Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Initiation. We are initiating equity research coverage on Twin Hospitality Group with an Outperform rating and $10 price target. Twin Hospitality is a franchisor and operator of two specialty casual dining restaurant concepts: Twin Peaks and Smokey Bones. The Company is a high-growth, asset light restaurant franchisor with a compelling franchisee value proposition, in our view. On January 29, 2025, parent company FAT Brands distributed approximately 5% of Twin Hospitality Class A shares to FAT Brands shareholders, bringing Twin Hospitality public.
A Premium Sports Bar Leader. Twin Hospitality currently operates approximately 115 Twin Peaks locations, consisting of 35 Company-owned and 80 franchised units. Twin Peaks offers a differentiated sports bar experience, from the lodge experience, to its signature 28-degree draft beer, a made-from-scratch menu, always-on wall-to-wall TVs, to the Twin Peaks Ambassadors, every customer receives an experience differentiated from the competition.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Graham Corporation designs, manufactures and sells critical equipment for the energy, defense and chemical/petrochemical industries. The Company designs and manufactures custom-engineered ejectors, vacuum pumping systems, surface condensers and vacuum systems. It is a nuclear code accredited fabrication and specialty machining company. It supplies components used inside reactor vessels and outside containment vessels of nuclear power facilities. Its equipment is found in applications, such as metal refining, pulp and paper processing, water heating, refrigeration, desalination, food processing, pharmaceutical, heating, ventilating and air conditioning. For the defense industry, its equipment is used in nuclear propulsion power systems for the United States Navy. The Company’s products are used in a range of industrial process applications in energy markets, including petroleum refining, defense, chemical and petrochemical processing, power generation/alternative energy and other.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
An Acquisition. Yesterday, after the market close, Graham announced the acquisition of certain specified assets of Xdot Bearing Technologies (“Xdot”), a specialized consulting, design, and engineering firm focused on foil bearing technology. While the acquisition price was not revealed, Graham noted Xdot has annual sales of approximately $1 million and is expected to be slightly accretive to the Company’s fiscal year 2026 GAAP net income.
Xdot. Xdot has developed and patented a breakthrough foil bearing design that delivers superior performance while lowering development and production costs. Xdot’s products are complementary to the existing product portfolio of Graham’s Barber-Nichols (BN) subsidiary and will expand capabilities within BN. Notably, Dr. Erik Swanson, Founder, President, and Chief Engineer of Xdot is a world renowned expert in foil bearing analysis, application, and fabrication and will join the BN team upon closing.
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
Minerva Neurosciences (Nasdaq: NERV) has put itself firmly back in the spotlight, announcing one of the largest small-cap biotech financings of 2025. The Massachusetts-based clinical-stage company will receive up to $200 million to fund a confirmatory Phase 3 trial and commercial launch preparation for roluperidone, a promising therapy targeting the often-overlooked negative symptoms in schizophrenia patients. The initial $80 million arrives up front, with further tranches contingent on study milestones, offering NERV investors rare clinical and regulatory visibility at a critical inflection point.
This private placement, due to close October 23, includes $80 million upfront through Series A Convertible Preferred Stock and up to $80 million more if Tranche A warrants are fully exercised, plus a potential $40 million linked to subsequent milestone events. The offering is led by Vivo Capital with support from several prominent healthcare investors, suggesting the market sees real value in roluperidone’s regulatory progress.
But unlike many small caps, which struggle with dilutive equity raises or uncertain funding, Minerva’s staged, milestone-driven deal structure means investors can track clinical and regulatory progress directly to additional capital inflows. Warrants are only unlocked if the trial meets its statistically significant 12-week endpoint, keeping capital efficiently aligned to risk.
Minerva has achieved a notable alignment with the FDA on its confirmatory trial protocol for roluperidone, targeting negative symptoms—a significant unmet need in schizophrenia treatment. Negative symptoms, such as social withdrawal or loss of motivation, often persist even with current antipsychotics, representing a billion-dollar market where no competitor is FDA-approved. Minerva’s confirmatory Phase 3 design will use a randomized double-blind, placebo-controlled format, tracking the PANSS Marder negative symptoms factor score as a primary endpoint over 12 weeks.
