Category: 3. Business

The Swedish-based drinks manufacturer Oatly has been banned from using the word “milk” to market its plant-based products, after a ruling by the UK supreme court.

The alt-milk manufacturer has been in a long-running legal battle with the trade association Dairy UK after Oatly trademarked phrases associated with the dairy sector.

On Wednesday the supreme court unanimously ruled that Oatly can no longer trademark, or use, the slogan “Post Milk Generation”.

“It has taken the highest court in the land to decide once and for all whether a plant-based milk alternative can be branded as ‘milk’ and marketed as such,” said Laurie Bray, a senior associate and trademark attorney at the European intellectual property company Withers & Rogers. “And the outcome is not what Oatly was hoping for.”

Regulations state that certain terms can only be used to denote the actual products they describe, such as milk, wine and olive oil. Milk is defined as coming from the dairy sector and, more specifically, animals.

However, Oatly, which first filed a trademark application for the term “Post Milk Generation” with the UK’s Intellectual Property Office in 2019 – which was registered officially in 2021 – had argued that the use of the term ”milk” in a trademark did not breach regulations if it was not being used in a descriptive manner.

In 2023, after an objection from Dairy UK, the IPO ruled that the use of the word “milk” in this way was “deceptive”; Oatly successfully appealed against the ruling in December 2023, but that decision was then overturned by the court of appeal, prompting it to take the issue to the supreme court.

The supreme court ruling has wider ramifications for producers of plant-based alternatives, and Oatly’s trademark registrations in other European countries could now be challenged by equivalent trade bodies to Dairy UK.

The same regulations apply to terms that are derived from other milk-based products such as cream, butter, cheese and yoghurt.

“For plant-based producers the safer course is to use clearly descriptive alternatives such as ‘oat drink’, or ‘plant-based drink’,” said Richard May, a partner at Osborne Clarke. “More broadly, the judgment signals that UK regulators and courts are likely to take a robust approach to so-called ‘category borrowing’ across regulated sectors. Businesses building brands around legally defined product names, whether in dairy or elsewhere, should expect careful scrutiny and plan their brand strategy accordingly.”

In 2021, Glebe Farm Foods, a Cambridgeshire-based company that specialises in producing gluten-free oats, won a trademark infringement battle brought by Oatly over its use of the brand name PureOaty.

Fourth Quarter 2025

• Net sales of $2,880 million, 23% higher than fourth quarter 2024
• Operating profit up 27% and adjusted operating profit⁽¹⁾ up 33% from fourth quarter 2024. Adjusted operating margin of 23.2%, up 170 basis points compared to fourth quarter 2024
• Operating cash flow of $1,005 million and adjusted free cash flow⁽¹⁾ of $910 million, an increase of 136% and 151%, respectively, compared to prior year fourth quarter. Net leverage of ~0.5x at the end of fourth quarter

Full Year 2025

• Organic sales growth of 26% compared to prior year. Full year diluted EPS growth of 166% and adjusted diluted EPS growth of 47%. Full year operating cash flow of $2,114 million and adjusted free cash flow of $1,887 million, an increase of 60% and 66%, respectively, compared to prior year

Full Year 2026

• Expect net sales of $13,250 to $13,750 million, with organic sales growth of 27% to 29% compared to 2025
• Expect full year 2026 diluted EPS of $5.27 to $5.37 and adjusted diluted EPS of $5.97 to $6.07, an increase of 56% and 43%, respectively, at the midpoint compared to full year 2025

COLUMBUS, Ohio, Feb. 11, 2026 /PRNewswire/ — Vertiv Holdings Co (NYSE: VRT), a global leader in critical digital infrastructure, today reported financial results for its fourth quarter and full year ended December 31, 2025. Vertiv reported fourth quarter net sales of $2,880 million, an increase of $534 million, or 23%, compared to fourth quarter 2024, driven by organic sales growth of 19%. Orders momentum accelerated significantly with fourth quarter organic orders up approximately 252% compared to last year’s fourth quarter and up 117% sequentially from third quarter 2025. While the Americas region and hyperscale/colocation data centers were the primary drivers of order strength, order growth was broad-based across regions, technologies and customers. The company’s trailing twelve-month organic orders grew approximately 81% compared to the prior year period, reflecting robust market demand, particularly in AI infrastructure. Fourth quarter 2025 book-to-bill ratio was ~2.9x and backlog increased to $15.0 billion, up 109% compared to the same period last year.

