordon Moore, the founder of Intel, and Dr. Hans Franke, ex-chairman for Chevron Europe
Nutriband Inc. Shareholders will retain 10% of the shareholding in Earth Vision Bio following the acquisition
The expected closing date for the transaction is Dec 31, 2025.
Orlando, Fla. – Dec 29, 2025 – Nutriband Inc. (NASDAQ: NTRB) (NASDAQ: NTRBW), today announced that it has signed an agreement to sell a 90% interest in its subsidiary Pocono Pharmaceutical for $5M USD to EarthVision Bio.
Earthvision Bio has developed and are commercializing a new category of sustainable products created by Dr. Gordon Moore, the founder of Intel (NASDAQ: INTC), and Dr. Hans Franke, who was board chairman for Chevron Europe. The Company has developed a sustainable way to replace plastic, molded fiber, wood, and paper products with Earth-friendly alternatives.
Nutriband Inc. Shareholders will retain 10% of the shareholding in Earth Vision Bio following the acquisition.
Nutriband inc. will use the proceeds from the sale of Pocono Pharma towards its continued development of AVERSA Fentanyl which has the potential to be the world’s first and only abuse-deterrent opioid patch designed to deter the abuse and misuse and reduce the risk of accidental exposure of transdermal fentanyl patches. AVERSA Fentanyl has the potential to reach annual US sales of $80 million to $200 million.
About AVERSA™ Abuse-Deterrent Transdermal Technology
Nutriband’s AVERSA™ abuse-deterrent transdermal technology incorporates aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, including opioids and stimulant drugs, while making sure that these drugs remain accessible to those patients who really need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, China, Canada, Mexico, and Australia.
About Nutriband Inc.
We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse-deterrent fentanyl patch incorporating our AVERSA™ abuse-deterrent technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.
The Company’s website is www.nutriband.com. Any material contained in or derived from
Forward-Looking Statements
Certain statements contained in this press release, including, without limitation, statements containing the words ‘’believes,” “anticipates,” “expects” and words of similar import, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company’s actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company’s ability to develop its proposed abuse-deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company’s business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s periodic and current reports on Form 10-K, Forms 10-Q and 8-K and the Company’s other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.
PONTE VEDRA, FL / ACCESS Newswire / December 29, 2025 / Every industry has its forgotten corners. In anticoagulation, those corners turned into entire neighborhoods. For years, the field centered itself around convenience drugs built for broad populations and clean commercial lines. Warfarin stayed because it always had. DOACs (direct oral anticoagulants) rose in use because they were easier to manage. The patients who were harder to serve, the ones with unstable renal function or dangerous immune responses, got pushed to the edges of the conversation.
Cadrenal Therapeutics (NASDAQ:CVKD) did not follow the herd. It walked straight into the clinical territory everyone else avoided. Not because it was simple. Not because it was fashionable. But because improving outcomes for the most fragile patients is where real therapeutic change begins. The future of anticoagulation will not be won by a slightly more polished version of what already exists. It will be won by companies willing to rebuild the pieces that Big Pharma stopped trying to fix.
That is where Cadrenal stands today. The company is not chasing the old model. It is reconstructing the parts of anticoagulation where the stakes are the highest and the options are the weakest. It is doing it with intention, with discipline, and with a portfolio engineered to solve the hardest problems first. That is how you build something lasting in a field that has not changed meaningfully in decades.
Tecarfarin Sets the Foundation for a Different Kind of Platform
Cadrenal’s Phase 3-ready lead asset, tecarfarin, makes the company’s strategy instantly clear. The drug is designed to serve patients who fall outside the tolerances of traditional anticoagulation. End-stage kidney disease. Dialysis transitions. Complex cardiac burdens that magnify every downside of existing drugs. These are not the easy cases. They are the cases where outcomes hinge on control, predictability, and the ability to adjust therapy without destabilizing the entire system.
Tecarfarin was built precisely for that environment. It is engineered to offer stability where warfarin wobbles. It maintains therapeutic levels without the wild swings that plague standard vitamin K antagonists. It avoids the renal clearance issues that make DOACs dangerous for kidney-impaired patients. And it retains reversibility, one of the most clinically valuable yet commercially underappreciated traits in anticoagulation.
