ISG (Information Services Group) (Nasdaq: III) is a leading global technology research and advisory firm. A trusted business partner to more than 700 clients, including more than 75 of the world’s top 100 enterprises, ISG is committed to helping corporations, public sector organizations, and service and technology providers achieve operational excellence and faster growth. The firm specializes in digital transformation services, including automation, cloud and data analytics; sourcing advisory; managed governance and risk services; network carrier services; strategy and operations design; change management; market intelligence and technology research and analysis. Founded in 2006, and based in Stamford, Conn., ISG employs more than 1,300 digital-ready professionals operating in more than 20 countries—a global team known for its innovative thinking, market influence, deep industry and technology expertise, and world-class research and analytical capabilities based on the industry’s most comprehensive marketplace data. For additional information, visit www.ISG-One.com
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Raising Price Target. We are raising our price target on III shares to $6.50 from a prior $5, as III shares have exceeded our price target. The recent and expected future interest rate cuts, ongoing cost optimization efforts from clients, and the increasing pace of AI adoption will continue to drive ISG’s operating performance, in our view.
Valuation. At our $6.50 price target, III shares would trade at 1.4x our 2026 revenue estimate on an EV/sales basis, 10.7x on an EV/projected 2026 adjusted EBITDA basis, and 19.1x adjusted 2026 earnings. This compares to a peer group that trades at 1.3x, 10x, and 15.8x, respectively, consensus 2026 estimates.
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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.
NEW YORK, Sept. 19, 2025 (GLOBE NEWSWIRE) — Xcel Brands, Inc. (NASDAQ: XELB), a media and consumer products company known for building influential, creator-led brands, today announced the appointment of Olin C. Lancaster as Chief Revenue Officer. With more than three decades of leadership in global consumer brands, Lancaster brings a proven track record of driving revenue growth, brand building, and operational excellence.
Lancaster’s career spans senior leadership roles at Kenneth Cole, DKNY, Global Brands Group, Ralph Lauren, and most recently Meridian Brands, where he served as CEO. At Ralph Lauren, he oversaw the North American wholesale business which experienced significant growth and profit expansion during his tenure. At Meridian, he guided the company through a successful rebrand and restructuring, significantly strengthening profitability and operational performance.
“Olin is one of the most respected leaders in our industry with an unmatched ability to scale brands and drive profitability,” said Robert W. D’Loren, Chairman and CEO of Xcel Brands. “His extensive experience across wholesale, retail, and brand operations makes him a powerful addition to our leadership team as we continue to expand our portfolio of creator-led and digitally driven businesses.”
“I am truly excited to join XCEL and work closely with Bob D’Loren and the team. Activating and monetizing brands today is difficult and expensive. XCEL is as much a media company as it is a brand management and licensing company, and I believe that is the real unlock in our ability to attract and create value with our partners, both on the founder/creative side and with our operators,” said Olin Lancaster.
Originally from Dallas, Texas, Lancaster is a graduate of Southern Methodist University, where he earned a BA in History with minors in Business and Economics. Lancaster also serves on the board of Mizzen + Main and is an active supporter of The Meadows Foundation in Dallas.
About Xcel Brands Xcel Brands, Inc. (NASDAQ: XELB) is a media and consumer products company engaged in the design, licensing, marketing, live streaming, and social commerce sales of branded apparel, footwear, accessories, fine jewelry, home goods and other consumer products, and the acquisition of dynamic consumer lifestyle brands. Xcel was founded in 2011 with a vision to reimagine shopping, entertainment, and social media as social commerce. Xcel owns the Halston, Judith Ripka, and C. Wonder brands, as well as the co-branded collaboration brands Towerhill by Christie Brinkley, Trust. Respect. Love by Cesar Millan, GemmaMade by Gemma Stafford, and a brand in development with Coco Rocha and also holds noncontrolling interests or long-term license agreements in the Isaac Mizrahi brand, Orme Live, and Mesa Mia by Jenny Martinez. Xcel also owns and manages the Longaberger brand through its controlling interest in Longaberger Licensing, LLC. Xcel is pioneering a true modern consumer products sales strategy which includes the promotion and sale of products under its brands through interactive television, digital live-stream shopping, social commerce, brick-and-mortar retailers, and e-commerce channels to be everywhere its customers shop. The company’s brands have generated in excess of $5 billion in retail sales via livestreaming in interactive television and digital channels alone, and over 20,000 hours of content production time in live-stream and social commerce. The brand portfolio reaches in excess of 43 million social media followers with broadcast reach into 200 million households. Headquartered in New York City, Xcel Brands is led by an executive team with significant live streaming, production, merchandising, design, marketing, retailing, and licensing experience, and a proven track record of success in elevating branded consumer products companies. For more information, visit www.xcelbrands.com.
