Release – Nicola Mining Commences Shipping Of Gold Concentrate Under Partnership With Talisker Resources

Research News and Market Data on HUSIF

September 8, 2025

News Releases

VANCOUVER, BC, September 8, 2025 – Nicola Mining Inc. (the “Company” or “Nicola”) (TSX: NIM) (OTCQB: HUSIF) (FSE: HLIA) announces that it has commenced shipping of gold concentrate via a partnership with Talisker Resources Ltd. (TSX: TSK) (OTCQX: TSKFF) (“Talisker”). 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 extensive upgrades that included automation of several aspects of concentrate production, for the purpose of flotation recovery.  In addition, the Company’s installation of a large concentrator optimized free gold recovery, which is important for ore from Talisker and the Company’s Dominion Gold Project.  The Company confluence of numerous upgrades clearly impacted recovery and highlights Nicola’s ability to ramp up future production.

Pre-Processed Ore and Bagged Flotation Concentrate

Mr. Peter Espig, CEO of the Company, commented: “The culmination of our continuous multiple mill facility upgrades is the solidification of Nicola becoming a producer that is poised to benefit from gold and silver prices.  The Company continues to conduct work at its 100% of Treasure Mountain, a high-grade silver mine for which the mill was originally constructed.  The permitting and production of our partners highlights BC’s Ministry of Mining and Critical Minerals active support of smaller projects, for which we believe Nicola will become a hub.

Bagged Gravity Concentrate and Gravity Concentrate Close Up

About Nicola Mining

Nicola Mining Inc. is a junior mining company listed on the Exchange and Frankfurt Exchange that maintains a 100% owned mill and tailings facility, located near Merritt, British Columbia It has signed Mining and Milling Profit Share Agreements with high grade gold projects. Nicola’s fully permitted mill can process both gold and silver mill feed via gravity and flotation processes.

The Company owns 100% of the New Craigmont Project, a high-grade copper property, which covers an area of over 10,800 hectares along the southern end of the Guichon Batholith and is adjacent to Highland Valley Copper, Canada’s largest copper mine. The Company also owns 100% of the Treasure Mountain Property, which includes 30 mineral claims and a mineral lease, spanning an area exceeding 2,200 hectares.

On behalf of the Board of Directors

Peter Espig
Peter Espig CEO & Director

For additional information
Contact: Bill Cawker
Phone: (604) 649 0080
Email: info@nicolamining.com

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Release – FreightCar America, Inc. Adopts Limited Duration Stockholder Rights Plan

Research News and Market Data on RAIL

09/08/2025

Protects Long-Term Value for All Stockholders

CHICAGO, Sept. 08, 2025 (GLOBE NEWSWIRE) — FreightCar America, Inc. (NASDAQ: RAIL) (the “Company” or “FreightCar”) announced today that its Board of Directors (the “Board”) has adopted a limited duration stockholder rights plan (the “Rights Plan”) to protect the best interests of all FreightCar America, Inc. stockholders. The Rights Plan is effective immediately and will expire on August 5, 2026, unless terminated earlier by the Board.

The plan is intended to enable all stockholders to realize the long-term value of their investment and protect against any potential efforts to obtain control of the Company that are inconsistent with the best interests of its stockholders.

“Over the past several years, we have fully re-engineered our business and are now actively executing on a strategic plan to deliver substantial growth and long-term value creation. Following an analysis of our current position, the Board determined it was appropriate to adopt a rights plan to promote the fair and equal treatment of all the Company’s stockholders,” said Jim Meyer, Chairman of FreightCar America.

“We believe that there is significant upside ahead as we drive execution across our business, particularly given our leading margin profile and continued growth in market share,” said Nick Randall, President and Chief Executive Officer of FreightCar America. “Our management team is focused on advancing our commercial strategy with the inclusion of tank car conversions and other value-add solutions, while also continuing to support our flexible manufacturing model, which has proved itself to be a key competitive advantage for us and a hallmark of our approach.”

The Board adopted the Rights Plan following a review of the Company’s current ownership structure. The Rights Plan is intended to reduce the likelihood that any person or group gains control of the Company through open-market accumulation or other tactics without paying an appropriate control premium or providing the Board sufficient time to make informed decisions that are in the best interests of the Company and all FreightCar America stockholders. The Rights Plan is not intended to deter offers or preclude the Board from considering offers that are in the best interest of the stockholders.

About the Rights Plan
The Rights Plan is similar to plans adopted by other publicly-traded companies. In connection with the adoption of the Rights Plan, the Board of Directors declared a non-cash dividend distribution of one preferred share purchase right for each share of the Company’s common stock outstanding as of September 2, 2025, the record date. In general terms, the rights will become exercisable only if a person or group acquires 15% or more of the outstanding common stock of the Company without the approval of the Board (or 20% or more in the case of passive investors who are eligible to, and do, report their holdings on Schedule 13G). In the event that the rights become exercisable, each right will entitle stockholders (other than the acquiring person or group) to buy shares of FreightCar’s common stock at a 50% discount. The rights of the acquiring person or group in that event will become void and not exercisable.

This announcement is a summary only and is qualified by reference to the full text of the Rights Plan. Additional details regarding the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.