This is not a niche convenience drug. It is the cornerstone of a platform built for patients who cannot rely on yesterday’s tools. Tecarfarin is what happens when a company decides to re-engineer the roots of a category rather than dress up the branches.
The eXIthera XIa Acquisition Expanded Cadrenal From Chronic to Acute Care
The company’s next major move signaled its intent to play across the full spectrum of anticoagulation. Cadrenal acquired a Factor XIa inhibitor portfolio from eXIthera, giving it a second mechanistic approach that fits squarely into acute hospital care. Factor XIa is one of the most promising targets in modern hematology because it reduces clot formation without triggering the same bleeding penalties clinicians struggle with today.
This acquisition expanded Cadrenal’s relevance beyond chronic conditions and into the point-of-care environment, where hospitals need safer and more predictable anticoagulation. A single admission involving a bleeding complication or a clot formation event can cost tens of thousands of dollars and derail treatment plans. Hospitals know this. Physicians know this. Cadrenal clearly knows it too.
By integrating Factor XIa into its strategy, the company now spans both sides of the anticoagulation lifecycle. Tecarfarin stabilizes long-term risk. Factor XIa manages acute risk. Very few small companies get that kind of mechanistic breadth. Cadrenal built it in a single step.
VLX-1005 Pushed Cadrenal Into High-Stakes Immune-Mediated Territory
Then Cadrenal raised the stakes again. The company acquired VLX-1005, a first-in-class 12-LOX inhibitor in Phase 2 development for heparin-induced thrombocytopenia. HIT is one of the most dangerous complications in hospital medicine. It turns a routine anticoagulant like heparin into a trigger for catastrophic clotting and platelet collapse. Doctors do not get much time to react once HIT is in motion.
VLX-1005 comes with Orphan Drug and Fast Track designations, which immediately elevate its strategic value. This program moves Cadrenal into an area where treatment options are scarce, the stakes are immediate, and even incremental improvements matter. It also proves that the company is building a portfolio, not a single drug story.
With VLX-1005 in the mix, Cadrenal now sits on three distinct scientific pillars. Vitamin K antagonism with tecarfarin. Factor XIa inhibition for acute care. 12-LOX inhibition for immune-mediated thrombosis. This is not an accidental collection of assets. It is a purpose-built response to the biggest failures of today’s anticoagulation toolkit.
A Pipeline Built for the Problems That Actually Matter
Cadrenal is rebuilding the parts of anticoagulation that the rest of the industry quietly accepted as unsolvable. It focuses on the patients who create the most clinical and economic strain. It is expanding across chronic, acute, and immune-mediated conditions without drifting away from its central theme.
The company does not look like a microcap when you study the configuration of its pipeline. It looks like a specialty anticoagulation house in its early chapters. Investors will eventually catch up, but the company is not waiting for them. The work is already underway. The blueprint is already visible. And the parts of anticoagulation that everyone else has given up on are finally being rebuilt.
About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
Accuracy & Disclosure Statement: Hawk Point Media Group, LLC (HPM) has been retained by IR Agency, Inc. to provide press releases, editorial insights, and digital media production for Cadrenal Therapeutics. This content is sponsored. For services rendered from December 12, 2025 through December 16, 2025, extended to December 31, 2025, HPM has been compensated ten thousand dollars (USD) via wire transfer for content creation and syndication related to Cadrenal Therapeutics. The information contained herein is based on sources believed to be accurate and reliable at the time of creation, including publicly available filings, company disclosures, and direct website content. This material is provided for informational purposes only and should not be interpreted as investment advice, a recommendation, or an offer to buy or sell any security.
At the time of publication, HPM does not own, buy, sell, or trade securities of the companies covered. However, individuals or organizations that have retained HPM may hold shares of Cadrenal Therapeutics and may sell those shares during the coverage period. Such sales could place downward pressure on the stock price and result in financial loss for investors.
Any reproduction, redistribution, or syndication of this content must include this disclosure in full. This statement is provided in accordance with Section 17(b) of the Securities Act of 1933, the Federal Trade Commission’s Endorsement Guides, and other applicable laws governing sponsored communications and paid investor content.