Fourth quarter operating profit of $580 million increased $123 million and adjusted operating profit of $668 million increased $164 million, up 27% and 33%, respectively, from fourth quarter 2024. Adjusted operating margin was 23.2%, up 170 basis points compared to fourth quarter 2024, driven by operational leverage on higher volume, productivity and favorable price-cost, partially offset by tariff impact.

“Our fourth quarter performance demonstrates Vertiv’s leadership position in an increasingly complex and demanding data center market,” said Giordano Albertazzi, Vertiv’s Chief Executive Officer. “Significant growth in orders, sales, margins and cash reflects our ability to scale while maintaining a sharp focus on operational execution. What differentiates Vertiv is our ability to anticipate and shape the industry direction. Deep collaborations with semiconductor industry leaders, combined with our decades-long industry expertise and technology-rich portfolio, enable us to optimize customer outcomes by anticipating needs before they become apparent. We architect systems that deliver superior outcomes today and position our customers well to meet tomorrow’s challenges. As we look to 2026, we expect this momentum to continue. Our record backlog provides clear visibility into what we expect to be another year of significant growth.”

“Today’s results reflect years of strategic focus on technology leadership and value creation,” said Dave Cote, Vertiv’s Executive Chairman. “Our commitment to developing technology that transforms the industry has positioned us as the partner customers turn to for solving their most complex challenges. This technology leadership isn’t just about winning today, it’s about driving sustainable, long-term growth by continuously redefining what’s possible for our customers and the industry.”

Adjusted Free Cash Flow and Liquidity

Net cash generated by operating activities in the fourth quarter was $1,005 million and adjusted free cash flow was $910 million, an increase of $580 million and $548 million, respectively, from fourth quarter 2024. Fourth quarter adjusted free cash flow performance was driven by higher adjusted operating profit, working capital efficiency, including project-related advanced payments and lower cash interest, partially offset by higher cash taxes and increased capital expenditures to support growth.

The company’s strong cash generation enabled Vertiv to deploy approximately $1 billion for strategic growth acquisitions during the quarter while maintaining low leverage and a strong balance sheet. Liquidity remained strong at $2.6 billion and net leverage was approximately 0.5x at the end of fourth quarter, reflecting continued strong operational performance and cash generation. Vertiv continues its commitment to obtaining and maintaining investment grade credit ratings.

Updated Full Year and First Quarter 2026 Guidance

The data center market continues to show robust momentum, with strong pipeline growth despite significant pipeline conversion to orders in the fourth quarter. To capitalize on these opportunities, Vertiv is strategically increasing ER&D investments and expanding production capacity.

Fourth Quarter 2025 Earnings Conference Call

Vertiv’s management team will discuss the Company’s results during a conference call on Wednesday, February 11, starting at 11 a.m. Eastern Time. The call will contain forward-looking statements and other material information regarding Vertiv’s financial and operating results. A webcast of the live conference call will be available for interested parties to listen to by going to the Investor Relations section of the Company’s website at investors.vertiv.com. A slide presentation will be available before the call and will be posted to the website, also at investors.vertiv.com. A replay of the conference call will also be available for 30 days following the webcast.

About Vertiv Holdings Co

Vertiv (NYSE: VRT) brings together hardware, software, analytics and ongoing services to enable its customers’ vital applications to run continuously, perform optimally and grow with their business needs. Vertiv solves the most important challenges facing today’s data centers, communication networks and commercial and industrial facilities with a portfolio of power, cooling and IT infrastructure solutions and services that extends from the cloud to the edge of the network. Headquartered in Westerville, Ohio, USA, Vertiv does business in more than 130 countries. For more information, and for the latest news and content from Vertiv, visit vertiv.com.