NN Proudly Extends its Successful China Joint Venture
Wuxi Weifu Autocam team celebrates 20 year anniversary of the JV partnership
CHARLOTTE, N.C., Sept. 18, 2025 (GLOBE NEWSWIRE) — NN, Inc. (NASDAQ: NNBR), a global diversified industrial company that engineers and manufactures high-precision components and assemblies, has announced that the Chinese government has approved the application for the continuation of its Joint Venture (“JV”) in Wuxi, China. This formal approval now extends the successful 20-year partnership between NN, Inc. and Weifu, a Chinese publicly traded company, on an ongoing basis.
Harold Bevis, Chief Executive Officer of NN, Inc. stated, “We are very proud of the JV, and together with our partner Weifu we have been able to strategically grow this business consistently over the 20-year partnership. The team is strong, growing and delivers high-level performance. The products of the JV are critical to vehicle performance and highly valued by our customers and local automotive OEMs. The China auto industry is a standout on the global stage and we are happy to play a key role in this attractive growth market through both our JV and our wholly-owned businesses. NN has more than $200 million of profitable sales across its three China businesses, which is our largest global automotive market. We look forward to many years of continued success and value creation in our China operations.”
Known in the China automotive market as Wuxi Weifu Autocam, the JV business has demonstrated consistent growth, now delivering sales of approximately $130 million USD per year. The business supplies high-end parts to the China automotive market for both indigenous consumption and for key export markets. China is the largest auto market in the world at about 29 million passenger vehicles per year, compared to the US auto market of about 16 million cars per year. The Joint Venture Is a key supplier to all major OEMs in China, including BYD.
The business is currently going through an expansion, having won additional business and has recently outgrown its current building footprint, which employs over 550 people across 3 shifts.
Paul Wang, NN’s President of APAC operations serves as the General Manager of the Joint Venture, reporting to Harold Bevis, CEO of NN. Harold Bevis and NN’s Chief Operating Officer, Tim French, both serve on the Board of Directors of the Joint Venture company. The business is 51% owned by Weifu, and 49% owned by NN, Inc. NN also has a wholly-owned machined parts business in Wuxi, China and a wholly-owned stamped parts business in Foshan, China. Together, these three businesses serve the automotive, industrial and medical markets, deliver $200+ million in profitable sales, and employ over 1,200 employees.
Wuxi Weifu Autocam facility
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, Investors NNBR@alpha-ir.com 312-445-2870
Photos accompanying this announcement are available at
Ocugen, Inc. is a biotechnology company focused on developing and commercializing novel gene therapies, biologicals, and vaccines. The lead product in its gene therapy program, OCU400, is in Phase 1/2 clinical trials for retinitis pigmentosa.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
OCU400 Licensing Completed. Ocugen has announced the completion of a licensing agreement for Korea with Kwangdong Pharmaceutical, Co., Ltd., a diversified pharmaceutical company in the Republic of South Korea. This finalizes the term sheet announced in August with the 2Q25 business update. We have based our revenue expectations on US and Europe, with the Korea agreement adding additional cash upon the signing and downstream royalties.
Agreement Provides Cash, Milestones, and Royalties. The terms provide Ocugen with signing and near-term milestones of $7.5 million. Under the agreement, Ocugen will manufacture and supply OCU400 in exchange for a royalty of 25% of Net Sales plus sales milestones of $1 million for every $15 million in Net Sales, or roughly 32% per $15 million in sales. There are an estimated 7,000 retinitis pigmentosa (RP) patients in Korea, with an estimated market of about $180 million over the first 10 years of sales. We estimate these potential payments at about $65 million to Ocugen.
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.
U.S. equities extended their gains on Thursday, with the Russell 2000 index of small-cap stocks taking center stage as investors embraced the Federal Reserve’s latest policy shift. The move comes just a day after the central bank announced its first interest-rate cut of 2025, a decision that has sparked optimism about economic growth and reignited appetite for smaller, more domestically focused companies.