About FreightCar America

FreightCar America, headquartered in Chicago, Illinois, is a leading designer, producer and supplier of railroad freight cars, railcar parts and components. We also specialize in railcar repairs, complete railcar rebody services and railcar conversions that repurpose idled rail assets back into revenue service. Since 1901, our customers have trusted us to build quality railcars that are critical to economic growth and instrumental to the North American supply chain. To learn more about FreightCar America, visit www.freightcaramerica.com

Forward-Looking Statements

This press release contains statements relating to our expected financial performance, financial condition, and/or future business prospects, events and/or plans that are “forward-looking statements” as defined under the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our estimates and assumptions only as of the date of this press release. Our actual results may differ materially from the results described in or anticipated by our forward-looking statements due to certain risks and uncertainties. These risks and uncertainties relate to, among other things, the cyclical nature of our business; adverse geopolitical, economic and market conditions, including inflation; material disruption in the movement of rail traffic for deliveries; fluctuating costs of raw materials, including steel and aluminum; delays in the delivery of raw materials; our ability to maintain relationships with our suppliers of railcar components; our reliance upon a small number of customers that represent a large percentage of our sales; the variable purchase patterns of our customers and the timing of completion; delivery and customer acceptance of orders; the highly competitive nature of our industry; the risk of lack of acceptance of our new railcar offerings; potential unexpected changes in laws, rules, and regulatory requirements, including tariffs and trade barriers (including recent United States tariffs imposed or threatened to be imposed on China, Canada, Mexico and other countries and any retaliatory actions taken by such countries); and other competitive factors. The factors listed above are not exhaustive. New factors emerge from time to time that may cause our business not to develop as we expect, and it is not possible for us to predict all of them. We expressly disclaim any duty to provide updates to any forward-looking statements made in this press release, whether as a result of new information, future events or otherwise.

For more information, please contact:
RAILIR@Riveron.com

Primary Logo

Source: FreightCar America, Inc.

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Release – The ONE Group Hospitality, Inc. Appoints Nicole Thaung as Chief Financial Officer

Research News and Market Data on STKS

 Download as PDF September 08, 2025

Seven-Year Benihana CFO to Lead Accounting and Finance Organization

DENVER–(BUSINESS WIRE)– The ONE Group Hospitality, Inc. (“The ONE Group” or the “Company”) (Nasdaq: STKS) today announced the appointment of Nicole Thaung as Chief Financial Officer effective, September 8, 2025. Ms. Thaung will succeed Tyler Loy, who is departing the Company to pursue other opportunities.

“Nicole’s extensive financial knowledge and deep understanding of our business make her the ideal leader for our finance organization,” said Emanuel “Manny” Hilario, Chief Executive Officer. “Her leadership has been instrumental in the seamless integration of the Benihana acquisition. Nicole’s expertise will be invaluable as we continue realizing the $20 million in expected synergies from this transformative acquisition, which now represents over 55% of our total revenues. We remain on track to capture the full value of these synergies by the end of 2026.”

Ms. Thaung has over 15 years of experience with Benihana, where she has served as CFO since August 2018. Prior to her CFO role, Ms. Thaung held progressive leadership positions at Benihana including Vice President of Finance and Controller. Before joining Benihana in 2009, she spent nearly eight years at Ernst & Young LLP, with her last role being that of Audit Manager. Ms. Thaung holds bachelor’s and master’s degrees in accounting from the University of Florida.

“We thank Tyler for his contributions over the years with The ONE Group,” added Hilario. “We wish him success in his future endeavors.”

About The ONE Group

The ONE Group Hospitality, Inc. (Nasdaq: STKS) is an international restaurant company that develops and operates upscale and polished casual, high-energy restaurants and lounges and provides hospitality management services for hotels, casinos and other high-end venues both in the U.S. and internationally. The ONE Group’s focus is to be the global leader in Vibe Dining, and its primary restaurant brands and operations are:

  • STK, a modern twist on the American steakhouse concept with restaurants in major metropolitan cities in the U.S., Europe and the Middle East, featuring premium steaks, seafood and specialty cocktails in an energetic upscale atmosphere.
  • Benihana, an interactive dining destination with highly skilled chefs preparing food right in front of guests and served in an energetic atmosphere alongside fresh sushi and innovative cocktails. The Company franchises Benihanas in the U.S., Caribbean, Central America, and South America.
  • Benihana Express, a small footprint casual concept showcasing the best of Benihana but without teppanyaki tables or bar.
  • Kona Grill, a polished casual, bar-centric grill concept with restaurants in the U.S., featuring American favorites, award-winning sushi, and specialty cocktails in an upscale casual atmosphere.
  • RA Sushi, a Japanese cuisine concept that offers a fun-filled, bar-forward, upbeat, and vibrant dining atmosphere with restaurants in the U.S. anchored by creative sushi, inventive drinks, and outstanding service.
  • Salt Water Social is your gateway to the seven seas, featuring an array of signature and unique fresh seafood items, complemented by the highest quality beef dishes and elegant, delicious cocktails.
  • Samurai, an interactive dining experience located in sunny Miami, FL, provides a distinctive dining experience where skilled personal chefs masterfully perform the ancient art of teppanyaki right before your eyes.
  • ONE Hospitality, The ONE Group’s food and beverage hospitality services business develops, manages and operates premier restaurants and turnkey food and beverage services within high-end hotels and casinos currently operating venues in the U.S. and Europe.

Additional information about The ONE Group can be found at www.togrp.com.

Cautionary Statement on Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995, including with respect to the impact of the Benihana Inc. acquisition, restaurant openings and 2025 financial targets. Forward-looking statements may be identified by the use of words such as “target,” “intend,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. A number of factors could cause actual results or outcomes to differ materially from those indicated by such forward-looking statements, including but not limited to: (1) our ability to integrate the new or acquired restaurants into our operations without disruptions to operations; (2) our ability to capture anticipated synergies; (3) our ability to open new restaurants and food and beverage locations in current and additional markets, grow and manage growth profitably, maintain relationships with suppliers and obtain adequate supply of products and retain employees; (4) factors beyond our control that affect the number and timing of new restaurant openings, including weather conditions and factors under the control of landlords, contractors and regulatory and/or licensing authorities; (5) our ability to successfully improve performance and cost, realize the benefits of our marketing efforts and achieve improved results as we focus on developing new management and license deals; (6) changes in applicable laws or regulations; (7) the possibility that The ONE Group may be adversely affected by other economic, business, and/or competitive factors, including economic downturns; (8) the impact of actual and potential changes in immigration policies, including potential labor shortages; (9) the potential impact of the imposition of tariffs, including increases in food prices and inflation and any resulting negative impacts on the macro-economic environment; and (10) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K filed for the year ended December 31, 2024 and Quarterly Reports on Form 10-Q.