Category: Financial News

Non-GAAP Financial Measures

Financial information included in this release has been prepared in accordance with Generally Accepted Accounting Principles (“GAAP”). Vertiv has included certain non-GAAP financial measures in this news release, as indicated above, that may not be directly comparable to other similarly titled measures used by other companies and therefore may not be comparable among companies. These non-GAAP financial measures include organic net sales growth (including on a segment basis), adjusted operating profit, adjusted operating margin, adjusted diluted EPS and adjusted free cash flow, which management believes provides investors with useful supplemental information to evaluate the Company’s ongoing operations and to compare with past and future periods. Management also uses certain non-GAAP measures internally for forecasting, budgeting and measuring its operating performance. These measures should be viewed as supplementing, and not as an alternative or substitute for, the Company’s financial results prepared in accordance with GAAP. Pursuant to the requirements of Regulation G, Vertiv has provided reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures.

Information reconciling certain forward-looking GAAP measures to non-GAAP measures related to first quarter and full-year 2026 guidance, including organic net sales growth, adjusted free cash flow and adjusted operating margin, is not available without unreasonable effort due to high variability, complexity and uncertainty with respect to forecasting and quantifying certain amounts that are necessary for such reconciliations. For those reasons, we are unable to compute the probable significance of the unavailable information, which could have a potentially unpredictable, and potentially significant, impact on our future GAAP financial results.

See “Reconciliation of GAAP and Non-GAAP Financial Measures” in this release for Vertiv’s reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures.

Cautionary Note Concerning Forward-Looking Statements

This news release, and other statements that Vertiv may make in connection therewith, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 with respect to Vertiv’s future financial or business performance, strategies or expectations, and as such are not historical facts. This includes, without limitation, statements regarding Vertiv’s financial position, capital structure, indebtedness, business strategy and plans and objectives of Vertiv management for future operations, as well as statements regarding growth, anticipated demand for our products and services and our business prospects during 2026, as well as expected impacts from our pricing actions, and our guidance for first quarter and full year 2026 and statements regarding tariffs, global trade conflict and any actions we may take in response thereto. These statements constitute projections, forecasts and forward-looking statements, and are not guarantees of performance. Vertiv cautions that forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this news release, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “strive,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this release are based on current expectations and beliefs concerning future developments and their potential effects on Vertiv. There can be no assurance that future developments affecting Vertiv will be those that Vertiv has anticipated. Vertiv undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Vertiv’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Vertiv has previously disclosed risk factors in its Securities and Exchange Commission (“SEC”) reports, including those set forth in the Vertiv 2024 Annual Report on Form 10-K filed with the SEC on February 18, 2025. These risk factors and those identified elsewhere in this release, among others, could cause actual results to differ materially from historical performance and include, but are not limited to: risks relating to the continued growth of our customers’ markets; long sales cycles for certain Vertiv products and solutions as well as unpredictable placing or cancelling of customer orders; failure to realize sales expected from our backlog of orders and contracts; disruption of or consolidation in our customer’s markets or categorical shifts in customer technology spending; less leverage with large customer contract terms; failure to mitigate risks associated with long-term fixed price contracts; competition in the industry in which we operate; failure to obtain performance and other guarantees from financial institutions; risks associated with governmental contracts; failure to properly manage production cost changes and supply; failure to anticipate market change and competition in the infrastructure technologies; risks associated with information technology disruption or cyber-security incidents; risks associated with the implementation and enhancement of information systems; failure to realize the expected benefit from any rationalization, restructuring and improvement efforts; disruption of, or changes in, Vertiv’s independent sales representatives, distributors and original equipment manufacturers; increase of variability in our effective tax rate costs or liabilities associated with product liability due to global operations subjecting us to income and other taxes in the U.S. and numerous foreign entities; costs or liabilities associated with product liability and damage to our reputation and brands; the global scope of Vertiv’s operations, especially in emerging markets; failure to benefit from future significant corporate transactions; risks associated with Vertiv’s sales and operations and expanding global production facilities; risks associated with future legislation and regulation of Vertiv’s customers’ markets; our ability to comply with various laws and regulations including but not limited to, laws and regulations relating to data protection and data privacy; failure to properly address legal compliance issues, particularly those related to imports/exports, anti-corruption laws, and foreign operations; risks associated with foreign trade policy, including tariffs and global trade conflict risks associated with litigation or claims against the Company, including the risk of adverse outcomes to any legal claims and proceedings; our ability to protect or enforce our proprietary rights on which our business depends; third party intellectual property infringement claims; liabilities associated with environmental, health and safety matters; failure to achieve environmental, social and governance goals; failure to realize the value of goodwill and intangible assets; exposure to fluctuations in foreign currency exchange rates; failure to remediate material weaknesses in our internal controls over financial reporting; our level of indebtedness and our ability to comply with the covenants and restrictions contained in our credit agreements; our ability to access funding through capital markets; resales of Vertiv securities may cause volatility in the market price of our securities; our organizational documents contain provisions that may discourage unsolicited takeover proposals; our certificate of incorporation includes a forum selection clause, which could discourage or limit stockholders’ ability to make a claim against it; the ability of our subsidiaries to pay dividends; factors relating to the business, operations and financial performance of Vertiv and its subsidiaries, including: global economic weakness and uncertainty; our ability to attract, train and retain key members of our leadership team and other qualified personnel; the adequacy of our insurance coverage; fluctuations in interest rates materially affecting our financial results and increasing the risk our counterparties default in our interest rate hedges; our incurrence of significant costs and devotion of substantial management time as a result of operating as a public company; and other risks and uncertainties indicated in Vertiv’s SEC reports or documents filed or to be filed with the SEC by Vertiv. Forward-looking statements included in this news release speak only as of the date of this news release or any earlier date specified for such statements. All subsequent written or oral forward-looking statements attributable to Vertiv or persons acting on Vertiv’s behalf may be qualified in their entirety by this Cautionary Note Concerning Forward-Looking Statements.