This clarity on regulatory requirements and a defined path for NDA resubmission is crucial for investors, lowering typical clinical-stage risk and increasing confidence in eventual market entry. The company has committed resources for trial expansion and is already preparing for a U.S. commercial launch, signaling an advanced state of readiness pending approval.
In addition to the funding, Minerva plans to strengthen its board with up to three new directors experienced in schizophrenia trials, further supporting robust clinical execution. Investors will also appoint a Scientific Advisory Board dedicated to trial oversight, ensuring best practices and direct accountability to stakeholders.
With shares already up over 150% for the year, Minerva now stakes its future on one pivotal readout. For small cap-focused investors, NERV offers rare transparency on trial financing, regulatory alignment, and near-term commercial prospects—key ingredients for outsized returns but also heightened binary risk typical of biotech.
As Minerva initiates its confirmatory Phase 3 trial and prepares for NDA resubmission, sector watchers will track not just headline efficacy results, but also enrollment metrics, board appointments, and potential warrant triggers. For investors tolerant of volatility and seeking direct exposure to major clinical milestones, Minerva’s fully funded path towards solving negative symptoms in schizophrenia could prove a defining bet in the 2025 biotech landscape.
In a move with broad implications for the future of global supply chains and the defence technology sector, President Donald Trump and Australian Prime Minister Anthony Albanese have signed a new agreement on critical minerals. This collaboration was unveiled at the White House on October 20, 2025, and establishes a formal partnership with a project pipeline that could reach $8.5 billion.
Though the White House described the agreement as a framework, officials in both countries confirmed immediate capital is forthcoming for key initiatives. Over the next six months alone, the agreement will facilitate joint investments of more than $3 billion, with Australia and the U.S. directly contributing at least $1 billion in the near term. Much of this funding will be deployed into advanced processing and mining projects focused on rare earths and other critical minerals essential for high-tech manufacturing and defence, including electric vehicles, robotics, and semiconductors.
The U.S. Export-Import Bank is prepared to offer at least $2.2 billion in letters of interest for project loans, which could unlock up to $5 billion in further investment. Alcoa and other major industrial players are already involved, with a particular emphasis on new rare earths separation facilities and a gallium refinery in Western Australia. The Pentagon is backing the gallium project, targeting a refinery output of 100 metric tons annually, a move that will significantly enhance non-Chinese supply for this vital semiconductor and electronics material.
This agreement comes as the global race to secure critical minerals intensifies. China continues to dominate rare earth processing and recently implemented strict export controls, escalating trade tensions with the U.S. and its allies. The new U.S.–Australia framework marks a decisive shift away from Chinese supply chain dependence and signals a new era of industrial cooperation between Western allies.
The market outlook is robust: rare earths and related minerals are used in everything from precision-guided missile systems to wind turbines and next-generation batteries. With rising geopolitical risk and acute supply chain vulnerabilities exposed, government-backed efforts like this one are set to redefine project financing and resource development models. The pipeline also includes a three-country venture involving the U.S., Australia, and Japan, integrating expertise and industrial capacity across the Pacific.
From the investor’s perspective, the partnership is about more than near-term capital flows. It reflects a “friend-shoring” philosophy, rerouting core inputs for modern industrial economies through trusted democratic partners. This is expected to benefit not only major participants like Alcoa but also small and micro-cap mining companies able to secure public or strategic backing for projects in Australia and allied regions. With the right execution, these upstream investments could set the stage for renewed growth and improved supply security throughout the clean energy and technology sectors
October 20, 2025 – Vancouver, Canada – Century Lithium Corp. (TSXV: LCE) (OTCQX: CYDVF) (Frankfurt: C1Z) (“Century Lithium” or “the Company”) is pleased to announce that the Company’s Lithium Extraction Facility (“Demonstration Plant”) in Amargosa Valley, Nevada, USA, has produced for its first time lithium hydroxide from lithium carbonate derived from the Company’s 100%-owned Angel Island lithium project, located near Silver Peak, Nevada.
“The lithium hydroxide samples produced by our team represent another important milestone for the Company,” said Bill Willoughby, President and CEO of Century Lithium. “Up until this point, Century’s efforts have focused on making lithium carbonate as the end product for Angel Island. By producing high-purity lithium hydroxide, we show that Angel Island can supply another major lithium product for the domestic market.”