Investors are referred to the most recent reports filed with the Securities and Exchange Commission by The ONE Group Hospitality, Inc. Investors are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made, and we undertake no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Investors:
ICR
Michelle Michalski or Raphael Gross
(646) 277-1224
Michelle.Michalski@icrinc.com

Media:
ICR
Judy Lee
(646) 277-1242
judy.lee@icrinc.com

Source: The ONE Group Hospitality, Inc.

Released September 8, 2025

Gyre Therapeutics, Inc (GYRE) – Positioned To End YE2025 With Strong Products and Pipeline Development


Tuesday, September 09, 2025

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.

Gyre Has Made Strong YTD Progress. Gyre has made significant progress during the first three quarters of FY2025 that we believe positions the company for a strong year-end. These developments include continued sales growth from two products introduced in 1H25, an application for Hydronidone approval in China, and the start of a Phase 2 clinical trial for Hydronidone in the US. The company also announced the appointment of Dr. Han Ying as the new CEO, a member of the Board of Directors since January 2025.

Hydronidone Data Showed Efficacy and Proof of Concept. The pivotal Phase 3 trial testing Hydronidone in Chronic Hepatitis B-associated fibrosis has met its primary endpoint of fibrosis regression. The study was conducted in China, and an application for approval by the NMPA (the Chinese regulatory authority) is planned for 3Q2025. Hydronidone has received Breakthrough Therapy Designation, allowing for accelerated review. We expect approval in 2H2026, followed by launch in FY2027.


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US Jobs Revision Wipes Out 911,000 Positions, Raising Alarms About Economic Momentum

The U.S. labor market just got a reality check — and it’s a sobering one. A government revision revealed that the economy employed 911,000 fewer people as of March 2025 than initially reported, exposing a far weaker job market than policymakers and the public had believed. The new data, released by the Bureau of Labor Statistics (BLS), shows the slowdown began months before the summer headlines of weakening payrolls and rising unemployment.

The revision, covering the 12 months between March 2024 and March 2025, slashes average monthly job gains from an already modest 147,000 to just 71,000. For context, that’s less than half the pace originally reported and a figure that suggests the labor market was cooling long before the recent downturn. Economists had anticipated downward revisions, but the scale was startling — many expected about 700,000 fewer jobs, while the actual figure exceeded even the most pessimistic forecasts.

Industries that once looked like pillars of resilience proved more fragile under scrutiny. Leisure and hospitality was revised down by 176,000 jobs, erasing gains that had been touted as proof of post-pandemic recovery strength. Professional and business services followed with a downward revision of 158,000 jobs, signaling weakness in white-collar employment as well. Overall, the private sector absorbed the brunt, losing 880,000 jobs in the revision, while government payrolls were adjusted down by 31,000.

These annual revisions are routine, as the BLS incorporates more accurate data like unemployment insurance filings. But the magnitude of recent adjustments has been unusually large, feeding political tensions and raising questions about the reliability of initial reporting. Last year’s revision cut 818,000 jobs, landing right in the middle of the presidential campaign and fueling criticism from then-candidate Donald Trump.

Now, President Trump is in office and once again pointing to the BLS, accusing it of producing “phony” numbers. He has already dismissed the agency’s former commissioner and nominated E.J. Antoni, a vocal critic from the Heritage Foundation, to lead the bureau. Antoni’s confirmation battle will likely intensify after this revision, as the administration pushes for overhauls in how labor data is collected and reported.

Beyond politics, the numbers matter for the Federal Reserve, which is under pressure to respond to slowing job growth and signs of economic fragility. Trump and his allies argue Fed Chair Jerome Powell has been “too late” in cutting rates, claiming the central bank clung too rigidly to its 2% inflation target at the expense of growth. The White House could now use these revisions as further evidence to press its case.

For millions of Americans, though, the revisions underscore a more personal reality. A job market once presented as resilient is now revealed to have been much shakier. With fewer jobs than thought, weaker household income growth, and rising uncertainty, the labor market is entering a precarious phase. The debate in Washington may revolve around statistics, but the impact is being felt in homes and businesses across the country.

Unlocking Innovation & Market Scale: Key Opportunities in U.S. HCLS Acquisitions

In our previous article, we explored the strategic imperative behind European healthcare and life sciences (HCLS) companies and investors targeting the U.S. middle market. We highlighted the compelling valuations and the U.S.’s enduring role as a global growth and innovation engine. This time, we turn to the “WHAT” and “HOW”—the concrete strategic opportunities that await European acquirers in the dynamic U.S. HCLS landscape. Join us as we delve into the specific avenues through which European firms can unlock substantial value, from accessing the world’s deepest HCLS market to leveraging its unparalleled innovation ecosystems and diverse patient populations.

Accessing the World’s Deepest Market & Robust Growth

The sheer scale of the U.S. HCLS market remains a potent magnet for international capital. Representing over 40% of total global health spending and nearly 50% of global biopharma sales, the U.S. presents an immense operational footprint and growth trajectory rarely matched. For European companies, an acquisition here is more than just an expansion; it’s an immediate leap into the largest, most commercially mature healthcare arena. This article explores the specific, high-value opportunities that may result from European HCLS companies developing the US presence and how they can drive value going forward.