SAN DIEGO, Dec. 29, 2025 (GLOBE NEWSWIRE) — Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS), a leader in defense, national security and global markets, announced today that it has recently received approximately $30 million in Air Defense and C5ISR system national-security-related, military-grade custom hardware production contracts. Kratos is an industry leader in the development, engineering, design, and large-scale production of military-grade hardware and integrated systems for missile, radar, counter-UAS, hypersonic, directed energy, satellite communication, and other complex systems. Work performed under the recent contract awards will be performed in secure Kratos manufacturing facilities.
Tom Mills, President of Kratos’ C5ISR Division, said, “Our entire team is honored to have our customers’ confidence in our ability to engage early in the systems’ design phase to collaborate with our customers on system-level engineering and design, provide highly engineered custom systems and solutions, large-scale manufacturing, at an affordable cost, for these urgent, relevant, and mission critical systems. Kratos is the recognized industry leader in delivering military-grade hardware and systems in direct support of America’s National Security requirements.”
Eric DeMarco, President and CEO of Kratos, said, “Delivering relevant, military-grade hardware on time, on schedule, and that works every time is hard, and Kratos’ demonstrated capability to continuously do so is a differentiator for our Company to our customers and partners. Kratos is currently in high volume, mass production on multiple hypersonic, counter-UAS, missile, radar and other systems, and we are proud to be the clear industry leader in our mil-spec hardware areas of expertise.”
Due to competitive, security related and other considerations, no additional information will be provided.
About Kratos Defense & Security Solutions Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, advanced vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter. For more information, visit www.KratosDefense.com.
Notice Regarding Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.
Carriage Deals With Free TV France, HOT Israel and Primetel Cyprus, Along With a Partnership in Ukraine, Extend Newsmax’s Reach Across Europe and the Mid-East
BOCA RATON, FLORIDA / ACCESS Newswire / December 29, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) through its subsidiary Newsmax Broadcasting, today announced a series of multi-year distribution agreements with major TV distributors across Europe and the eastern Mediterranean. These partnerships with Free TV in France, HOT in Israel and Primetel in Cyprus will make the Newsmax channel available to millions of new households and demonstrates the Company’s commitment to delivering independent U.S.-based news to international audiences.
In addition, Newsmax has entered into a brand license agreement to launch early next year a local channel, “Newsmax Ukraine”, available in the Ukrainian language.
New carriage and brand license agreements
Free TV (France) – Free TV, one of France’s leading telecommunications providers, has launched Newsmax on channel 351, reaching approximately 3.5 million households. This partnership strengthens Newsmax’s presence in Western Europe and offers French viewers 24/7 access to both U.S. and global news.
HOT (Israel) – Newsmax is now available in English on channel 204 through HOT Israel, a major telecommunications and pay TV operator. The launch reaches more than 200,000 subscribers and expands Newsmax’s footprint in a key U.S.-ally market, providing Israeli audiences with access to breaking news, political analysis and cultural coverage.
Primetel (Cyprus) – Newsmax has debuted on channel 241 via Primetel, a leading IPTV and telecom provider in Cyprus. Primetel subscribers can access Newsmax’s live news, interviews and talk programming, further strengthening Newsmax’s presence in the eastern Mediterranean region.
Newsmax Ukraine – Newsmax has signed a brand license agreement for the launch of Newsmax Ukraine, a localized news channel expected to go live in the first half of 2026. The channel will operate under the Newsmax brand and editorial framework, marking an important step in the Company’s Eastern European growth strategy and its commitment to expanding access to international news in the region.
Newsmax is now available in more than 100 countries across five continents. According to Nielsen, Newsmax is the fourth highest-rated cable news network in the United States, reaching over 40 million Americans through its television channel, streaming services and digital platforms.
About Newsmax
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 50 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches over 22 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
Forward-Looking Statements This communication contains forward-looking statements. From time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Forward-looking statements can be identified by those that are not historical in nature. The forward-looking statements discussed in this communication and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us. Newsmax does not guarantee future results, performance or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy or completeness of any of these forward-looking statements. Forward-looking statements should not be relied upon as predictions of future events. We are under no duty to update any of these forward-looking statements after the date of this communication to conform our prior statements to actual results or revised expectations, and we do not intend to do so. Factors that may cause actual results to differ materially from current expectations include various factors, including but not limited to the factors set forth in the sections entitled “Risk Factors” in Newsmax’s Annual Report on Form 10-K for the twelve months ended December 31, 2024, Newsmax’s Quarterly Report on Form 10-Q for the three months ended March 31, 2025, and other filings Newsmax makes with the Securities and Exchange Commission. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. Undue reliance should not be placed on forward-looking statements in this communication, which speak only as of the date they are made and are qualified in their entirety by reference to the cautionary statements herein.