The Russell 2000 soared more than 2% to an intraday record, positioning itself for its first all-time closing high since November 2021. This surge has placed the index firmly ahead of its large-cap peers, with the S&P 500 climbing 0.5% and the Nasdaq Composite adding 1.1%. The Dow Jones Industrial Average rose 120 points, or 0.3%.
For small-cap investors, the Fed’s move signals a potential turning point. Unlike cash-rich technology giants that can weather higher borrowing costs, small- and mid-cap companies often rely heavily on external financing to support operations and growth. Lower interest rates reduce that burden, freeing up capital for expansion and making smaller firms more attractive to investors.
Beyond the macroeconomic boost, market sentiment has improved notably since the Fed’s policy shift. The American Association of Individual Investors (AAII) reported a surge in bullish sentiment this week, with 41.7% of respondents now optimistic on the short-term outlook for stocks, up sharply from 28% the previous week. While bearish views remain elevated, the optimism highlights growing confidence that the Fed’s pivot will continue to lift equities.
The Russell’s outperformance is also being fueled by a broadening of market participation. For much of the past year, the rally in U.S. equities has been concentrated in mega-cap technology names driven by artificial intelligence enthusiasm. The rate cut has shifted attention to smaller companies that had largely lagged during the high-rate environment. With valuations still relatively attractive compared to large-cap counterparts, the Russell’s resurgence is attracting both institutional and retail inflows.
Meanwhile, the broader market rally was supported by strength in both traditional and technology sectors. Notably, Intel surged more than 25% after Nvidia announced a $5 billion investment to co-develop chips for data centers and PCs, sending Nvidia shares up more than 3%. While big tech continues to contribute, the spotlight remains firmly on the Russell’s record-setting move.
Looking ahead, investors will closely watch whether the Fed follows through with its projection of two additional rate cuts before year-end. Continued monetary easing could further unlock momentum for small-cap stocks, though analysts caution that too much stimulus could risk overheating both markets and the broader economy.
For now, however, the Russell 2000 has emerged as the clear winner of the Fed’s rate shift—marking a powerful comeback for small-cap investors after nearly four years without a record high.
U.S. equity funds faced significant withdrawals last week as investors rushed to lock in profits following a powerful rally fueled by the Federal Reserve’s policy shift. According to LSEG Lipper data, equity funds saw $43.19 billion in outflows in the week ending September 17, marking the largest withdrawal since December 2024.
The selloff came just as the S&P 500 surged to a record 6,656.8, representing a nearly 38% climb from its April 2024 low of 4,835. The sharp rally, combined with stretched valuations, prompted investors to reallocate capital to safer assets. Market watchers noted that forward price-to-earnings ratios for the index are now sitting at levels rarely seen over the past two decades, making equities vulnerable to profit-taking and potential volatility.
Large-cap funds bore the brunt of the outflows, shedding $34.19 billion in the week — the biggest drawdown since at least 2020. Mid-cap funds also recorded $1.58 billion in redemptions, while small-cap funds bucked the trend with a modest $50 million in inflows. Sector funds were not spared either, with technology-focused vehicles suffering $2.84 billion in withdrawals, contributing to a net $1.24 billion outflow across all sectors.
While equities stumbled, fixed income funds continued to attract investor attention. U.S. bond funds saw $7.33 billion in fresh inflows, extending their streak to 22 consecutive weeks. Short-to-intermediate investment-grade funds led the way, alongside general domestic taxable fixed income products and municipal debt funds, which all posted over $1 billion in gains.
Meanwhile, money market funds experienced a sharp reversal. After three straight weeks of net inflows, investors pulled $23.65 billion, suggesting a shift away from cash holdings as capital moved into bonds and other yield-generating instruments.
The rotation underscores two structural themes shaping markets this fall: heightened caution on overextended equity valuations and a renewed appetite for fixed income as investors prepare for a more dovish Federal Reserve in the months ahead. With rate cuts expected to continue, bond yields remain attractive compared to the perceived risks of chasing equities at record highs.
This move comes just days after the Russell 2000 hit a record high, signaling shifting dynamics between large- and small-cap stocks. However, the latest flow data suggests that, despite optimism about monetary policy, many investors prefer to secure recent gains rather than risk a pullback.
The coming weeks will be pivotal as markets digest the Fed’s updated economic projections and policy guidance. Whether the current profit-taking proves temporary or marks the beginning of a broader correction may depend on how quickly earnings growth can catch up with elevated valuations.