Despite some fluctuations in utilization rates, segments like Medicare Advantage continue to demonstrate robust growth, projected to expand by 5% annually through 2028. This provides a stable, expanding patient base for acquired entities, offering clear pathways for revenue generation and market penetration.

Tap into Dominant Biotech & Biopharma Innovation

The U.S. stands as the undeniable epicenter of biotech and biopharma innovation. Its vibrant ecosystems—think Boston/Cambridge, the San Francisco Bay Area, and the Research Triangle—are veritable hotbeds for pioneering clinical research, robust academic partnerships, and dynamic venture-backed startups. The biotech market alone is projected to grow from $1.74 trillion in 2025 to over $5 trillion by 2034, underscoring its explosive potential.

European acquirers can directly plug into these advanced networks, gaining access to cutting-edge R&D, intellectual property, and a pipeline of groundbreaking therapies. U.S.-based biopharmaceutical companies contribute 55% of global R&D investment, leading advancements in gene editing, mRNA vaccines, and precision medicine. Acquisitions provide a fast-track to these innovations, complementing Europe’s own scientific strengths.  Budget related changes to  government funding of HCLS research, will only increase the demand for private capital and keep downward pressure on valuations for earlier stage companies in the short term.   

Leverage Advanced Digital & AI Integration

The rapid adoption of digital health technologies and artificial intelligence (AI) across the U.S. healthcare system presents another transformative opportunity. The global AI  healthcare market is forecast to reach $110.61 billion by 2030, with North America holding the largest share and a high growth rate of 38.6% CAGR from 2025. This momentum translates into practical applications that European companies can acquire.

Over two-thirds of U.S. physicians utilized health AI in 2024, and 79% of healthcare organizations are actively integrating AI into their operations. This widespread adoption, from workflow optimization to predictive analytics and advanced diagnostics (with over 340 FDA-approved AI tools by 2025), offers European buyers a chance to acquire sophisticated digital capabilities, accelerating their own technological evolution and improving efficiency.

Access to Diverse Patient Populations for Clinical Advantage

The United States, with its highly diverse population, serves as an invaluable asset for clinical research and real-world data (RWD) generation. Acquiring a U.S. entity provides immediate access to a broad and varied patient base, crucial for conducting comprehensive clinical trials that reflect real world demographic variations. This diversity is vital for ensuring the safety and efficacy of new treatments across different genetic backgrounds, ages, and ethnicities.

Beyond traditional trials, the U.S. market’s extensive data infrastructure and growing emphasis on RWD allow for more robust post-market surveillance and the development of personalized medicine approaches. European firms can leverage this to refine therapies, expand indications, and accelerate market access.

Gaining A Foothold in a Mature, High-Value Commercial Landscape

  • An acquisition in the U.S. offers European HCLS companies more than just innovation; it provides immediate entry into a mature, high-value commercial landscape. This includes established distribution networks, robust sales infrastructures, and direct access to a complex yet lucrative multi-payer reimbursement system. While navigating the  distinct U.S. market access landscape can be challenging compared to European models, a well-executed acquisition provides a foundational platform from which to optimize commercial strategies and capture significant revenue streams. FDA has served as a quasi-Global Benchmark. U.S. FDA approvals often set the standard for global market entry. Acquisitions and licensing U.S. assets can streamline regulatory pathways in other regions and offer faster times to market utilizing the FDA’s relatively agile regulatory frameworks (e.g., accelerated approval, breakthrough therapy designation).

This integration allows European acquirers to bypass years of organic market development, capitalizing on existing brand recognition, patient relationships, and regulatory approvals. U.S. biotech attracts over 60% of global biotech VC funding, providing acquired firms with greater access to follow-on capital. The U.S. has a mature biotech capital market and companies are acquisition-ready or near IPO-stage, offering clear exit strategies. Companies with US based assets advancing under the FFDA regulatory process are more likely to obtain access to US based biotech VC funding. US VC’s may have a propensity to rely on FDA standards as a benchmark for clinical success globally and access to a robust US commercial market.

Connecting Opportunities: How These Elements Combine for European Buyers

The strategic opportunities in U.S. HCLS are synergistic. For instance, a European biopharma firm might acquire a U.S. biotech startup not only for its innovative pipeline but also for its access to a major U.S. innovation cluster, a diverse patient cohort for future trials, and an existing network for commercialization. This “string-of-pearls” approach—acquiring smaller, specialized companies to build a larger presence—has been a major driver of several recent major deals involving targeted acquisitions that fill specific capability gaps and accelerate growth.

Recent examples, such as Denmark’s Novo Holdings acquiring U.S. CDMO giant Catalent and Swiss Alcon’s acquisition of U.S. medtech firm Lensar, underscore this trend. These deals provide examples of European companies strategically investing in the US to gain manufacturing capabilities, innovative product lines, and direct market access.

Conclusion

The U.S. HCLS market presents unparalleled strategic opportunities for European companies and investors. Beyond the attractive valuations discussed in Article 1, the ability to directly access its vast market scale, dominant innovation ecosystems, advanced digital integration, and diverse patient populations offers a compelling “WHAT” for transatlantic M&A. This is not merely about expansion but about transformative growth and competitive advantage.

In our next article, we will delve into the “HOW” of successful transatlantic M&A, focusing on the critical talent edge and operational synergies necessary for seamless integration and long-term value creation.


About the Authors:

Nathan Cali is a Managing Partner at Noble Capital Markets with more than 18 years of Capital Markets experience. He has been a lead Managing Director/Head of the Healthcare and Life Sciences Investment Banking and Advisory franchise at NOBLE since 2017 and was previously a sell-side equity analyst for 9 years. Nathan is a Board Member of Precise Bio, a tissue engineering, biomaterials, and cell technologies company, including cardiology, orthopedics, and dermatology. He was previously a board observer of Eledon Pharmaceuticals (ELDN:NASDAQ, f.k.n.a. Anelixis Therapeutics, Inc.), a phase II biotechnology company. Prior to joining NOBLE, Nathan gained investment experience as a portfolio account analyst/manager at Franklin Templeton Investments. Nathan also currently holds series 7, 79, 86, and 87 FINRA designations.

