Snail is a leading, global independent developer and publisher of interactive digital entertainment for consumers around the world, with a premier portfolio of premium games designed for use on a variety of platforms, including consoles, PCs and mobile devices.
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Solid Q4 results. The company reported Q4 revenue and adj. EBITDA of $26.2 million and $1.6 million, respectively. While revenue was modestly better than our estimate of $25.0 million, adj. EBITDA was a tad softer. Notably, the variance in adj. EBITDA was driven by an increased focus on in-house development, resulting in higher R&D costs. We view the company’s efforts to diversify its revenue stream as a favorable development.
Portfolio expansion. The company has been taking steps to offer more games and products that could drive revenue diversification. Notably, the company launched ARK: Ultimate Mobile Edition in December and gained over 2 million users during the month. Additionally, the company soft launched a new mobile app, SaltyTV, which offers original short film content. Furthermore, the company acquired eleven games in 2024, with several releases expected in 2025.
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Key Points: – Braze is acquiring AI decisioning company OfferFit for $325 million. – OfferFit’s reinforcement learning technology will enhance Braze’s AI-powered personalization. – The acquisition supports Braze’s vision for AI-driven customer engagement and experimentation.
Braze (Nasdaq: BRZE), a leading customer engagement platform, has announced its acquisition of OfferFit, an AI decisioning company, for $325 million. The acquisition, expected to close by the end of July 2025, represents a significant step in Braze’s mission to enhance AI-powered personalization, customer journey optimization, and marketing automation.
OfferFit specializes in AI decisioning agents that replace traditional A/B testing with reinforcement learning, allowing brands to automate experimentation and optimize customer interactions in real time. By integrating OfferFit’s technology into its platform, Braze aims to accelerate the evolution of AI-driven engagement, enabling brands to deliver more relevant and personalized customer experiences across multiple channels.
A New Era of AI-Powered Customer Engagement
Braze has long been at the forefront of AI-driven marketing, using machine learning and automation to refine customer interactions. In September 2024, the company introduced Project Catalyst, an initiative designed to leverage AI agents for personalizing customer journeys, content, and incentives. OfferFit’s multi-agent AI system will further enhance these efforts, helping Braze create an even more intelligent and adaptive marketing platform.
“From the beginning, our real-time stream processing technology differentiated Braze’s modern approach to cross-channel customer engagement,” said Braze CEO Bill Magnuson. “Now, with OfferFit’s reinforcement learning technology, we’re taking another leap forward. AI decisioning agents will help brands automatically understand customer behavior, engage them more effectively, and strengthen relationships through intelligent optimization.”
OfferFit has already demonstrated significant success in the AI-driven personalization space. Brands using its technology have seen improved marketing performance by customizing outreach based on hundreds of unique characteristics. For example, companies have used OfferFit’s AI to optimize reactivation campaigns for inactive users or personalize emails to increase new customer signups.
Strategic Benefits and Industry Implications
With this acquisition, Braze is positioning itself as a leader in AI-powered customer engagement at a time when marketers are increasingly turning to automation and machine learning to drive results. OfferFit’s expertise will allow Braze to provide more sophisticated AI-powered tools, helping businesses move beyond manual segmentation and A/B testing to truly individualized marketing strategies.
OfferFit CEO George Khachatryan emphasized the alignment between the two companies. “Like Braze, OfferFit was built to apply advanced technology to the hardest problems that marketers face,” he said. “As a long-time technology partner of Braze, we knew our products were complementary. This acquisition will allow us to scale our AI decisioning technology more rapidly and bring even greater value to Braze’s global customer base.”
Under the terms of the agreement, Braze will acquire OfferFit in a cash and stock transaction. Goldman Sachs & Co. LLC is serving as financial advisor to Braze, with Davis Polk & Wardwell LLP providing legal counsel. OfferFit is being advised by Atlas Technology Group and Latham & Watkins LLP.