Elon Musk’s artificial intelligence venture, xAI, has secured a massive $10 billion funding round that values the startup at $200 billion, according to reports from CNBC. The raise highlights the continued investor enthusiasm in the artificial intelligence sector, even as questions swirl about tech spending and long-term sustainability.
The new valuation more than doubles the company’s $75 billion mark from just two months earlier, underscoring the accelerating pace of capital flowing into AI. With this milestone, xAI now ranks among the world’s most valuable private technology companies, sitting alongside global heavyweights such as OpenAI, ByteDance, and Musk’s own SpaceX.
Expanding AI Infrastructure
Much of the funding is expected to be deployed toward data centers powered by advanced Nvidia and AMD graphics processors, a crucial component in developing and training next-generation AI systems. Analysts note that GPU-driven clusters are the backbone of today’s AI race, as firms compete to push the boundaries of model performance, scalability, and reliability.
xAI has already made headlines for Colossus, its supercomputer cluster in Memphis, Tennessee, which the company claims is the largest of its kind worldwide. The expansion of this infrastructure signals Musk’s intent to ensure that xAI can rival established leaders like OpenAI and Anthropic in the high-stakes competition to dominate the AI landscape.
The funding round arrives at a time when competitors are also securing significant backing. Earlier this month, Anthropic raised $13 billion at a valuation of $183 billion, while OpenAI is reportedly in talks for a stock sale that could value the company at around $500 billion. ByteDance, meanwhile, is preparing a new employee share buyback program at a valuation of more than $330 billion.
By entering the $200 billion valuation club, xAI not only signals its arrival among elite AI firms but also highlights the fierce battle for both talent and infrastructure. Much of the new capital is expected to go toward recruiting top AI researchers and engineers—an area where costs continue to rise as demand far exceeds supply.
Building Toward the Future
Musk’s AI ambitions go beyond technology alone. xAI acquired the social media platform X (formerly Twitter) earlier this year, giving it a unique advantage in terms of training data and user integration. By combining large-scale data resources with cutting-edge compute infrastructure, xAI is positioning itself as a long-term challenger to the sector’s biggest players.
The latest valuation leap reflects not just investor confidence in xAI, but also broader optimism that AI technologies will remain central to economic and business growth for years to come. With infrastructure rapidly scaling and capital continuing to pour in, xAI’s next steps will be closely watched as it attempts to shape the future of artificial intelligence.
FORT WORTH, Texas, Sept. 18, 2025 (GLOBE NEWSWIRE) — SEGG Media Corporation (NASDAQ: SEGG, LTRYW), (the “Company” or “SEGG Media”) the global sports, entertainment, and gaming conglomerate, today announced it has secured premium full-page advertisements in NFL Team Yearbooks for the 2025/26 season, which ensures SEGG Media’s presence across 25 of the NFL’s 30 stadiums.
The placements feature QR code integration, driving fans directly to Lottery.com and Sports.com, delivering seamless digital engagement from in-stadium experiences to SEGG Media’s online platforms.
The Company secured advertisements in NFL Team Yearbooks that include both Super Bowl LIX winner Philadelphia Eagles and runner-up Kansas City Chiefs. The SEGG Media advertisement also appears in both NFL Team Yearbooks featured in tonight’s Thursday Night Football match-up, Buffalo Bills vs Miami Dolphins at Hard Rock Stadium. A complete list of NFL Team Yearbooks containing SEGG Media’s advertisements are as follows:
Arizona Cardinals
Atlanta Falcons
Baltimore Ravens
Buffalo Bills
Carolina Panthers
Chicago Bears
Cincinnati Bengals
Cleveland Browns
Detroit Lions
Houston Texans
Indianapolis Colts
Jacksonville Jaguars
Kansas City Chiefs
Los Angeles Chargers
Los Angeles Rams
Miami Dolphins
New England Patriots
New Orleans Saints
New York Giants
New York Jets
Philadelphia Eagles
Pittsburgh Steelers
San Francisco 49ers
Tampa Bay Buccaneers
Washington Commanders
“This places SEGG Media at the heart of America’s biggest sport, delivering massive exposure for the Company and the Sports.com brand in front of one of the most passionate fan bases in the world,” said Matthew McGahan, Chairman, President & CEO of SEGG Media. “It’s another step in positioning SEGG Media as a leading global sports, entertainment, and gaming brand into the future.”