The lithium hydroxide samples were produced from lithium carbonate derived from Angel Island’s lithium claystone deposit and treated at the Demonstration Plant using Century Lithium’s patent-pending alkaline leach and Direct Lithium Extraction (“DLE”) process. The lithium hydroxide samples were produced on-site in a batch process using conventional liming conversion with calcium hydroxide to make high-purity, +99.5% lithium hydroxide.
The Company is also pursuing a direct lithium conversion (“DLC”) process to produce lithium hydroxide directly from lithium chloride solution. Such a process would thereby bypass lithium carbonate as an intermediate stage, simplify operations, and reduce energy consumption and operating costs.
With the demand for mobile and stationary energy storage growing, Century Lithium’s project at Angel Island is strategically positioned as the United States seeks a reliable domestic source of critical materials. Lithium carbonate is an essential component for LFP batteries, while lithium hydroxide is needed for high-energy-density NMC/NCA batteries. By demonstrating the potential to produce both, Angel Island stands out as a potential key contributor to American energy independence and a resilient battery supply chain.
Qualified Person
Todd Fayram, MMSA-QP and Senior Vice President, Metallurgy of Century Lithium is the qualified person as defined by National Instrument 43-101 and has approved the technical information in this release.
ABOUT CENTURY LITHIUM CORP.
Century Lithium Corp. is an advanced-stage lithium company, focused on developing its 100%-owned lithium project Angel Island in Esmeralda County, Nevada, which hosts one of the largest sedimentary lithium deposits in the United States. The Company has utilized its patent-pending process for chloride leaching combined with direct lithium extraction to make battery-grade lithium carbonate product samples from Angel Island’s lithium-bearing claystone at its Demonstration Plant in Amargosa Valley, Nevada.
Angel Island is one of the few advanced lithium projects in development in the United States to provide an end-to-end process to produce battery-grade lithium carbonate for the growing electric vehicle and battery storage market. Angel Island is currently in the permitting stage for a three-phase feasibility-level production plan, expected to yield an estimated life-of-mine average of 34,000 tonnes per year of lithium carbonate over a 40-year mine-life.
Century Lithium trades on both the TSX Venture Exchange under the symbol “LCE” and the OTCQX under the symbol “CYDVF”, and on the Frankfurt Stock Exchange under the symbol “C1Z”.
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THE CONTENT OF THIS NEWS RELEASE.
This release contains certain forward-looking statements within the meaning of applicable Canadian securities legislation. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved” and similar expressions suggesting future outcomes or statements regarding an outlook.
Forward-looking statements relate to any matters that are not historical facts and statements of our beliefs, intentions and expectations about developments, results and events which will or may occur in the future, without limitation, statements with respect to the potential development and value of the Project and benefits associated therewith, statements with respect to the expected project economics for the Project, such as estimates of life of mine, lithium prices, production and recoveries, capital and operating costs, IRR, NPV and cash flows, any projections outlined in the Feasibility Study in respect of the Project, the permitting status of the Project and the Company’s future development plans.
These and other forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.These risks include those described under the heading “Risk Factors” in the Company’s most recent annual information form and its other public filings, copies of which can be under the Company’s profile at www.sedarplus.com. The Company expressly disclaims any obligation to update forward-looking information except as required by applicable law. No forward-looking statement can be guaranteed, and actual future results may vary materially. Accordingly, readers are advised not to place reliance on forward-looking statements or information. Furthermore, Mineral Resources that are not Mineral Reserves do not have demonstrated economic viability.
HBT Financial, Inc. (NASDAQ: HBT) announced a definitive agreement to acquire CNB Bank Shares, Inc. (OTC: CNBN) in a cash-and-stock deal valued at roughly $170.2 million, marking a significant strategic expansion in the community banking space. The transaction reflects HBT’s disciplined growth model and highlights continued consolidation among Midwest-based financial institutions.
The merger, expected to close in the first quarter of 2026, will create a combined company with about $6.9 billion in total assets, $4.7 billion in loans, and $5.9 billion in deposits. Post-closing, the new banking entity will operate 84 branches throughout Illinois, eastern Iowa, and Missouri—furthering HBT’s regional diversification across key metropolitan markets, including Chicago and St. Louis.