Hinesh Patel, MCMI ChMC is a Partner in CNM LLP’s Los Angeles Office with over 20 years of experience in accounting. He leads and oversees the firm’s Accounting and Transaction Advisory practice. He brings a vast knowledge of US GAAP, technical accounting, and International Financial Reporting Standards (IFRS) reporting requirements to his role at CNM. Hinesh primarily focuses on technical accounting, IPO readiness, SEC reporting, and mergers and acquisitions. Prior to joining CNM, Hinesh worked as a Senior Manager at Deloitte with a primary focus in the technology, manufacturing, consumer business and entertainment industries for both public and private companies. He has assisted various companies through the IPO process and advised on a range of accounting services including technical accounting, financial reporting, and new business processes requirements.

Matthew (Matt) Podowitz is the founder and Principal Consultant of Pathfinder Advisors LLC, bringing experience on 400+ global M&A engagements to his clients. He specializes in the critical operational and technology aspects of M&A transactions, providing due diligence, carve-out, integration, and value creation services. Known for practical, actionable advice derived from extensive hands-on experience with healthcare and life sciences transactions, Matt helps companies, investment banks, and private equity firms navigate complex cross-border HCLS M&A through every step of the transaction lifecycle. Leveraging his perspective as a dual US/EU citizen, he provides seamless support for transactions in both markets. His background includes leadership roles at firms like Ernst & Young, Grant Thornton, and CFGI.

Chris Raphaely is the Co-Chair of Cozen O’Connor’s Health Care & Life Sciences Practice where he provides sophisticated transactional and regulatory counsel to an array of health care providers and investors in the health care industry. His practice focuses on mergers, acquisitions, and divestiture transactions for health care clients and the comprehensive regulatory schemes requisite to doing business in the health care space. Chris routinely handles matters involving payer negotiations, payment disputes and contract enforcement, accountable care organizations, management services organization, clinically integrated networks, value based payment arrangements, pharmacy benefit management and third party administrator contracts for self-insured employers, digital health, organizational and governance structures, HIPAA, information privacy and security, tax exemption, Stark Law, fraud and abuse matters, clinical integration, medical staff relations, facility and professional licensing, Pennsylvania’s Medical Marijuana Act, and general compliance. Prior to joining the firm, Chris served as the deputy general counsel to Jefferson Health System and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

Nebius Stock Soars on $19B Microsoft AI Deal, Underscoring AI Infrastructure Boom

Nebius Group’s stock price skyrocketed this week after the Amsterdam-based artificial intelligence infrastructure firm announced a multi-year partnership with Microsoft worth up to $19.4 billion. The deal highlights the surging demand for GPU-powered cloud computing capacity and underscores the critical role infrastructure providers play in supporting the global AI boom.

Shares of Nebius, which was spun out of Russian internet company Yandex in 2023, surged more than 40% on Tuesday following the announcement. The rally came on top of a 60% spike in extended trading Monday, marking one of the steepest short-term gains for an AI-related stock in 2025. Under the agreement, Nebius will supply Microsoft with graphics processing units (GPUs) and computing power valued at $17.4 billion through 2031. Microsoft may also secure additional capacity, potentially bringing the total value of the contract to $19.4 billion.

The Nebius-Microsoft deal instantly positions the European company as a top-tier supplier of AI cloud infrastructure. GPUs are essential for training and scaling large language models, generative AI platforms, robotics, and other advanced artificial intelligence applications. As enterprises race to deploy AI, demand for this specialized hardware has grown far faster than traditional cloud services. For Microsoft, the agreement ensures Azure customers, OpenAI projects, and its own AI-powered products have the computing resources required to expand.

This partnership also shows that while Nvidia remains the leader in AI chips, competition is opening up. Nebius joins a growing roster of infrastructure providers—including CoreWeave, which saw its shares climb 8% on the news—benefiting from hyperscalers’ urgent need to lock in GPU supply. Investors see this as a sign that AI infrastructure spending could remain strong despite market concerns about inflated valuations.

Analysts note that the deal comes amid broader predictions of enormous long-term spending on AI hardware. Nvidia executives recently forecast that between $3 trillion and $4 trillion will flow into AI infrastructure globally by 2030. At the same time, some experts, including OpenAI CEO Sam Altman, have warned of a possible AI bubble as valuations for startups like Anthropic and OpenAI itself reach record highs. Nebius’s surge reflects the optimism that demand will outweigh bubble risks, at least for infrastructure suppliers.

For Nebius, the Microsoft partnership provides not only revenue security through 2031 but also credibility as a global player in the AI race. By aligning with one of the world’s largest technology companies, Nebius strengthens its position in a market where trust, scale, and performance are paramount.

The stock market response suggests investors believe infrastructure will be one of the most resilient segments of the artificial intelligence economy. While software companies may face volatile valuations, firms that deliver the backbone of AI workloads—GPUs, cloud data centers, and compute resources—are emerging as long-term winners. With its $19 billion deal, Nebius has firmly secured its spot in the spotlight.

U.S. Oil Industry Faces Layoffs and Spending Cuts as Lower Prices Threaten Output Growth

The U.S. oil industry is facing a sharp slowdown, with layoffs and spending cuts rippling across the sector as lower crude prices and industry consolidation squeeze margins. The wave of belt-tightening could mark the end of the rapid production growth that helped the United States overtake other producers to become the world’s top oil supplier in recent years.