For investor inquiries, please contact:
Lynne Maxeiner
Vice President, Global Treasury & Investor Relations
Vertiv
E: [email protected]

For media inquiries, please contact:
Ruder Finn for Vertiv
E: [email protected]

 

Reconciliation of GAAP and non-GAAP Financial Measures

To supplement this news release, we have included certain non-GAAP financial measures in the format of performance metrics. Management believes these non-GAAP financial measures provide investors with additional meaningful financial information that should be considered when assessing our underlying business performance and trends. Further, management believes these non-GAAP financial measures also enhance investors’ ability to compare period-to-period financial results. Non-GAAP financial measures should be viewed in addition to, and not as an alternative for, the company’s reported results prepared in accordance with GAAP. Our non-GAAP financial measures do not represent a comprehensive basis of accounting. Therefore, our non-GAAP financial measures may not be comparable to similarly titled measures reported by other companies. Reconciliations of each of these non-GAAP financial measures to GAAP information are also included. Management uses these non-GAAP financial measures in making financial, operating, compensation and planning decisions and in evaluating the company’s performance. Disclosing these non-GAAP financial measures allows investors and management to view our operating results excluding the impact of items that are not reflective of the underlying operating performance.

Vertiv’s non-GAAP financial measures include:

• Adjusted operating profit (loss), which represents operating profit (loss), adjusted to exclude amortization of intangibles, restructuring costs associated with the global restructuring programs, contingent consideration, and merger and acquisition costs;
• Adjusted operating margin, which represents adjusted operating profit (loss) divided by net sales;
• Organic net sales growth, which represents the change in net sales adjusted to exclude the impacts of foreign currency exchange rate and acquisitions;
• Adjusted free cash flow, which represents net cash provided by (used for) operating activities adjusted to exclude capital expenditures and investments in capitalized software; and
• Adjusted diluted EPS, which represents diluted earnings per share adjusted to exclude amortization of intangibles, restructuring costs associated with global restructuring programs, contingent consideration, merger and acquisition costs, net non-recurring tax adjustments, term loan due 2032 amendment expense and change in warranty liability.

Regional Segment Results

Sales by Product and Service Offering

Organic growth by Product and Service Offering

Segment information

Reconciliation of net cash provided by (used for) operating activities to adjusted free cash flow

Reconciliation from operating profit (loss) to adjusted operating profit (loss)

Reconciliation from operating margin to adjusted operating margin

Reconciliation of Diluted EPS to Non-GAAP Adjusted EPS

SOURCE Vertiv Holdings Co

40 firm aircraft with 120 options ordered by Vista and its commonly controlled entities reinforce the Group’s long-term growth strategy and global leadership in private aviation 

DUBAI, UAE, Feb. 11, 2026 /PRNewswire/ — Vista, the world’s leading private aviation group, announced a major fleet agreement with Bombardier, comprising 40 firm orders for the industry leading Challenger 3500 aircraft and 120 additional purchase options. The agreement secures long-term capacity for Vista’s ever growing Member base as global demand for premium private aviation continues to expand.