The acquisition highlights Braze’s commitment to AI innovation, reinforcing its position as a key player in the rapidly evolving marketing technology landscape. Investors and industry stakeholders will gain further insights during Braze’s Fourth Quarter Fiscal Year 2025 Financial Results Conference Call. As AI continues to reshape marketing, this acquisition signals a new chapter in customer engagement, where automation, data-driven insights, and personalization take center stage.
NEW YORK–(BUSINESS WIRE)– Perfect Corp. (NYSE: PERF) (“Perfect” or the “Company”), a global leader in providing augmented reality (“AR”) and artificial intelligence (“AI”) solutions to consumers, beauty and fashion industries, today announced that it filed its annual report on Form 20-F for the fiscal year ended December 31, 2024. The annual report can be accessed under the SEC Filing section on the Company’s investor relations website at https://ir.perfectcorp.com.
The Company will provide a hard copy of its annual report containing the audited consolidated financial statements, free of charge, to its shareholders upon request. Requests should be directed to 14F, No. 98 Minquan Road, Xindian District, New Taipei City 231, Taiwan, or via email at Investor_Relations@PerfectCorp.com.
About Perfect Corp.
Perfect Corp. (NYSE: PERF) leverages ‘Beautiful AI’ innovations to make our world more beautiful. As a pioneer and leader in the space, Perfect Corp. works with over 650 partners around the globe to empower brands to embrace the digital-first world by transforming shopping journeys through digital tech innovations. Perfect Corp.’s suite of enterprise solutions delivers synergistic, technology-driven experiences that facilitate sustainable, ultra-personalized, and engaging shopping journeys through hyper-realistic virtual try-ons, AI-powered skin analyses, personalized product recommendation tools and many more Beautiful AI innovations. For more information, visit https://ir.perfectcorp.com.
Key Points: – Core inflation rose 2.8% in February, exceeding expectations, while consumer spending increased 0.4%. – Consumer sentiment dropped to its lowest level since 2022, with growing fears about the labor market. – The Federal Reserve remains cautious on rate cuts as inflation remains above its 2% target.
The U.S. economy continues to face challenges as inflation remains higher than expected while consumer sentiment has dropped to its lowest level in more than two years. Recent data from the Commerce Department and the University of Michigan highlight ongoing concerns about rising prices, slowing consumer spending, and a weakening labor market.
The Federal Reserve’s preferred inflation measure, the core Personal Consumption Expenditures (PCE) price index, rose 0.4% in February, bringing the annual rate to 2.8%. Both figures exceeded economists’ expectations, marking the biggest monthly gain since early 2024. The broader PCE index, which includes food and energy, rose 0.3% on the month and 2.5% year-over-year, in line with forecasts. Goods prices increased 0.2%, led by recreational goods and vehicles, while services prices climbed 0.4%. Gasoline prices provided some relief, declining 0.8%.
Consumer spending increased 0.4% in February, slightly below the 0.5% forecast, despite a stronger-than-expected rise in personal income of 0.8%. While Americans are earning more, they remain cautious about their spending, with the personal savings rate rising to 4.6%, the highest level since June 2024. The stock market reacted negatively to the inflation data, with futures briefly declining as investors weighed the possibility of prolonged higher interest rates.
At the same time, consumer sentiment has weakened. The University of Michigan’s sentiment index fell to 57 in March, the lowest reading since November 2022. A key measure of consumer expectations for the economy dropped to 52.6, signaling growing uncertainty about financial conditions. Labor market concerns are increasing, with two-thirds of consumers expecting unemployment to rise in the coming year, the highest level since 2009. While February’s job report showed 151,000 jobs added and an unemployment rate of 4.1%, underlying data suggests hiring may be slowing. Indicators such as declining job postings and fewer workers voluntarily leaving jobs point to reduced confidence in the labor market.
The Federal Reserve now faces a difficult decision. After cutting rates by a full percentage point in 2024, the central bank has held off on further moves this year. Policymakers are closely monitoring inflation, particularly as President Trump’s proposed tariffs could increase costs across multiple sectors. While tariffs are generally viewed as one-time price shocks rather than ongoing inflationary forces, the scope of Trump’s trade policies and the potential for a broader trade war add uncertainty to the outlook.
