Eli Lilly (NYSE: LLY) announced plans to invest $6.5 billion in a new manufacturing facility in Houston, Texas, designed to expand production of its pipeline of small molecule medicines, including the company’s highly anticipated oral obesity pill, orforglipron.
The facility will be the second of four new U.S.-based plants Lilly intends to open over the next five years, following a February pledge of at least $27 billion in domestic manufacturing investments. This adds to more than $23 billion the company has already spent since 2020 to scale operations in response to soaring demand for obesity and diabetes therapies.
The Houston site will play a critical role in Eli Lilly’s efforts to maintain its competitive lead in the rapidly expanding market for GLP-1 drugs. Unlike existing weekly injectable treatments, orforglipron is designed as an oral pill, offering patients a simpler alternative without food or water restrictions. Analysts believe the convenience factor could make orforglipron a blockbuster treatment if approved by regulators.
The race to scale production has become increasingly urgent. Both Eli Lilly and rival Novo Nordisk have faced supply challenges as demand for weight-loss medications surged across the United States. By boosting capacity, Lilly aims to ensure orforglipron can be manufactured at scale and delivered to tens of millions of patients worldwide.
The Houston facility will also support manufacturing of other small molecule medicines across a range of therapeutic areas, including cardiometabolic disease, oncology, immunology, and neuroscience. Small molecule drugs, which are typically produced in pill form, are generally easier and cheaper to manufacture than injectables, making them more accessible for patients and more efficient to scale globally.
In addition to strengthening its supply chain, Eli Lilly highlighted the economic impact of the new site. The project is expected to create 615 permanent jobs in the Houston area, spanning roles such as engineers, scientists, operations staff, and lab technicians. During construction, the facility will generate more than 4,000 temporary jobs, further supporting the region’s economy.
The company also emphasized that the move supports broader U.S. efforts to re-shore pharmaceutical manufacturing. In recent years, political pressure has mounted to reduce reliance on overseas drug production. By expanding its domestic footprint, Lilly positions itself as a leader in bringing pharmaceutical manufacturing back to the U.S. while meeting escalating global demand for obesity treatments.
With four new U.S. plants scheduled to be operational within five years, Eli Lilly is positioning itself at the forefront of the next generation of obesity and metabolic care. The Houston facility is expected to serve as a cornerstone of that strategy, ensuring supply can keep pace with demand in one of the fastest-growing markets in modern medicine.
Office Depot, Inc., together with its subsidiaries, supplies a range of office products and services. It offers merchandise, such as general office supplies, computer supplies, business machines and related supplies, and office furniture through its chain of office supply stores under the Office Depot, Foray, Ativa, Break Escapes, Worklife, and Christopher Lowell brand names. The company also provides graphic design, printing, reproduction, mailing, shipping, and other services through design, print, and ship centers. It has operations throughout North America, Europe, Asia, and Central America. The company also sells its products and services through direct mail catalogs, contract sales force, Internet sites, and retail stores, through a mix of company-owned operations, joint ventures, licensing and franchise agreements, alliances, and other arrangements. As of December 31, 2008, Office Depot operated 1,267 North American retail division office supply stores and 162 international division retail stores, as well as participated under licensing and merchandise arrangements in 98 stores. The company was founded in 1986 and is based in Boca Raton, Florida.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
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An Acquisition. Yesterday morning, The ODP Corporation announced it entered into a definitive agreement to be acquired by an affiliate of Atlas Holdings for $28/sh. The purchase price represents a premium of 34% to Friday’s closing price. ODP’s Board is supporting the transaction, which is expected to close by the end of 2025.
Who Is Atlas Holdings? Founded in 2002 by Andrew Bursky and Tim Fazio, Greenwich, CT-based Atlas Holdings owns and operates a global family of manufacturing and distribution businesses that together generate more than $20 billion in annual revenue. Atlas has experience in the office supplies sector through its LSC Communications unit, a leader in organizational solutions through brands such as Pendaflex.
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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.
The ODP Corporation (NASDAQ: ODP), parent company of Office Depot and OfficeMax, has entered into a definitive agreement to be acquired by an affiliate of Atlas Holdings in an all-cash transaction valued at approximately $1 billion. The deal, announced on September 22, 2025, represents a 34% premium to ODP’s closing share price on September 19 and will result in the company becoming privately held.