Marc Bircham, SEGG Media Board Director and Director of Sports.com, added: “SEGG Media has always recognized that to build a true sports media conglomerate we must capitalize on iconic American sports like the NFL, NBA, MLB, IndyCar, and NASCAR. This initiative demonstrates that we are delivering on our promises to shareholders by embedding ourselves in the heartbeat of U.S. sports and entertainment culture. Engaging directly with NFL fans is a vital steppingstone, and we are actively exploring additional opportunities for the 2025/26 season, from behind-the-scenes content to interactive fan experiences. By delivering engaging content, attracting new users and investors, and expanding not just here at home, but globally, the Company is positioning itself to stand front and center as one of the most dynamic media companies listed on major exchanges today.”
The NFL Team Yearbook initiative forms part of the Company’s wider U.S. expansion strategy, which includes sponsorships in IndyCar, partnerships in esports through Veloce and Quadrant, and the upcoming launch of Concerts.com.
About SEGG Media Corporation SEGG Media (Nasdaq: SEGG, LTRYW) is a global sports, entertainment and gaming group operating a portfolio of digital assets including Sports.com, Concerts.com and Lottery.com. Focused on immersive fan engagement, ethical gaming and AI-driven live experiences, SEGG Media is redefining how global audiences interact with the content they love.
Forward-Looking Statements
This press release contains statements that constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included in this press release, regarding the Company’s strategy, future operations, prospects, plans and objectives of management, are forward-looking statements. When used in this Form 8-K, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” “initiatives,” “continue,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. The forward-looking statements speak only as of the date of this press release or as of the date they are made. The Company cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of the Company. In addition, the Company cautions you that the forward-looking statements contained in this press release are subject to risks and uncertainties, including but not limited to: the Company’s ability to secure additional capital resources; the Company’s ability to continue as a going concern; the Company’s ability to complete acquisitions; the Company’s ability to remain in compliance with Nasdaq Listing Rules; and those additional risks and uncertainties discussed under the heading “Risk Factors” in the Form 10-K/A filed by the Company with the SEC on April 22, 2025, and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that the Company has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Should one or more of the risks or uncertainties described in this press release materialize or should underlying assumptions prove incorrect, actual results and plans could differ materially from those expressed in any forward-looking statements. Except as otherwise required by applicable law, the Company disclaims any duty to update any forward-looking statements, all of which are expressly qualified by the statements in this section, to reflect events or circumstances after the date of this press release.
For additional information, visit www.seggmediacorp.com or contact media relations at media@seggmediacorp.com
CHATHAM, N.J., Sept. 18, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced the successful completion of a Type B Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of TNX-102 SL (sublingual cyclobenzaprine HCl) for the treatment of major depressive disorder (MDD). The Company received positive feedback from the FDA and plans to pursue a supplemental new drug application (sNDA) to expand the therapeutic indication of TNX-102 SL to include MDD, based on exploratory findings suggesting that improving sleep quality may positively impact depressive symptoms.
“We are pleased with the outcome of our Pre-IND meeting with the FDA and appreciate their thoughtful guidance,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “This marks a significant step forward in our efforts to develop TNX-102 SL as a novel treatment for MDD, a condition that affects millions and remains underserved by current therapies that are often difficult to tolerate.”
“We believe bedtime TNX-102 SL has the potential to be a first-in-class treatment that is designed to target the reduced quality and quantity of slow wave sleep associated with depression,” said Dr. Gregory Sullivan, M.D., Chief Medical Officer of Tonix Pharmaceuticals. “TNX-102 SL is a tertiary amine tricyclic that is designed for transmucosal absorption to bypass first pass hepatic metabolism. In contrast, FDA-approved tertiary amine tricyclic antidepressants are swallowed pill formulations, that are largely metabolized by first-pass to longer-lived secondary amine tricyclics. Also, the FDA-approved tertiary amine tricyclic antidepressants are only active in treating MDD at more than ten times the dose employed with TNX-102 SL and can adversely impact weight, blood pressure, cognition, and sexual function.”
The FDA provided constructive feedback during the Pre-IND meeting for TNX-102 SL in MDD and found the proposed long-term safety data collection plan generally reasonable, potentially streamlining the development path.