For now, the Fed is likely to maintain its cautious stance, balancing inflation concerns with signs of weakening consumer confidence and labor market risks. If economic conditions deteriorate further, discussions around potential rate cuts may gain traction. However, as inflation remains above the central bank’s 2% target, policymakers are hesitant to move too quickly.
With inflation pressures persisting and consumer sentiment weakening, the economic outlook remains uncertain. Higher prices and job market concerns could weigh on consumer spending in the coming months, potentially slowing economic growth. Investors and businesses will be closely watching for signals from the Fed as it navigates a delicate balancing act between inflation control and economic
Michael Kupinski, Director of Research, Equity Research Analyst, Digital, Media & Technology , Noble Capital Markets, Inc.
Jacob Mutchler, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Q4 in line with previously revised guidance. Q4 and full year 2024 revenue of $9.1 million and $62.3 million, respectively, were in line with the company’s revised guidance but were below our expectations of $14.5 million and $67.7 million, respectively. Consequently, an adj. EBITDA loss of $3.4 million was below our estimate of a loss of $2.3 million. We believe that investors will likely focus on the revenue outlook, which appears encouraging.
A sanguine revenue outlook. Management highlighted recent client “wins”, which are expected to be reflected starting in Q2. We believe that this gave management confidence to provide full year 2025 revenue guidance of $90 million to $110 million. The high margin Buy Side segment is expected to be a key area of focus to grow revenue and achieve improved cash flow.
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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.
Joe Gomes, CFA, Managing Director, Equity Research Analyst, Generalist , Noble Capital Markets, Inc.
Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
4Q Results. Revenue of $788 million rose 1.7% y-o-y, exceeded our expectation of $775 million, and was at the high end of guidance. Impacted by the revenue mix, gross margin of 31.9% was below our 33.3% projection. Adjusted EBITDA came in at $40.4 million, below our $52.5 million projection. Net income, aided by $21.8 million of favorable tax items, totaled $27.6 million, or $0.23/sh. Adjusted EPS was $0.26, up from $0.23 last year.
Promising Order Growth. Organic order growth in the fourth quarter was 9%, driven by a 12% increase in Americas orders and 1% International order growth. This was the sixth consecutive quarter of year-over-year order growth in the Americas, reflecting continued gains in market share, in our view. Order growth was seen across most customer segments, with especially strong growth from large corporate and government customers.
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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.
GeoVax Labs, Inc. is a clinical-stage biotechnology company developing novel therapies and vaccines for solid tumor cancers and many of the world’s most threatening infectious diseases. The company’s lead program in oncology is a novel oncolytic solid tumor gene-directed therapy, Gedeptin®, presently in a multicenter Phase 1/2 clinical trial for advanced head and neck cancers. GeoVax’s lead infectious disease candidate is GEO-CM04S1, a next-generation COVID-19 vaccine targeting high-risk immunocompromised patient populations. Currently in three Phase 2 clinical trials, GEO-CM04S1 is being evaluated as a primary vaccine for immunocompromised patients such as those suffering from hematologic cancers and other patient populations for whom the current authorized COVID-19 vaccines are insufficient, and as a booster vaccine in patients with chronic lymphocytic leukemia (CLL). In addition, GEO-CM04S1 is in a Phase 2 clinical trial evaluating the vaccine as a more robust, durable COVID-19 booster among healthy patients who previously received the mRNA vaccines. GeoVax has a leadership team who have driven significant value creation across multiple life science companies over the past several decades.
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.
4Q24 Meets Expectations As Pipeline Advances. GeoVax reported 4Q24 loss of $8.3 million or $(0.88) per share and a loss of $25.0 million or $(4.82) per share for FY2024. The company updated its three clinical programs with CM04S1, the Gedeptin Phase 2, and the MVA program, which continue to make progress as expected. On December 31, 2024, cash on hand was $5.5 million, excluding the proceeds of a $4.5 million offering completed in March 2025.