Deliveries will begin immediately in 2026 and be phased over up to the next 10 years, aligning fleet growth with utilization and regional demand for Vista’s unique global network of silver with a red stripe aircraft. The structure provides Vista with significant flexibility while ensuring readiness to serve Members around the world as travel patterns evolve. It also consolidates Vista’s demand for its Super-Midsize offering on one common platform, which grants clients an identical experience anywhere, anytime. From an operational perspective, this level of scale on one common platform will further drive efficiencies. 

“This agreement is about leadership, preparedness and client experience,” said Thomas Flohr, Founder and Chairman of Vista. “We are continuing to build the fleet our Members will rely on over the next decade, not reacting to short-term cycles, but investing with clarity, scale and discipline.” 

Vista operates the world’s largest global private aviation platform, serving its clients across 96% of the world’s countries through its VistaJet and XO brands. The order comes off the back another year of consecutive double-digit growth on the Group’s multi-year subscription based Program product. In 2025 the Program Member base grew by 12% and Vista flew 16% more live Program hours year-over-year. Program live hours growth was delivered across all markets, with the Group’s core regions of the U.S. and Europe being the largest contributors — up 11% and 15% respectively. Emerging regions continued their impressive trajectory following targeted sales strategies in these areas — the Middle East, Asia and Africa saw Program live hours correspondingly growing 32%, 22% and 30%.

The Challenger 3500 plays a central role in Vista’s fleet strategy, offering exceptional range, reliability and cabin innovation. Vista continues to lead and pioneer the client experience on board — in the past by introducing the pocket door for privacy; then the jump seat for the Cabin Host to ensure every Vista flight is operated with full service; and today, the Challenger 3500 is recognized for featuring the most technologically advanced cabin in its class, with productivity-enhancing features such as the industry’s first voice-controlled cabin, a completely redesigned interior and patented Nuage zero gravity seats.

This agreement follows Vista’s recent completion of its fleet-wide cabin harmonization program and the roll out of next generation highest speed connectivity, positioning the Group for its next phase of growth. 

“Bombardier jets pioneered the super-midsize aircraft category, and with the Challenger 3500 aircraft we continue to raise the bar for customers when it comes to offering a full package of performance, reliability and cabin comfort,” said Éric Martel, President and CEO, Bombardier. “This significant order is a testament to how well this aircraft serves our customers, delivering the perfect balance of cutting-edge technology, exceptional comfort, and proven value. Vista has been a valued Bombardier customer since they began operating. We are proud that our relationship will further deepen through this significant order and are excited for Vista’s teams and clients to benefit from everything the Challenger 3500 aircraft has to offer.” 

With this agreement, Vista reinforces its position as the industry’s most scaled, resilient and future-oriented private aviation group, investing to deliver unmatched availability, consistency and service worldwide.

About Vista

Vista Global Holding Limited (Vista) is the world’s leading global business aviation company providing worldwide business flight services through its network of subsidiaries and a team of over  4,000 experts. A global group headquartered in Dubai, Vista integrates a unique portfolio of companies to offer asset free services to cover all key aspects of business aviation, including guaranteed and on demand global flight coverage, subscription and membership solutions, and trading and management services.

Innovating the industry for over 20 years through continuous investment in talent, technology, and infrastructure, Vista’s mission is to provide the most advanced flying services at the very best value — anytime, anywhere around the world.

Vista’s extensive industry expertise enables it to deliver comprehensive end-to-end solutions and technology to meet the needs of business aviation clients around the world. These services are offered through its leading brands, including VistaJet and XO.

More Vista information and news at www.vistaglobal.com 

Photo – https://mma.prnewswire.com/media/2901971/Bombardier_Challenger_3500_VistaJet.jpg
Logo – https://mma.prnewswire.com/media/2755695/5782088/Vista_Logo.jpg

SOURCE Vista

London, 11^th February, 2026 – Global data and technology company Experian today announces the launch of its Aperture Data Studio integration with Snowflake, the AI Data Cloud company.

The integration enables organisations to leverage Aperture Data Studio’s powerful data quality capabilities to profile, transform, and validate data directly within the Snowflake platform.