Under the terms of the agreement, ODP shareholders will receive $28 per share in cash. Once completed, shares of ODP common stock will be delisted from the NASDAQ exchange, marking a new chapter for the company as it transitions away from public markets.
The acquisition is expected to strengthen ODP’s business-to-business (B2B) operations, a core growth area that the company has prioritized in recent years. Through its subsidiaries—ODP Business Solutions, Office Depot, and Veyer—ODP provides an integrated platform that combines supply chain and distribution services with a nationwide retail footprint and omnichannel presence. This structure has positioned ODP as both a retailer and a strategic B2B service provider, a model that Atlas Holdings is expected to build upon.
Atlas Holdings, headquartered in Greenwich, Connecticut, is a diversified holding company that owns and operates 29 businesses across multiple industries, generating more than $20 billion in annual revenue. Its portfolio includes companies in automotive supply, building materials, food manufacturing, metals processing, packaging, printing, supply chain management, and more. With over 60,000 employees across 375 facilities worldwide, Atlas has a strong track record of investing in operational transformation and long-term growth strategies.
For ODP, this transaction provides not only a premium for shareholders but also resources to advance its ongoing shift from a traditional retail model toward a more technology-enabled, service-driven enterprise. In recent years, ODP has taken steps to navigate challenges in the retail environment by diversifying its revenue streams and sharpening its focus on providing solutions for business clients.
Becoming part of Atlas’s portfolio is expected to give ODP the flexibility to continue evolving without the quarterly pressures of public markets. Atlas’s experience in transitioning public companies into successful private enterprises is anticipated to provide the financial and operational support needed to accelerate ODP’s growth trajectory and reinforce its competitive position in the office supply and business services sector.
The transaction has been unanimously approved by ODP’s Board of Directors and is expected to close by the end of 2025, subject to customary regulatory and shareholder approvals.
If completed, the acquisition will represent one of Atlas Holdings’ most high-profile moves in recent years and could reshape the competitive landscape for B2B services and office supply distribution in North America.
Gold prices extended their rally on Monday, climbing to fresh record highs and setting the stage for what could be the precious metal’s best year in nearly half a century. Futures contracts rose to around $3,750 per ounce, while spot bullion held above $3,700. With a gain of more than 40% year-to-date, gold is on track for its most impressive annual performance since 1979.
The remarkable run has been fueled by a combination of macroeconomic forces, led by expectations of an extended Federal Reserve easing cycle. Last week, policymakers cut interest rates for the first time this year and signaled the likelihood of two more reductions before year-end. Lower rates typically enhance the appeal of gold, which does not generate yield, by reducing the opportunity cost of holding the asset.
A weakening U.S. dollar has added another layer of support. The dollar index, which tracks the greenback against a basket of major currencies, is down roughly 10% in 2025, giving gold buyers in other currencies stronger purchasing power. The dual dynamic of a softer dollar and looser monetary policy has created a powerful tailwind for the precious metal.
Investor demand has also been evident through record inflows into physically backed gold exchange-traded funds, which recently hit a three-year high. At the same time, central banks, particularly in emerging markets, have steadily expanded their reserves, increasing their reliance on gold as a hedge against currency volatility and shifting global trade dynamics.
Gold’s surge has easily outpaced traditional risk assets. The S&P 500 has gained about 13% this year, while bitcoin has advanced close to 20%. In contrast, gold’s rise above 40% underscores its position not only as a hedge during uncertain times but also as a top-performing asset class in 2025.
Fund manager sentiment reflects the divide between performance and positioning. A recent survey by Bank of America found gold now ranks as the second most crowded trade, just behind major U.S. technology stocks. Yet despite the recognition, the average allocation to gold among managers remains low at just over 2%, suggesting there could be room for further institutional participation.
Analysts remain constructive on the outlook. Goldman Sachs recently reiterated its view that gold could climb toward $4,000 per ounce by mid-2026, citing structural demand from ETFs, robust speculative interest, and accelerating central bank purchases. With geopolitical risks, trade uncertainty, and global monetary easing all converging, gold may continue to attract flows from investors seeking safety and diversification.
As 2025 heads into its final quarter, gold is not only outperforming but also reshaping how investors think about portfolio protection in a shifting economic landscape. Whether the momentum sustains into 2026 will depend on the trajectory of inflation, interest rates, and global risk appetite, but for now, gold is shining brighter than it has in decades.
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.
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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.
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.
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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.
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.
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.
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
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