Clinical Supplies Were Made for the CM04S1 Phase 2b BARDA Trial. Geovax has manufactured clinical supplies for the Phase 2b trial, testing CM04S1 as a booster for healthy adults who have received an mRNA vaccine against COVID-19. This trial is sponsored by a BARDA grant, with estimated revenues of $25 to $45 million for the company, plus about $350 million allocated for direct clinical trial expenses. The trial is now expected to begin late in 2025 to early 2026.
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Mark Reichman, Managing Director, Equity Research Analyst, Natural Resources, Noble Capital Markets, Inc.
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Investor webinar. Century Lithium recently discussed the Angel Island Lithium project during an insightful investor webinar. Key highlights included: 1) Angel Island is an advanced project with one of the largest lithium deposits in the United States, 2) the project employs a proven patent-pending process for chloride leaching, along with direct lithium extraction to produce lithium carbonate, 3) Century has a secured a 1,770 acre-feet per year water rights permit, and 4) the company has demonstrated its ability to consistently produce battery grade lithium carbonate on-site at its pilot plant in Amargosa Valley, Nevada.
Updated feasibility study. Century Lithium recently completed an initial internal optimization study of the project and identified potential cost reductions of up to 25%, or $395.2 million, associated with the project’s Phase I capital expenditures totaling $1,580.7 billion. We think additional cost-reduction measures could apply to the second and third production phases of the project. Century expects to complete an updated feasibility study as early as by year-end.
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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.
Key Points: – U.S.-based production shields Tesla from Trump’s auto tariffs, unlike GM and Ford. – Musk says ending tax credits would hurt rivals more than Tesla. – Musk sees self-driving tech as Tesla’s key long-term value.
President Donald Trump’s latest move to impose 25% tariffs on foreign automobiles and certain auto parts has shaken the auto industry, sending shares of major automakers tumbling. General Motors (GM) stock fell nearly 7%, while Ford (F) dropped 3%. But Tesla (TSLA) went in the opposite direction, climbing 5% in early trading, as analysts suggested the EV leader may be a “relative winner” in the tariff battle.
Unlike many of its competitors, Tesla is largely insulated from the impact of Trump’s tariffs thanks to its U.S.-based production. While the company operates gigafactories in China and Germany, none of the EVs built at those sites are sold in the U.S. Instead, Tesla’s American customers receive vehicles manufactured in Fremont, California, or Austin, Texas. This domestic production model allows Tesla to avoid the direct cost increases that automakers relying on foreign imports will now face.
By comparison, 77% of Ford’s vehicles are made in the U.S., followed by Stellantis (57%), Nissan (52%), and GM (52%). Many of these companies now find themselves in a difficult position, forced to absorb higher costs or pass them on to consumers. According to TD Cowen analyst Itay Michaeli, Tesla stands to benefit as its competitors struggle with price hikes. In particular, Tesla’s Model Y, a leading seller in the midsize crossover category, faces competition in a segment where nearly half of vehicles could now be subject to tariffs.
Despite Tesla’s apparent advantage, CEO Elon Musk has downplayed the impact of the tariffs on the company. In a post on X, Musk stated that Tesla is “NOT unscathed here” and that the impact on the company remains “significant.” However, he did not elaborate on how or why Tesla might be affected. While the new policy appears to hit Tesla’s competitors far harder, Musk’s comments suggest the company is still navigating challenges related to supply chains and international trade.
Trump, for his part, confirmed that he did not consult Musk before finalizing the tariffs, suggesting that the billionaire CEO “may have a conflict.” While Trump did not clarify the statement, it raises questions about whether Tesla’s relatively strong position under the new policy influenced the decision to exclude Musk from discussions.