International crude prices have fallen roughly 12% this year, dragged lower in part by rising output from OPEC and its allies, who have been steadily ramping up supply to reclaim market share lost to U.S. shale producers. Prices are now hovering just above $62 a barrel, uncomfortably close to breakeven levels for many U.S. operators. For companies already grappling with higher costs and trade-related tariffs, the weaker pricing environment is forcing tough decisions.

ConocoPhillips, the nation’s third-largest oil producer, recently announced plans to cut up to a quarter of its workforce. The move follows Chevron’s decision earlier this year to trim about 20% of its staff, amounting to roughly 8,000 jobs. Oilfield service providers such as SLB and Halliburton have also been cutting jobs, underscoring how the slowdown is spreading beyond producers to the broader energy ecosystem.

The cuts aren’t limited to people. According to a Reuters review of second-quarter results, 22 publicly traded U.S. producers—including ConocoPhillips, Diamondback Energy, and Occidental Petroleum—have reduced their combined capital spending by about $2 billion. Industry insiders say those pullbacks, along with falling rig counts, are early warning signs that production growth is set to level off. Baker Hughes data shows that the U.S. oil rig count has dropped by nearly 70 so far this year, down to just over 400.

In the Permian Basin, the heart of America’s shale boom, the tone has shifted from aggressive expansion to cautious retrenchment. “We’ve gone from ‘drill, baby, drill’ to ‘wait, baby, wait,’” said one Texas producer, pointing out that prices need to stabilize closer to $70–$75 a barrel before rig activity rebounds. Without that, analysts warn that U.S. output will plateau and could even begin to decline, with OPEC quickly stepping in to fill the gap.

Research firms are already forecasting slower momentum. Energy Aspects expects U.S. onshore production to drop by 300,000 barrels per day in 2025, while Wood Mackenzie projects only modest growth of 200,000 barrels per day—far below the record-setting pace of recent years.

Adding to the pressure are rising costs, much of it tied to tariffs on steel and other inputs. Diamondback Energy expects the price of steel casing for wells to climb by nearly 25% this year, inflating breakeven costs across the industry. For ConocoPhillips, controllable costs have already risen by $2 per barrel since 2021, making profitability harder to sustain.

The impact on employment is significant. Texas labor data shows U.S. oil and gas production jobs fell by nearly 5,000 in the first half of 2025, while energy services jobs have dropped by about 23,000 since January. Even with gains in drilling efficiency, industry analysts caution that technology alone won’t be enough to offset the slowdown.

For now, the U.S. oil industry remains a global leader. But with lower prices, higher costs, and fewer rigs in action, the sector’s once-rapid growth story appears to be entering a more uncertain chapter.

Release – Tonix Pharmaceuticals Presents Clinical Data on Tonmya™ for the Treatment of Fibromyalgia at PAINWEEK 2025

Research News and Market Data on TNXP

September 08, 2025 7:00am EDT Download as PDF

Tonmya was approved by FDA on August 15, 2025 for the treatment of fibromyalgia and is the first new FDA approved treatment for fibromyalgia in over 15 years

Two pivotal Phase 3 studies demonstrated Tonmya significantly reduced fibromyalgia pain compared to placebo

Tonmya showed consistent improvements across core fibromyalgia symptoms, including widespread pain, sleep disturbance and fatigue

Tonmya was well tolerated, supporting its potential as a long-term treatment option for fibromyalgia

Tonmya is expected to be commercially available in the fourth quarter

CHATHAM, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, presented four posters at the PAINWEEK conference 2025, held September 2-5, 2025, in Las Vegas, Nevada entitled:

  • “TNX-102 SL, Cyclobenzaprine HCl Sublingual Tablets, Demonstrates Pain Reduction and Favorable Tolerability in Participants With Fibromyalgia”
  • “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials”
  • “Steady-state Pharmacokinetic Properties of a Sublingual Formulation of Cyclobenzaprine (CBP) HCl (TNX-102 SL): Comparison to Simulations of Oral immediate-release CBP”
  • “Randomized, Double-Blind, Placebo-Controlled Confirmatory Phase 3 Trial of Bedtime Sublingual Cyclobenzaprine (TNX-102 SL) in Fibromyalgia”

“Fibromyalgia is a chronic and debilitating condition marked by widespread pain, poor sleep, and fatigue and cognitive dysfunction,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “The data presented at PAINWEEK show that Tonmya significantly improved pain with a favorable tolerability profile, offering patients and physicians a new, non-opioid treatment option. Now that Tonmya has been approved by FDA, we believe we are well-positioned to execute the launch and remain on track to deliver this drug to patients next quarter.”

The posters included data from two pivotal Phase 3 trials: RELIEF, a 14-week randomized, double-blind, placebo-controlled study of TNX-102 SL 5.6 mg (now Tonmya™), and RESILIENT, a confirmatory trial evaluating efficacy and safety. Across both studies, Tonmya significantly reduced fibromyalgia pain and demonstrated a favorable tolerability profile. By pharmacologically targeting nonrestorative sleep through antagonism of receptors that regulate sleep architecture, Tonmya engages a central mechanism believed to drive the persistence of fibromyalgia symptoms. The availability of a safe and well-tolerated treatment may also support earlier diagnosis and intervention, ultimately improving patient outcomes. Together, these findings suggest Tonmya has the potential to improve a broad spectrum of fibromyalgia symptoms.

Copies of the posters are available under the Scientific Presentations tab of the Tonix website at www.tonixpharma.com.

About Fibromyalgia
Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 10 million adults in the U.S., approximately 80% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep (waking up tired and unrefreshed), fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Patients with fibromyalgia have double the medical costs compared to the general population in the U.S.