Transaction Structure and Valuation
Under the terms of the agreement, CNBN shareholders can elect to receive 1.0434 shares of HBT stock, $27.73 in cash per share, or a mix of both, subject to allocation limits. Based on HBT’s 15-day volume weighted average price of $24.44 as of October 17, 2025, the transaction equates to an implied purchase price of $25.92 per CNBN share. Upon completion, former CNBN shareholders will collectively own roughly 15% of HBT’s outstanding common stock.
The deal’s all-in valuation represents a prudent premium relative to CNBN’s recent trading levels while allowing HBT to fund the acquisition through a balanced consideration structure. The merger’s financial terms suggest a price-to-tangible book ratio in the 1.45x–1.55x range, consistent with recent peer transactions in the community banking sector.
Strategic Rationale and Market Outlook
For HBT, the acquisition deepens its deposit base in central Illinois and expands its reach into higher-growth urban corridors. It also enhances scale—both economically and operationally—adding efficiency to product distribution and technology deployment. CNB’s strong commercial loan portfolio and stable funding mix are expected to complement HBT’s disciplined credit culture, supporting accretive earnings growth post-integration.
Management expects the transaction to be additive to HBT’s earnings per share within the first full year after closing, with modest tangible book value dilution that can be earned back within a reasonable timeframe. The company’s strong capital position and consistent profitability metrics provide flexibility to absorb integration costs and offset potential short-term pressures.
On CNBN’s side, the merger offers shareholders liquidity through the NASDAQ-listed HBT stock and participation in a larger, more diversified Midwestern franchise. The combination should also benefit CNB’s customers through expanded product offerings and access to broader operational resources.
Leadership and Governance
To maintain local continuity, HBT has agreed to appoint CNBN directors James T. Ashworth and Nancy Ruyle to the boards of HBT Financial and Heartland Bank and Trust Company. The alignment of leadership under HBT’s community-first philosophy is expected to ease cultural integration—a critical factor in regional bank mergers.
Bottom Line
HBT’s acquisition of CNB Bank Shares continues its steady M&A track record, marking its eleventh transaction since 2007. By combining two relationship-focused institutions with complementary footprints, the deal strengthens HBT’s positioning in an increasingly competitive small and mid-cap financial landscape. For investors, it reinforces HBT’s strategy of measured expansion and capital discipline, positioning the company for sustainable earnings growth across Midwest markets.
Company’s Board Authorizes Strategic Purchases of up to $5 Million of Bitcoin and Trump Coin
BOCA RATON, FL / ACCESS Newswire / October 16, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced that the Company’s Board of Directors has authorized a strategic purchase plan of up to $5 million to purchase Bitcoin and Trump Coin over the next 12 months, subject to market conditions.
Newsmax expects to join more than 100 public companies that hold Bitcoin or other cryptocurrencies on their balance sheets. According to BitcoinTreasuries data, public company-held coin represents over 4.7% of total Bitcoin in circulation.
Newsmax also plans to add official Trump Coin to its strategic crypto reserve. The popular meme coin was launched earlier this year by President Trump and the circulating coin value exceeds $1.2 billion today with a total coin market value of around $6 billion, according to figures from Coinbase.
“Bitcoin is fast becoming the gold standard of cryptocurrency, and we believe it would be an important company marker to add this asset to our company reserves,” Newsmax CEO Christopher Ruddy said.
“We are also excited to add Trump Coin to our cryptocurrency plan, as we believe the coin’s value should track the success of the Trump presidency, which so far has been impressive,” Ruddy continued.
After making such a purchase, Newsmax expects to be the first NYSE company to purchase Trump Coin.
Newsmax anticipates making the first tranche of cryptocurrency purchases in the near future. Additional cryptocurrency acquisitions will be evaluated based on market conditions, operational requirements and strategic objectives. The Company maintains flexibility to adjust its digital asset strategy as market conditions evolve.
Newsmax has established comprehensive protocols for digital asset custody and management, partnering with leading institutional cryptocurrency services providers to ensure secure storage and handling of its cryptocurrency reserves.
This past March, President Trump announced the establishment of a Strategic Bitcoin Reserve for the United States. The fund is expected to begin with forfeited government Bitcoin and will grow with a Digital Asset Stockpile made up of other cryptocurrencies.
Newsmax listed on the NYSE in March 2025 after a historic Private Preferred raise and Regulation A+ IPO offering that successfully raised $300 million.