An IND filing is planned for Q4 2025, positioning the program to enter Phase 2 clinical trials shortly thereafter. TNX-102 SL is FDA approved for the treatment of fibromyalgia, under the brand name Tonmya™. In the Phase 3 RESILIENT study of fibromyalgia patients, the TNX-102 SL – treated group had activity on improving depression over placebo by the Beck Depression Inventory (BDI), with an uncorrected p-value < 0.05. The biological relationship between depressed symptoms in fibromyalgia and those in MDD is not understood.
About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride that enables rapid transmucosal absorption and reduces production of the long half-life active metabolite, norcyclobenzaprine, by bypassing first-pass hepatic metabolism. As a tertiary amine tricyclic (TAT) and multifunctional agent with potent binding and antagonist activities at the 5-HT2A serotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors. It is currently approved in the U.S. as a once-daily bedtime treatment for fibromyalgia in adults. TNX-102 SL is also in development as a daily bedtime treatment for acute stress reaction/acute stress disorder. Tonix also holds active IND’s for the following indications for TNX-102 SL: Long COVID (post-acute sequelae of COVID-19), PTSD, alcohol use disorder, and agitation in Alzheimer’s disease. The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10357465 in July 2019, and Patent No. 10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary composition. These patents are expected to provide Tonmya with U.S. market exclusivity until 2034. Pending patent applications related to method of use could extend exclusivity until 2044.
Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix recently received FDA approval for Tonmya™, 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 and infectious diseases. 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). 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 infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as 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. TNX-4200 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 failure to successfully launch and commercialize Tonmya and any of our approved products; 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.
RESTON, Va., Sept. 18, 2025 /PRNewswire/ — V2X Inc., (NYSE: VVX), has been awarded a position on the Defense Threat Reduction Agency’s (DTRA) Cooperative Threat Reduction Integrating Contract IV (CTRIC IV). V2X is one of six recipients selected for this indefinite-deliver, indefinite-quantity contract, which carries a ceiling value of $3.5 billion over a five-year base period with five additional option years.
CTRIC IV supports the Department of Defense’s global Cooperative Threat Reduction program, which aims to reduce threats posed by weapons of mass destruction and related materials. Under this contract, V2X will execute current and future work to provide comprehensive support to counter and eliminate chemical, biological, radiological, and nuclear threats worldwide.
“This award underscores our proven ability to support high-consequence missions on a global scale,” said Jeremy C. Wensinger, President and Chief Executive Officer of V2X. “With our global footprint and strong operational capabilities, we are well-equipped to deliver innovative solutions in support of DTRA’s mission, wherever they are needed. We’re honored to be selected for the CTRIC follow-on contract, which reflects our track record of success. We look forward to building on this momentum and expanding our impact through this opportunity.”
The CTRIC IV contract expands V2X’s presence in critical global threat reduction efforts and reinforces its role as a trusted partner in domestic and international defense initiatives.
About V2X V2X builds innovative solutions that integrate physical and digital environments by aligning people, actions, and technology. V2X is embedded in all elements of a critical mission’s lifecycle to enhance readiness, optimize resource management, and boost security. The company provides innovation spanning national security, defense, civilian, and international markets. With a global team of approximately 16,000 professionals, V2X enables mission success by injecting AI and machine learning capabilities to meet today’s toughest challenges across all operational domains.
Investor Contact Mike Smith, CFA Vice President, Treasury, Corporate Development and Investor Relations IR@goV2X.com 719-637-5773
Media Contact Angelica Spanos Deoudes Director, Corporate Communications Angelica.Deoudes@goV2X.com 571-338-5195
(GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced the expansion of FLAMINGO-01 clinical trial to Ireland.
The Company’s application to European regulators has been formally approved, adding Ireland as an approved country in FLAMINGO-01 in addition to Spain, France, Germany, Italy, Poland, Romania, and the US.
According to the latest data collected by the European Cancer Information System (click here), a total of 3,723 new cases of breast cancer were diagnosed in Ireland in 2022, which is the most common cancer diagnosed in women, representing approximately 30% of all cancers in women. Breast cancer is the 2nd leading cause of death from cancer in women in Ireland with 883 deaths in 2022.
The Company is collaborating with Dr. Janice Walshe, who will be serving as the national principal investigator in Ireland for FLAMINGO-01. She is a key member of Cancer Trials Ireland research group ensuring access to novel agents and research opportunities for Irish women affected by breast cancer. Through the clinical research clinic in St Vincent’s University Hospital in Dublin, Ireland, she has served as national principal investigator for many important international trials in breast cancer. She served as a three-year member of ASCO Scientific Program Committee in triple negative breast cancer from 2013-2015. Her research has been presented at numerous international meetings and published in prestigious peer reviewed journals.