About Tonmya™ (cyclobenzaprine HCl sublingual tablets)
Tonmya, which was investigated as TNX-102 SL, is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride, which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of 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, Tonmya is now approved as a once-daily bedtime treatment for fibromyalgia in adults. 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.

About the Phase 3 Clinical Trials: RELIEF, RALLY and RESILIENT
The RELIEF and RESILIENT studies were double-blind, randomized, placebo-controlled trials designed to evaluate the efficacy and safety of Tonmya™ (cyclobenzaprine hydrochloride sublingual tablets) for the treatment of fibromyalgia. RELIEF and RESILIENT were two-arm trials that enrolled 503 and 457 adults with fibromyalgia across 40 and 33 United States sites, respectively. In both trials, the first two weeks of treatment consisted of a run-in period in which participants started on Tonmya 2.8 mg (1 tablet) or placebo. Thereafter, all participants increased their dose to Tonmya 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint across both trials was the daily diary pain intensity score change (Tonmya 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores). Additional details on RELIEF (NCT04172831) and RESILIENT (NCT05273749) are available on clinicaltrials.gov.

RALLY was a replicate Phase 3 trial to RELIEF and RESILIENT that demonstrated greater but non-significant treatment effect with Tonmya compared to placebo and demonstrated consistent safety. Results of this trial may not have been generalizable due to the presence of factors outside the conduct of the study. Additional details are available on clinicaltrials.gov (NCT04508621).

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 TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology 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 obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our 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.

Investor Contact
Jessica Morris
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 799-8599

Brian Korb
astr partners
brian.korb@astrpartners.com
(917) 653-5122

Media Contact
Ray Jordan
Putnam Insights
ray@putnaminsights.com
(949) 245-5432

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.

Primary Logo

Source: Tonix Pharmaceuticals Holding Corp.

Released September 8, 2025

Release – V2X Names Greg Lundy Vice President of Technology

V2X (PRNewsfoto/V2X, Inc.)

Research News and Market Data on VVX

September 08, 2025

RESTON, Va., Sept. 8, 2025 /PRNewswire/ — V2X, Inc. (NYSE: VVX) today announced the appointment of Greg Lundy as Vice President of Technology, effective immediately. In this role, Lundy will lead the company’s innovation and technology strategy, with a focus on advancing Independent Research and Development initiatives. He will report directly to L. Roger Mason, Chief Growth Officer at V2X.

Lundy brings more than 20 years of leadership experience at the intersection of artificial intelligence, machine learning, cybersecurity, and advanced network architectures. He joins V2X from Collins Aerospace and has also held senior roles with Sony, Booz Allen Hamilton, and the U.S. Navy.

“Greg has a proven track record of driving multibillion-dollar defense and aerospace portfolios, architecting secure and autonomous systems, and leading large-scale engineering teams,” said Jeremy C. Wensinger, President and Chief Executive Officer at V2X. “As a former U.S. Navy officer and mission commander with more than 2,000 combat flight hours and deep operational ISR expertise, he brings mission-critical focus and technical leadership that will strengthen our innovation strategy and support our customers’ most complex challenges.”

Lundy holds a bachelor’s degree from the Maine Maritime Academy, a master’s degree from The George Washington University, an MBA from the University of Virginia’s Darden School of Business, and a doctorate in Artificial Intelligence/Machine Learning from The George Washington University.

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@oV2X.com
571-338-5195

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/v2x-names-greg-lundy-vice-president-of-technology-302548934.html

SOURCE V2X, Inc.

Release – Cocrystal Pharma Receives FDA IND Clearance for Challenge Study of Oral Broad-Spectrum Protease Inhibitor CDI-988, a Potential First Antiviral for Norovirus Prevention and Treatment

Research News and Market Data on COCP

September 08, 2025

 Download as PDF

  • There are currently no approved vaccines or treatments for norovirus infection
  • Cocrystal’s CDI-988 is the first antiviral for the potential prevention and treatment of viral gastroenteritis caused by norovirus infections
  • Phase 1b study is expected to start by year-end 2025

BOTHELL, Wash., Sept. 08, 2025 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the Company received a Study May Proceed Letter from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1b challenge study evaluating CDI-988 for the prevention and treatment of norovirus infections. Cocrystal’s oral broad-spectrum antiviral candidate CDI-988 represents a potential breakthrough for norovirus – the most common cause of acute viral gastroenteritis. The Phase 1b challenge study is planned to begin before year-end 2025.

CDI-988 is a novel pan-viral 3CL protease inhibitor developed for the treatment of norovirus and coronavirus infections. Preclinical data demonstrate that CDI-988 exhibits broad-spectrum antiviral activity by targeting a highly conserved region in the active site of the viral proteases. CDI-988 has shown effectiveness against major norovirus proteases including the prevalent GII.4 and GII.17. Data from the Phase 1 study showed oral CDI-988 to be well tolerated with a favorable safety profile. Currently, there are no approved vaccines or therapeutics for norovirus infections.

“The FDA’s clearance of our CDI-988 study is an important milestone for Cocrystal and marks a significant step in advancing to the next stage of its clinical development. CDI-988 is the first novel, oral drug candidate for the prevention and treatment for norovirus infection and has demonstrated impressive data to date with broad antiviral activity,” said Sam Lee, PhD, President and co-CEO of Cocrystal Pharma. “We look forward to the planned initiation of our Phase 1b challenge study and further determining the potential efficacy of CDI-988 in norovirus-infected patients.”

About Norovirus
Norovirus infections affect millions globally, spreading rapidly through direct contact and contaminated food and surfaces. The virus is particularly problematic in confined environments such as cruise ships, hospitals, and military facilities. In the U.S., norovirus causes an estimated 21 million infections annually, including 109,000 hospitalizations, 465,000 emergency department visits and an estimated 900 deaths. Vulnerable populations, including infants, elderly and those immuno-compromised, can face more severe and prolonged infections. Individuals can remain contagious for weeks after symptoms are resolved, complicating containment efforts.