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 cable stations, as well as a major satellite system. Newsmax’s media properties reach more than 40 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 20 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”
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 our ability to change the direction of Newsmax, our ability to keep pace with new technology and changing market needs, the competitive environment of our business changes in domestic and global general economic and macro-economic conditions and/or uncertainties and 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.
CHARLOTTE, N.C., Oct. 16, 2025 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, announced today that it will release its third quarter 2025 financial results for the period ended September 30th, 2025, after the close of the market on Wednesday, October 29th, 2025. The Company will hold a related conference call on Thursday, October 30th, 2025, at 9:00 a.m. E.T. Participants on the call are asked to register five to ten minutes prior to the scheduled start time by dialing 1-877-255-4315 and from outside the U.S. at 1-412-317-6579.
The conference call will be webcast simultaneously and in its entirety through the NN, Inc. Investor Relations website. Shareholders, media representatives and others may participate in the webcast by registering through the Investor Relations section on the company’s website at https://investors.nninc.com/.
For those who are unavailable to listen to the live call, a replay will be available shortly after the call on NN’s website through October 31st, 2026.
About NN, Inc. NN, Inc., a global diversified industrial company, combines advanced engineering and production capabilities with in-depth materials science expertise to design and manufacture high-precision components and assemblies for a variety of markets on a global basis. Headquartered in Charlotte, North Carolina, NN has facilities in North America, Europe, South America, and Asia. For more information about the company and its products, please visit www.nninc.com.
Investor Relations: Joe Caminiti or Stephen Poe NNBR@alpha-ir.com 312-445-2870
LAKE ZURICH, Ill.–(BUSINESS WIRE)– ACCO Brands Corporation (NYSE: ACCO) today announced that it will release its third quarter 2025 earnings after the market close on October 30, 2025. The Company will host a conference call and webcast to discuss the results on October 31 at 8:30 a.m. EST. The webcast can be accessed through the Investor Relations section of www.accobrands.com and will be available for replay.
About ACCO Brands Corporation
ACCO Brands is the leader in branded consumer products that enable productivity, confidence and enjoyment while working, when learning and while playing. Our widely recognized brands include AT-A-GLANCE®, Five Star®, Kensington®, Leitz®, Mead®, PowerA®, Swingline®, Tilibra® and many others. More information about ACCO Brands Corporation (NYSE: ACCO) can be found atwww.accobrands.com.
NX-801 is a live virus vaccine investigational candidate, designed to provide durable protection against mpox and smallpox
TNX-801 demonstrated favorable safety, immunogenicity, and long-term protection in multiple preclinical models
Data support advancement of TNX-801 toward clinical development
CHATHAM, N.J., Oct. 17, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”) presented data in an oral presentation at the World Vaccine Congress–Europe 2025, held October 14–16, 2025, in Amsterdam, the Netherlands. A copy of the Company’s presentation, titled “Safety, Durability and Protection of a Single-Dose TNX-801 Mpox Vaccine,” is available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.
“Vaccines remain a cornerstone of pandemic preparedness and biodefense,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented in Amsterdam support the potential of TNX-801 as a next-generation orthopoxvirus vaccine candidate with the ability to confer durable protection. We believe TNX-801 has the potential to strengthen global readiness for emerging and re-emerging poxvirus threats.”
TNX-801 is a live, attenuated, minimally replicative investigational vaccine candidate based on horsepox virus and is being developed to protect against mpox (monkeypox) and smallpox. Preclinical data presented by Sina Bavari, Ph.D., Executive Vice President, Infectious Disease Research at Tonix Pharmaceuticals, demonstrated that TNX-801 produced durable immune protection following a single dose and was well tolerated across multiple routes of administration, including percutaneous, subcutaneous, and intramuscular delivery. TNX-801 elicited strong neutralizing antibody responses and protected animals from clinical disease and mortality following mpox challenge in non-human primate, rabbit, and murine models. Immunogenicity and durability were observed for at least 14 months post-vaccination.
“We are encouraged by the consistency and durability of the TNX-801 data across multiple preclinical models,” said Dr. Sina Bavari. “We are also excited by the opportunity to evaluate microneedle patch technology as a novel delivery platform to simplify administration and expand vaccine accessibility in future development stages.”