Beyond tariffs, another potential battleground is the federal EV tax credit. Under the Inflation Reduction Act signed by President Biden in 2022, buyers can receive up to $7,500 in tax credits for purchasing an electric vehicle. Tesla has benefited from these incentives for years, particularly in its early days when it relied on federal subsidies to boost demand. However, Musk has previously indicated that Tesla no longer depends on these credits. He even suggested that if Trump and a Republican-controlled Congress were to eliminate them, it would hurt Tesla’s competitors far more than Tesla itself.
“I think it would be devastating for our competitors and for Tesla slightly. But long term, probably actually helps Tesla, would be my guess,” Musk said during Tesla’s Q2 earnings call last year.
The bigger bet for Tesla, however, isn’t just EVs—it’s autonomy. Musk has repeatedly stated that self-driving technology is Tesla’s true long-term value driver, not car sales. If Trump’s administration eases regulations around self-driving and robotaxi deployment, Tesla could benefit significantly.
For now, investors seem to agree with Musk. While traditional automakers scramble to reassess their supply chains and pricing strategies, Tesla’s stock continues to rise, reinforcing its position as one of the few beneficiaries of Trump’s aggressive trade policies.
Key Points: – Oil prices remain vulnerable to the global trade war, impacting Gulf economies dependent on crude exports. – Currency pegs to the U.S. dollar pose challenges, particularly for countries with high external debt. – New trade corridors, particularly between the Gulf and Asia, offer potential opportunities amid shifting global supply chains.
The Middle East has largely avoided direct tariffs in the ongoing global trade war, but its economies remain vulnerable to broader economic shifts. With oil demand at risk, currency pressures mounting, and global trade flows changing, the region must navigate an increasingly uncertain landscape while also seizing new opportunities.
One of the most immediate concerns for the Middle East is oil. While a weaker U.S. dollar initially benefits oil-exporting nations by making crude cheaper for foreign buyers, tariffs and economic slowdowns could lead to lower global demand. Brent crude prices remain sensitive to global trade conditions, and a prolonged trade war could weigh on revenues for major producers like Saudi Arabia and the UAE. Despite efforts to diversify their economies, oil remains the backbone of many Gulf nations, making them particularly exposed to shifts in global demand.
Another challenge comes from currency pegs. Several Gulf states, including Saudi Arabia, the UAE, Qatar, Oman, and Bahrain, have their currencies tied to the U.S. dollar. As the dollar fluctuates in response to tariffs and economic policies, these countries face higher import costs. This could lead to inflationary pressures, especially in economies heavily reliant on imported goods. At the same time, countries with significant external debt, such as Lebanon, Jordan, and Egypt, could struggle with higher debt-servicing costs if the dollar strengthens further.
Trade tensions also pose risks to regional trade hubs like the UAE, which depend on global trade flows. As a logistics and financial center, Dubai has built its economy around international commerce, meaning a prolonged global slowdown could impact its growth. Economists warn that while Gulf economies have taken steps to diversify, the effects of reduced trade volumes could still be felt.
However, the situation is not entirely negative. The trade war has also encouraged the creation of new trade corridors, particularly between the Gulf and Asia. The GCC-Asia trade relationship has seen sustained growth, with increasing investment and business ties. China’s Belt and Road Initiative has already deepened economic connections, and as global supply chains shift, Middle Eastern economies could benefit from a larger role in these emerging trade networks.
Political factors could also play a role in shaping the region’s economic resilience. U.S. President Donald Trump has maintained strong ties with Gulf nations, particularly Saudi Arabia, and has shown an interest in keeping them aligned with U.S. economic and geopolitical priorities. This relationship may provide some buffer against trade war fallout, as evidenced by Jordan’s ability to secure exemptions from certain U.S. tariffs due to its strategic importance.
Looking ahead, Middle Eastern economies must continue to adapt to changing global conditions. Strengthening domestic demand, securing diversified trade partnerships, and managing currency risks will be key strategies for mitigating potential downturns. While challenges remain, opportunities exist for the region to carve out a more influential role in global trade as supply chains and economic alliances shift.