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 [email protected].
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.
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.
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.
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.
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.
Saguenay, Quebec–(Newsfile Corp. – December 29, 2025) – First Phosphate Corp. (CSE: PHOS) (OTCQX: FRSPF) (FSE: KD0) (“First Phosphate” or the “Company“) is pleased to announce that, effective December 19, 2025, its common shares have been added to the CSE25 Index as part of the Canadian Securities Exchange’s (“CSE”) quarterly index rebalancing.
The CSE 25 Index is comprised of the 25 leading companies listed on the CSE, selected based on market capitalization and liquidity criteria. Inclusion in the index increases visibility among institutional and retail investors and results in broader exposure through index-linked investment products and mandates.
“Inclusion in the CSE25 reflects the growing recognition of First Phosphate’s strategic positioning within the North American critical minerals and energy transition ecosystem,” said John Passalacqua, CEO of First Phosphate. “As lithium iron phosphate (“LFP”) batteries are now the dominant chemistry for grid-scale energy storage, data centers and mobility applications, investors are increasingly focused on secure, domestic sources of high-purity phosphate and our differentiated, vertically integrated platform to serve that demand.”
First Phosphate is advancing a rare, high-purity igneous phosphate resource in Saguenay-Lac-Saint-Jean, Quebec, with the objective of supplying high purity phosphate-based downstream materials required for LFP batteries. The Company’s mine-to-market strategy is focused on onshoring critical battery materials, reducing supply chain risk, and supporting North American energy security.
The high-purity phosphoric acid and iron powder for these LFP 18650 battery cells was produced using rare igneous anorthosite rock extracted from the Company’s Bégin-Lamarche property in Saguenay-Lac-Saint-Jean, Quebec.
First Phosphate (CSE: PHOS) (OTCQX: FRSPF) (FSE: KD0) is a mineral exploration, development and cleantech company dedicated to building and onshoring a vertically integrated mine-to-market lithium iron phosphate (LFP) battery supply chain for North America. Target markets include energy storage, data centers, robotics, mobility and national security. First Phosphate’s flagship Bégin-Lamarche Property in Saguenay-Lac-Saint-Jean, Quebec, Canada is a North American rare igneous phosphate resource yielding high-purity phosphate with minimal impurities.
Forward-Looking Information and Cautionary Statements
This release includes certain statements that may be deemed “forward-looking information”. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. In particular, this press release contains forward-looking information relating to, among other things: increased visibility among institutional and retail investors and broader exposure through index-linked investment products and mandates resulting from inclusion in the CSE25 index; supplying high purity phosphate-based downstream materials required for LFP batteries; the Company’s plans for onshoring critical battery materials, reducing supply chain risk, and supporting North American energy security; and the Company’s plans for building and onshoring a vertically integrated mine-to-market LFP battery supply chain for North America. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those forward-looking statements. Factors that could cause actual results to differ materially from those in forward-looking statements include development and exploration successes, continued availability of capital and financing, and general economic, market or business conditions. These statements are based on a number of assumptions including, among other things, assumptions regarding general business and economic conditions; there being no significant disruptions affecting the activities of the Company or inability to access required project inputs; permitting and development of the projects being consistent with the Company’s expectations; the accuracy of the current mineral resource estimates for the Company and results of metallurgical testing; certain price assumptions for P2O5 and Fe2O3; inflation and prices for Company project inputs being approximately consistent with anticipated levels; the Company’s relationship with First Nations and other Indigenous parties remaining consistent with the Company’s expectations; the Company’s relationship with other third party partners and suppliers remaining consistent with the Company’s expectations; and government relations and actions being consistent with Company expectations. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. The Company does not assume any obligation to update or revise its forward-looking statements, whether because of new information, future events or otherwise, except as required by applicable law. All forward-looking information contained in this release is qualified by these cautionary statements.
New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission
LOS ALTOS, Calif., Dec. 29, 2025 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it has resubmitted its 505(b)(2) New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
“Our original third-party manufacturing vendor has made significant progress toward regaining FDA compliance, allowing us to resubmit the OLC NDA as planned,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “With a cash runway into 2027, we are well-positioned to complete the regulatory approval process for OLC so we can prepare to bring this important treatment option to dialysis patients with hyperphosphatemia as soon as possible.”