About TNX-801* TNX-801 (recombinant horsepox virus) is an, attenuated, minimally replicative, live virus vaccine based on horsepox in pre-clinical development to prevent mpox and smallpox. Tonix reported positive preclinical efficacy data, demonstrating that TNX-801 vaccination protected non-human primates against lethal challenge with monkeypox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and decreased shedding in the mouth and lungs of non-human primates. The findings are consistent with mucosal immunity and suggest the ability to block forward transmission, similar to Dr. Edward Jenner’s vaccine, which eradicated smallpox and kept mpox out of the human population. TNX-801 is based on synthesized horsepox which is believed to be more closely related to Dr. Jenner’s vaccine than 20th century vaccinia viruses. Smallpox vaccines descended from Jenner’s vaccine used prior to 1900 would be called horsepox by modern nomenclature.. Tonix has received official written response from a Type B pre-Investigational New Drug Application (IND) meeting with the U.S. Food and Drug Administration (FDA) to develop TNX-801 as a potential vaccine to protect against mpox disease and smallpox. Tonix has announced a collaboration with the Kenya Medical Research Institute (KEMRI) to design, plan and seek regulatory approval for a Phase I clinical study of TNX-801 in Kenya. The Company believes TNX-801 has the potential to make a global impact on mpox and the risk of smallpox because of its durable T-cell immune response, the potential to manufacture at scale, and the use of a lower dose than non-replicating vaccines. The FDA-approved non-replicating mpox vaccine Jynneos® requires two doses and provides a relatively short duration of protection. FDA also recently approved ACAM2000, a live, replicating vaccinia vaccine for prevention of mpox. ACAM200 is a clone from DryVax®, a 20th century vaccinia vaccine derived from the NYCBH strain. Pre-clinical results from an mRNA vaccine recently showed some protection from a Clade I monkeypox challenge, but with multiple break-through lesions in vaccinated animals.
Tonix Pharmaceuticals Holding Corp.* Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. 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 a Physician-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 an 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. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a 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 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.
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.
Conference call and webcast to discuss results to be held on November 7, 2025 at 8:00 a.m. ET
IRVINE, Calif., Oct. 17, 2025 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (Nasdaq: ELDN) today announced an oral presentation will be featured at the American Society of Nephrology’s upcoming Kidney Week 2025 Annual Meeting taking place in Houston, TX, from November 5-8, 2025. The oral presentation will highlight topline results from the Phase 2 BESTOW trial evaluating tegoprubart for the prevention of rejection in kidney transplantation.
Details of the oral presentation are below:
Title: Efficacy and Safety of Tegoprubart for the Prevention of Rejection in Kidney Transplantation: Results from the Phase 2 BESTOW Trial Presenter: Andrew Adams, M.D., Ph.D., Professor of Surgery and Chief Division of Transplantation, John S. Najarian Surgical Chair in Clinical Transplantation, Department of Surgery, University of Minnesota; Executive Medical Director, Solid Organ Transplant Service Line, M Health Fairview Abstract Publication Number: TH-OR089 Session Title: Late-Breaking Research Orals – 1 Session Date and Time: November 6, 2025, from 4:30 p.m. to 6:00 p.m. CT Session Room: Grand Ballroom C (Convention Center) Presentation Time: 5:30 p.m. to 5:42 p.m. CT
Conference Call
Eledon will hold a conference call on November 7, 2025 at 8:00 a.m. Eastern Time to discuss the Phase 2 BESTOW trial results presented at Kidney Week. The dial-in numbers are 1-800-717-1738 for domestic callers and 1-646-307-1865 for international callers. The conference ID is 92427. A live webcast of the conference call will be available on the Investor Relations section of the Company’s website at www.eledon.com. The webcast will be archived on the website following the completion of the call.
About Eledon Pharmaceuticals and tegoprubart
Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.
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Deal strengthens neuromodulation lineup with battery-free neurostimulation system
Boston Scientific Corporation (NYSE: BSX) announced Friday that it has entered into a definitive agreement to acquire Nalu Medical, Inc., a privately held medical technology company specializing in minimally invasive treatments for chronic pain.
Under the terms of the agreement, Boston Scientific will pay approximately $533 million in cash for the remaining equity of Nalu Medical that it does not already own. The company has been a strategic investor in Nalu since 2017. The transaction, expected to close in the first half of 2026, remains subject to customary closing conditions.