Breakthroughs breathe new life into legacy systems as agencies look for platforms to safely run AI models with sensitive data, ISG Provider Lens™ report says
STAMFORD, Conn.–(BUSINESS WIRE)– State and local governments in the U.S. are reevaluating mainframes as strategic assets and revisiting choices between reengineering and cloud migration, according to a new research report published today by Information Services Group (ISG) (Nasdaq: III ), a global AI-centered technology research and advisory firm.
The 2025 ISG Provider Lens™ Mainframe — Services and Solutions report for the U.S. public sector finds that AI is beginning to make mainframes easier and less expensive to maintain. Agencies are also discovering that mainframes may be uniquely suited to running AI workloads while protecting mission-critical data. Advances in AI created a wave of public-sector interest in mainframes in 2024 that is expected to continue into 2025.
“AI offers a wealth of new options to help the public sector unleash the potential of mainframe systems,” said Nathan Frey, ISG partner and lead, U.S. Public Sector. “When agencies weigh those possibilities against the risks of moving data and applications that have run on mainframes for decades, they often reconsider their roadmaps.”
State, local and educational (SLED) agencies in the U.S. are now considering which applications to keep on mainframes, how to optimize those applications and how to efficiently access mainframe data for use with AI models, the report says. AI, including generative AI, can streamline software development, testing and documentation, making it easier to either refactor or maintain mainframe applications. AI code assistants and chatbots can reduce the impact of the mainframe skills shortage by helping newer developers get up to speed.
More agencies are exploring the potential of AI and gaining a new appreciation for mainframes’ formidable processing and data management capabilities. The Trump administration’s avowed goal of reducing the size and influence of the federal government is expected to increase interest in using AI for automation. State and local governments are considering the same as they face tight budgets and the possibility of taking over some federal functions.
Policies on offshoring state and local government data and computing are also changing, the report says. New hybrid cloud architectures make it easier to use resources outside the U.S. for cost savings while complying with regulations. DevOps methodologies offer new ways to segregate highly sensitive information, which needs to remain on premises or in the U.S., from less sensitive data that can safely be stored offshore.
Rising U.S. public-sector demand for mainframe services has attracted more providers to this market. However, as agencies increase their reliance on providers, they are gravitating toward those that have built up experience in the sector and that understand its unique mainframe requirements.
“State and local agencies in the U.S. are finally rising to the challenge of modernizing age-old mainframe IT environments,” said Jan Erik Aase, partner and global leader, ISG Provider Lens Research. “Leading service providers have the AI tools and specialized skills to help them make the leap.”
The report also explores other mainframe trends in the U.S. public sector, including rising IT collaboration among SLED agencies around the country and the impact of new training initiatives by providers.
For more insights into the mainframe challenges faced by the U.S. public sector, including software licensing issues and national political uncertainty, plus ISG’s advice for addressing them, see the ISG Provider Lens™ Focal Points briefing here.
The 2025 ISG Provider Lens™ Mainframe — Services and Solutions report for the U.S. public sector evaluates the capabilities of 29 providers across four quadrants: Mainframe Optimization Services, Application Modernization Services, Mainframe as a Service and Mainframe Operations.
The report names Wipro as a Leader in all four quadrants. It names DXC Technology, Ensono, Kyndryl and TCS as Leaders in three quadrants each. Accenture, FNTS and Infosys are named as Leaders in two quadrants each. Avanade, Capgemini, HCLTech, NTT DATA and Tech Mahindra are named as Leaders in one quadrant each.
In addition, DXC Technology is named as a Rising Star — a company with a “promising portfolio” and “high future potential” by ISG’s definition — in one quadrant.
In the area of customer experience, UST is named the global ISG CX Star Performer for 2024 among mainframe service providers. UST earned the highest customer satisfaction scores in ISG’s Voice of the Customer survey, part of the ISG Star of Excellence™ program, the premier quality recognition for the technology and business services industry.
Customized versions of the report are available from FNTS and RecoveryPoint.
The 2025 ISG Provider Lens™ Mainframe — Services and Solutions report for the U.S. public sector is available to subscribers or for one-time purchase on this webpage.