Cocrystal Structure-Based Platform Technology
CDI-988 leverages Cocrystal’s proprietary structure-based drug discovery platform, which provides three-dimensional visualization of inhibitor complexes at near-atomic resolution. This technology enables rapid identification of novel drug binding sites and accelerates the development of broad-spectrum antivirals for the treatment of acute and chronic viral diseases.

About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company that addresses significant unmet needs by developing innovative antiviral treatments for challenging diseases including influenza, viral gastroenteritis, COVID, and hepatitis. Cocrystal employs unique structure-based technologies to create first- and best-in-class antiviral drugs.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding our plans to initiate a human Phase 1b challenge study for our norovirus product candidate. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the ability of our clinical research organization to recruit volunteers for, and to otherwise proceed with the challenge study, our contract manufacturing organization’s ability to produce the products needed for the study, geopolitical conflicts including those in Ukraine and Israel on our Company, our collaboration partners, and on the U.S., economy, including manufacturing and research delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with the study, and our ability to meet our liquidity needs. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2024. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
Alliance Advisors IR
Jody Cain
310-691-7100
jcain@allianceadvisors.com

# # #

Primary Logo

Source: Cocrystal Pharma, Inc.

Released September 8, 2025

Release – Newsmax: Carl Higbie to Lead Key 6:00 PM Hour

Research News and Market Data on NMAX

September 8, 2025

BOCA RATON, FL / ACCESS Newswire / September 8, 2025 / Newsmax Inc. (NYSE:NMAX) (“Newsmax” or the “Company”) today announced a strategic realignment of its weekday evening schedule, boosting the Company’s late daytime lineup ahead of a pivotal moment in the day.

Starting Monday, September 8, 2025, Carl Higbie will move into the 6:00pm ET slot to host Carl Higbie FRONTLINE, anchoring viewers’ transition from day to night with incisive news analysis, fearless reporting and provocative opinion.

Veteran journalist Greta Van Susteren will pivot from the 6:00pm ET hour to a newly powerful 4:00pm ET timeslot, positioning her at the heart of momentous breaking stories as the market closes, court hearings end and Congress adjourns.

With decades of experience in delivering sharp, fact-based analysis and piercing interviews, Van Susteren’s move underscores Newsmax’s commitment to timely and authoritative journalism.

Simultaneously, The Chris Salcedo Show will shift into the 5:00pm ET hour, continuing his unapologetically conservative commentary in the critical early evening timeframe.

Carl Higbie Takes Evening Lead

Former U.S. Navy SEAL and seasoned political commentator Carl Higbie has been a dynamic presence at Newsmax since launching Carl Higbie FRONTLINE in April 2023.

Now airing at 6:00pm ET, the program adopts a sharper night-time edge, characterized by Higbie’s trademark “fearless exposure of government overreach and sharp critique of the mainstream media” – designed to kick off evening viewing powerfully.

Higbie made headlines in August when Carl Higbie FRONTLINE broadcast from Israel for a full week. Reporting from Jerusalem and other key locations, he provided coverage of Israel’s security concerns, touring defense industries and speaking directly with officials such as Israel’s Prime Minister Benjamin Netanyahu.

Christopher Ruddy, CEO of Newsmax, praised the lineup innovation: “This reshuffle is designed to meet our viewers when the news truly matters,” Ruddy said. “Carl is a bold, unafraid journalist; Greta brings unmatched credibility at a critical juncture; and Chris brings strong voice and insight – together they form a powerful trifecta. We believe this revamped lineup will strengthen our connection with a news-hungry audience as we lead into primetime.”

New Late Day Lineup (Effective September 8, 2025)

  • 4:00pm ETThe Record with Greta Van Susteren
  • 5:00pm ETThe Chris Salcedo Show
  • 6:00pm ETCarl Higbie FRONTLINE
  • 7:00pm ET: Rob Schmitt Tonight
  • 8:00pm ET: Finnerty
  • 9:00pm ET: Greg Kelly Reports
  • 10:00pm ET: The Right Squad

About Newsmax
Newsmax Inc. is listed on the NYSE (NMAX) and operates, through Newsmax Broadcasting LLC, one of the nation’s leading news outlets, the Newsmax channel. The fourth highest-rated network is carried on all major pay TV providers. Newsmax’s media properties reach more than 40 million Americans regularly through Newsmax TV, the Newsmax App, its popular website Newsmax.com, and publications such as Newsmax Magazine. Through its social media accounts, Newsmax reaches 20 million combined followers. Reuters Institute says Newsmax is one of the top U.S. news brands and Forbes has called Newsmax “a news powerhouse.”

For more information, please visit Investor Relations | Newsmax Inc.

Investor Contacts
Newsmax Investor Relations
ir@newsmax.com

SOURCE: Newsmax Inc.

Bit Digital (BTBT) – Monthly Ethereum Treasury and Staking Metrics


Monday, September 08, 2025

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.

Data. Bit Digital reported its monthly Ethereum (“ETH”) treasury and staking metrics for the month of August 2025. As of August 31, 2025, the Company held approximately 121,252 ETH, including approximately 15,084 ETH and ETH-equivalents held in an externally managed fund, and approximately 5,094 ETH presented on an as-converted basis from LsETH using the Coinbase conversion rate as of 8/31/25. The Company’s total staked ETH was approximately 105,031 as of August 31st.

Yield and Value. Staking operations generated approximately 249 ETH in rewards during August, representing an annualized yield of approximately 2.94%. Based on a closing ETH price of $4,391.91, as of August 31, 2025, the market value of the Company’s ETH holdings was approximately $532.5 million.


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