Nalu’s flagship product, the Nalu Neurostimulation System, is designed to deliver targeted relief for adults suffering from severe, intractable chronic pain of peripheral nerve origin — including pain in the shoulder, lower back, and knee. The system delivers mild electrical impulses to interrupt pain signals before they reach the brain and features a miniaturized, battery-free implantable pulse generator powered wirelessly by an external therapy disc and controlled via a smartphone app.
The U.S. Food and Drug Administration cleared the Nalu system in 2019. Results from the COMFORT and COMFORT 2 clinical trials demonstrated significant and sustained pain reduction, with 87% of participants in the first trial reporting more than 50% pain reduction at 12 months and 79% in the second trial achieving an average 64% reduction at six months. Real-world data from over 2,000 patients reinforced these outcomes, with 94% experiencing clinically meaningful improvement.
“Peripheral nerve stimulation is an exciting field with a significant unmet patient need,” said Jim Cassidy, president of Neuromodulation at Boston Scientific. “Adding Nalu Medical’s highly differentiated technology complements our existing therapies — including spinal cord stimulation, basivertebral nerve ablation, and radiofrequency ablation — and enables us to deliver advanced pain relief options to a wider variety of patient populations.”
Boston Scientific expects Nalu to generate over $60 million in sales in 2025 and to deliver growth exceeding 25% in 2026. The acquisition is projected to be immaterial to adjusted EPS in 2026, slightly accretive in 2027, and increasingly accretive thereafter. On a GAAP basis, the company expects the deal to be more dilutive due to amortization and acquisition-related expenses.
Nalu Medical, headquartered in Carlsbad, California, has been repeatedly recognized for innovation, including being named among the top 100 new products globally by R&D Magazine and winning multiple Medical Design Excellence Awards. Its compact, modular neurostimulation system represents a next-generation approach to chronic pain management by reducing the need for frequent interventions and improving patient comfort.
Boston Scientific, based in Marlborough, Massachusetts, is a global medical technology leader with a 45-year history of advancing science and developing solutions that improve patient outcomes across multiple therapeutic areas.
Massive trading volume follows dual announcements boosting balance sheet and strategic outlook
Rani Therapeutics Holdings (NASDAQ: RANI) surged more than 200% in early trading Friday, with over 240 million shares changing hands — a dramatic increase from its three-month average daily volume of just over 600,000. The spike follows back-to-back announcements of a major collaboration agreement with Chugai Pharmaceutical Co. worth up to $1.085 billion and an oversubscribed $60.3 million private placement.
The collaboration with Japan-based Chugai — a member of the Roche Group — covers multiple high-value therapeutic programs, including those in rare diseases and immunology. Under the deal, Rani will receive a $10 million upfront payment and is eligible for up to $75 million in technology transfer and development milestones, $100 million in sales milestones, and single-digit royalties on future product sales. Chugai also has the option to partner on up to five additional drug targets under similar terms, which could bring the total potential deal value to more than $1 billion.
“This partnership represents a convergence of Rani’s cutting-edge oral delivery platform and Chugai’s expertise in antibody development,” said Rani Therapeutics CEO Talat Imran. “We’re uniting two powerful scientific teams to develop oral therapies that could redefine treatment for rare and immunologic diseases globally.”
Alongside the collaboration, Rani announced a $60.3 million private placement priced at-the-market under Nasdaq rules, led by new investor Samsara and joined by RA Capital Management, Anomaly, Special Situations Funds, Invus, and Rani’s Executive Chairman Mir Imran. The oversubscribed financing includes 42.6 million shares of Class A common stock and 82.4 million pre-funded warrants, each accompanied by warrants to purchase additional shares.
Rani said the net proceeds from the offering, combined with the upfront and milestone payments from Chugai, will extend its operating runway into 2028 and fund advancement of its RaniPill® platform — a proprietary oral delivery system designed to replace subcutaneous or intravenous biologic injections with oral capsules.
“We believe this additional financing from leading biotech investors reflects growing confidence in our strategy,” said Imran. “Together, this financing and our strategic partnership with Chugai mark a pivotal moment for Rani.”
At the closing of the financing, Samsara and Anomaly will each have the right to appoint a member to Rani’s board of directors.
Rani Therapeutics, based in San Jose, California, is a clinical-stage biotherapeutics company focused on developing orally administered biologics and drugs using its RaniPill® platform technology.