About ISG Provider Lens™ Research
The ISG Provider Lens™ Quadrant research series is the only service provider evaluation of its kind to combine empirical, data-driven research and market analysis with the real-world experience and observations of ISG’s global advisory team. Enterprises will find a wealth of detailed data and market analysis to help guide their selection of appropriate sourcing partners, while ISG advisors use the reports to validate their own market knowledge and make recommendations to ISG’s enterprise clients. The research currently covers providers offering their services globally, across Europe, as well as in the U.S., Canada, Mexico, Brazil, the U.K., France, Benelux, Germany, Switzerland, the Nordics, Australia and Singapore/Malaysia, with additional markets to be added in the future. For more information about ISG Provider Lens research, please visit this webpage.
About ISG
ISG (Nasdaq: III ) is a global AI-centered technology research and advisory firm. A trusted partner to more than 900 clients, including 75 of the world’s top 100 enterprises, ISG is a long-time leader in technology and business services that is now at the forefront of leveraging AI to help organizations achieve operational excellence and faster growth. The firm, founded in 2006, is known for its proprietary market data, in-depth knowledge of provider ecosystems, and the expertise of its 1,600 professionals worldwide working together to help clients maximize the value of their technology investments.
Source: Information Services Group, Inc.View all news
CHATHAM, N.J., March 27, 2025 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a biopharmaceutical company with marketed products and a pipeline of development candidates, today announced that Seth Lederman, M.D., Chief Executive Officer, will present a poster at the AAPM 2025 Annual Meeting, PainConnect, in Austin, Texas on April 5, 2025, at 11:45 a.m. CT. The meeting will take place from April 3-6, 2025.
Tonix is a fully-integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also 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 CNS portfolio includes TNX-1300 (cocaine esterase), a biologic in Phase 2 development designed to treat cocaine intoxication that has FDA Breakthrough Therapy designation, and its development is supported by a grant from the National Institute on Drug Abuse. 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 also has product candidates in development in infectious disease, including a vaccine for mpox, TNX-801. Tonix recently announced a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years to develop TNX-4200, small molecule broad-spectrum antiviral agents 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 Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults.
* 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.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners.
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.
Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine.
Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age.
Important Safety Information
Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack:
discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back
severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
pain or discomfort in your arms, back, neck, jaw or stomach
shortness of breath with or without chest discomfort
breaking out in a cold sweat
nausea or vomiting
feeling lightheaded
Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem.
Do not use Zembrace or Tosymra if you have:
history of heart problems
narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease)
uncontrolled high blood pressure
hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider.
had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation
severe liver problems
taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure.
are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure.
an allergy to sumatriptan or any of the components of Zembrace or Tosymra
Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements.
Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert.
Zembrace and Tosymra may cause serious side effects including:
changes in color or sensation in your fingers and toes
sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever
cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet
increased blood pressure including a sudden severe increase even if you have no history of high blood pressure
medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider.
serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking.
hives (itchy bumps); swelling of your tongue, mouth, or throat
seizures even in people who have never had seizures before
The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only).
Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider.
This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633.
You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) — Gyre Therapeutics (“Gyre”) (Nasdaq: GYRE), an innovative, commercial-stage biotechnology company with clinical development programs focusing on organ fibrosis, today announced the publication of the manuscript titled “Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Hepatitis B: Protocol for a Phase 3 Randomized Trial” in the Journal of Clinical and Translational Hepatology. This publication details the full protocol for the pivotal Phase 3 trial to support the use of hydronidone in Chinese patients with liver fibrosis associated with chronic hepatitis B (“CHB”). The published protocol outlines patient inclusion criteria, randomization and blinding processes, key assessments, and the statistical analysis plan.