The NDA for OLC was resubmitted based on continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed these milestones during a Type A meeting with the FDA in September 2025, which was held to obtain feedback and alignment on resolving the single deficiency identified in the Company’s Complete Response Letter (CRL) related to the compliance status of the vendor. No additional issues were raised by the FDA. Following receipt of the CRL in June 2025, European Union regulatory authorities inspected the original third-party manufacturing vendor and identified no deficiencies.
The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review within 30 days of submission, and completion of submission review within 6 months.
About Oxylanthanum Carbonate (OLC) OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden.
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
About Hyperphosphatemia Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.
About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information about Unicycive, visit Unicycive.com and follow us on LinkedIn and X.
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 using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; our need to raise substantial additional capital in the future to fund our continuing operations and the development and commercialization of our current product candidates and future product candidates; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; risks related to delays in obtaining or failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; and our failure, or the failure of our third-party manufacturers, or their subcontractors, to comply with cGMPs or other applicable regulations, which could result in sanctions being imposed on us or the manufacturers, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could adversely affect supplies of our product candidates and harm our business and results of operations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Andy Wiederhorn Appointed Chief Executive Officer; Roger Gondek to Assume Twin Peaks President Role
DALLAS, Dec. 29, 2025 (GLOBE NEWSWIRE) — Twin Hospitality Group Inc. (Nasdaq: TWNP), the parent company of Twin Peaks Restaurant, today announced the appointment of Andy Wiederhorn as Chief Executive Officer, effective immediately, following the termination of Chief Executive Officer Kim Boerema. Additionally, Roger Gondek, currently Chief Operating Officer of Twin Peaks Restaurant, will also assume the role of President of Twin Peaks Restaurant while continuing in his COO responsibilities.
Wiederhorn, who was integral in spinning out Twin Peaks and Smokey Bones into Twin Hospitality Group Inc., has served as Chairman of the Board since August 2025. In this role, he has worked closely with the leadership team to position the company for sustained growth and operational excellence. Gondek has served as Chief Operating Officer of Twin Peaks since 2017 and brings approximately 15 years of experience with the brand, including previous operations leadership roles with Twin Peaks’ largest franchisee.
“I’m pleased to take on the Chief Executive Officer role and continue to collaborate with Roger in his expanded capacity as President,” said Andy Wiederhorn, Chairman and Chief Executive Officer of Twin Hospitality Group. “We remain focused on driving key business initiatives forward, including streamlining operations and enhancing the guest experience. This leadership restructuring optimizes our resources while minimizing overhead, providing additional value as we work to restructure our debt and strengthen the company for long-term success.”
Twin Hospitality Group Inc. Twin Hospitality Group Inc. is a restaurant company that strategically develops and operates specialty casual dining restaurant concepts with a goal to redefine the casual dining category with its experiential driven brands. For more information, visit https://ir.twinpeaksrestaurant.com/.
About Twin Peaks Founded in 2005 in the Dallas suburb of Lewisville, Twin Peaks has 114 locations in the U.S. and Mexico. Twin Peaks is the ultimate sports lodge featuring made-from-scratch food and the coldest beer in the business, surrounded by scenic views and wall-to-wall TVs. At every Twin Peaks, guests are immediately welcomed by a friendly Twin Peaks Girl and served up a menu made for MVPs. From its smashed and seared-to-order burgers to its in-house smoked brisket and wings, guests can expect menu items that satisfy every appetite. To learn more about franchise opportunities, visit twinpeaksfranchise.com. For more information, visit twinpeaksrestaurant.com.
Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company’s future operating performance. Forward-looking statements reflect the expectations of management concerning the future and are subject to significant business, economic and competitive risks, uncertainties, and contingencies. These factors are difficult to predict and beyond our control and could cause our actual results to differ materially from those expressed or implied in such forward-looking statements. We refer you to the documents that are filed from time to time by Twin Hospitality Group Inc. with the Securities and Exchange Commission, such as its reports on Form 10-K, Form 10-Q and Form 8-K, for a discussion of these and other factors. We undertake no obligation to update any forward-looking statement to reflect events or circumstances occurring after the date of this press release.