CEO Snehal Patel commented, “We have visited St. Vincent’s multiple times over the past few years, once to present GP2 and FLAMINGO-01 at their conference and most recently to train the study team. We have also been approached by Irish breast cancer patients who wish to participate in FLAMINGO -01 and who can now be considered for enrollment through the Dublin site.”
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
Investor & Public Relations Contact for Greenwich LifeSciences Dave Gentry RedChip Companies Inc. Office: 1-800-RED CHIP (733 2447) Email: dave@redchip.com
Swiss pharmaceutical leader Roche has announced an agreement to acquire clinical-stage biopharmaceutical company 89bio, Inc. in a deal valued at up to $3.5 billion. The acquisition is set to strengthen Roche’s cardiovascular, renal, and metabolism portfolio, particularly its capabilities in treating metabolic dysfunction-associated steatohepatitis (MASH).
Under the terms of the agreement, 89bio shareholders will receive $14.50 per share in cash at closing, along with a non-tradeable contingent value right (CVR) providing up to an additional $6.00 per share contingent on specific milestones. The CVR payments are linked to the commercial success and sales performance of 89bio’s lead candidate, pegozafermin, a novel fibroblast growth factor 21 (FGF21) analog designed for patients with moderate to severe MASH and severe hypertriglyceridemia.
Pegozafermin is currently in Phase 3 clinical trials and is engineered to provide extended biological activity through a proprietary glycoPEGylated technology. The therapy aims to address critical unmet medical needs in liver and cardiometabolic diseases, including patients with advanced fibrosis and compensated cirrhosis. Its potential best-in-disease profile makes it a significant addition to Roche’s portfolio, enhancing the company’s efforts to provide innovative treatment options to patients worldwide.
The contingent payments under the CVR are structured to reward milestone achievements, including the first commercial sale of pegozafermin in F4 MASH cirrhotic patients, and annual global sales thresholds of $3 billion and $4 billion in subsequent years. This structure aligns shareholder incentives with the commercial success of the therapy while reflecting the high growth potential of 89bio’s pipeline.
The acquisition is subject to customary closing conditions, including the tender of a majority of 89bio’s outstanding shares and regulatory approvals. Roche plans to complete the transaction in the fourth quarter of 2025, after which 89bio will become part of Roche’s Pharmaceuticals Division. Until the closing, 89bio will continue to operate independently, maintaining its focus on the development of innovative therapies for liver and cardiometabolic diseases.
Financial advisors for 89bio include Moelis & Company LLC and Centerview Partners LLC, with Gibson, Dunn & Crutcher LLP serving as legal counsel. Citi and Sidley Austin LLP act as Roche’s financial and legal advisors.
The acquisition positions Roche to potentially transform the standard of care for patients with metabolic liver diseases while leveraging 89bio’s advanced clinical pipeline. Analysts view the deal as a strategic move to capture emerging opportunities in high-growth therapeutics, combining 89bio’s innovative platform with Roche’s global development, manufacturing, and commercialization capabilities.
Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
New Craigmont mining lease extensions. Nicola Mining Inc. (OTCQB: HUSIF, TSX.V: NIM) secured a five-year extension for six mining leases at its New Craigmont Property from the Ministry of Mining and Critical Minerals. The New Craigmont property encompasses over 10,800 hectares and is adjacent to Teck Resources Limited’s (NYSE: TECK, TSX: TECK.A and TECK.B) Highland Valley Copper Mine, the largest copper mine in Canada. On June 1, Nicola commenced a 4,000-to-5,000-meter diamond drill program at the New Craigmont project. The mining lease extension ensures continuity through the project’s lifecycle.
Shipments of gold concentrate. Earlier this month, Nicola announced that it had commenced shipping gold concentrate via a partnership with Talisker Resources Ltd. (TSX: TSK, OTCQX: TSKFF). Under a Mining, Milling, and Smelting Agreement, the parties sold 707 ounces of gold in August, generating gross proceeds of approximately US$2.3 million. Production benefited from upgrades to the Merritt Mill, including the installation of a large concentrator that optimized free gold recovery.
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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.
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