The randomized, double-blind, placebo-controlled, multicenter Phase 3 trial (NCT05115942) completed the enrollment of 248 patients across 44 clinical research hospitals in the People’s Republic of China (“PRC”) in October 2024. Patients were randomized 1:1 to receive either F351 or placebo in addition to entecavir antiviral basic therapy for CHB. The primary endpoint is a decrease in liver fibrosis (as measured by the Ishak Scoring System) by at least one stage after 52 weeks of treatment relative to baseline.
The PRC’s National Medical Products Administration (“NMPA”) designated F351 as a “Breakthrough Therapy” in 2021. Gyre expects to report topline results from this Phase 3 trial in the second quarter of 2025.
About Hydronidone (F351)
F351 is a next-generation anti-fibrotic compound and a structural analogue of Pirfenidone, the first approved treatment for idiopathic pulmonary fibrosis (“IPF”) in Japan, the European Union, the United States and the PRC. F351’s dual mechanism has been shown to inhibit in vitro p38γ kinase activity and TGF-β1-driven collagen overproduction—both key drivers of liver fibrosis. F351 specifically targets hepatic stellate cells (“HSCs”), which are central to the progression of fibrosis. In preclinical studies, it has shown strong anti-proliferative and anti-fibrotic effects on HSCs. These effects have been validated across multiple in vivo models of liver fibrosis, including CCl4-induced liver fibrosis in mice, DMN- and HSA-induced liver fibrosis in rats, and a mouse model of MASH fibrosis (a form of MASH with fibrosis) induced by CCl4 plus a Western high-fat diet. Together, these results highlight F351’s potential as a differentiated treatment for liver fibrosis, with a unique mechanism and strong preclinical and clinical evidence supporting its advancement into later-stage development.
About Gyre Pharmaceuticals
Gyre Pharmaceuticals is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (Pirfenidone capsule), was the first approved treatment for IPF in the PRC in 2011 and has maintained a prominent market share (2024 net sales of $105.8 million). In addition, Gyre Pharmaceuticals is evaluating F351 in a Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC, which is expected to readout topline data by Q2 2025. F351 received Breakthrough Therapy designation by the NMPA Center for Drug Evaluation in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, DKD, COPD, PAH and ALF/ACLF. In October 2023, Gyre Therapeutics acquired an indirect majority interest in Gyre Pharmaceuticals (also known as Beijing Continent Pharmaceuticals Co., Ltd.).
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, with a primary focus on the development and commercialization of F351 (Hydronidone) for the treatment of MASH-associated fibrosis in the U.S. Gyre’s development strategy for F351 in MASH is based on the company’s experience in MASH rodent model mechanistic studies and CHB-induced liver fibrosis clinical studies. Gyre is also advancing a diverse pipeline in the PRC through its indirect controlling interest in Gyre Pharmaceuticals, including ETUARY therapeutic expansions, F573, F528, and F230.
Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, which statements are subject to substantial risks and uncertainties and are based on estimates and assumptions. All statements, other than statements of historical facts included in this press release, are forward-looking statements, including statements concerning: the expectations regarding Gyre’s research and development efforts and timing of expected clinical readouts, including timing of topline data from Gyre Pharmaceuticals’ Phase 3 clinical trial evaluating F351 for the treatment of CHB-associated liver fibrosis in the PRC. In some cases, you can identify forward-looking statements by terms such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “plan” or the negative of these terms, and similar expressions intended to identify forward-looking statements. These statements reflect our plans, estimates, and expectations, as of the date of this press release. These statements involve known and unknown risks, uncertainties and other factors that could cause our actual results to differ materially from the forward-looking statements expressed or implied in this press release. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: Gyre’s ability to execute on its clinical development strategies; positive results from a clinical trial may not necessarily be predictive of the results of future or ongoing clinical trials; the timing or likelihood of regulatory filings and approvals; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of Gyre’s capital resources and its ability to raise additional capital. Additional risks and factors are identified under “Risk Factors” in Gyre’s Annual Report on Form 10-K for the year ended December 31, 2024 filed on March 17, 2025 and in other filings the Company may make with the Securities and Exchange Commission.
Gyre expressly disclaims any obligation to update any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.