By connecting with Snowflake’s AI Data Cloud, Experian has joined Snowflake in mobilising the world’s data to help organisations confidently manage trusted data with a focus on speed, security and simplicity. The combined solution, now available globally, addresses data quality issues without moving data, enabling joint Snowflake and Aperture Data Studio customers to:

●      Keep data secure: Data stays within Snowflake’s secure perimeter, reducing risk and enabling compliance.

●      Accelerate data management: Create workflows in Aperture Data Studio’s intuitive interface and execute them near-instantly in Snowflake.

●      Unify data quality and governance efforts: Empower users to efficiently catalogue, manage and control data while offering accuracy, compliance and confidence at scale.

Andrew Abraham, Global Managing Director, Data Quality, Experian, said: “Data is the foundation of every transformation, yet many businesses struggle to turn it into real business value.

“With the rapid emergence of AI technologies, quality, accurate data is fundamental to its success. Our collaboration with Snowflake brings together Experian’s expertise in data quality and governance with the scale, performance and flexibility of Snowflake’s platform.

“This will allow businesses to not only innovate faster, stay compliant, and reduce risk, but also make trusted data a reality. Today marks the start of our joint efforts to bring Experian’s powerful data quality capabilities to where Snowflake customer data lives.”

Rinesh Patel, Global Head of Financial Services, Snowflake, said: “With the launch of Experian’s integration with the Snowflake AI Data Cloud, we look forward to driving deeper value for our joint customers.

“This integration enables customers to build a trusted, compliant data foundation that reduces risk, accelerates AI adoption and supports smarter decision‑making.”

                                                                                                                               ENDS

Experian Aperture Data Studio combines data quality and governance for data, models and AI agents into one intuitive, scalable platform. The platform ensures your data is always fit for purpose, compliant and ready to power your big ambitions. By partnering with Snowflake, Aperture Data Studio workflows are now available to clients who manage their data on the Snowflake platform.

Snowflake AI Data Cloud Product Partners help customers maximise Snowflake’s flexibility, performance, and ease of use to deliver more meaningful insights. AI Data Cloud Services Partners provide industry experience, technical expertise, and strategic best practices to help customers mitigate risk and drive business value with Snowflake throughout their entire data and AI journey. To learn more about becoming an AI Data Cloud partner, click here. 

Media contact:

Robert Goodman, PR Manager, Corporate & Business, UK&I, Experian

Tel: +44 7989 398 498 / Email: Robert.Goodman@Experian.com

About Experian

Experian is a global data and technology company, powering opportunities for people and businesses around the world. We help to redefine lending practices, uncover and prevent fraud, simplify healthcare, deliver digital marketing solutions, and gain deeper insights into the automotive market, all using our unique combination of data, analytics and software. We also assist millions of people to realise their financial goals and help them to save time and money.

We operate across a range of markets, from financial services to healthcare, automotive, agrifinance, insurance, and many more industry segments.

We invest in talented people and new advanced technologies to unlock the power of data and to innovate. A FTSE 100 Index company listed on the London Stock Exchange (EXPN), we have a team of 25,200 people across 33 countries. Our corporate headquarters are in Dublin, Ireland. Learn more at experianplc.com.

 

 

Powered by Medidata’s AI technologies, complex clinical data is transformed, delivering significantly faster study build and shorter trial timelines

New York – Feb. 11, 2026 – Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, continues to accelerate clinical trial success for biopharmaceutical and medtech customers through enhanced AI-powered capabilities. Its AI technology has been scaled across the Medidata Platform, benefiting over 500 clinical studies in the last decade, including more than 120 AI-supported studies starting in 2025.

Building on its established AI foundation, Medidata continues to seamlessly weave intelligence into more solutions across its unified platform. The latest advancements include significant enhancements to Medidata Designer with the introduction of Medidata AI Study Build. The new capability accelerates study builds by leveraging the study protocol and generative AI to configure Medidata Rave EDC and Medidata eCOA systems, drastically reducing the time required to move from protocol to start-up. This delivers faster study build times, dramatically speeding time-to-market for sponsors and critical decision-making for CROs.

“Leveraging our large clinical data set from more than 38,000 trials, Medidata’s AI is redefining clinical trials, with its impact now evolving from pervasive embedding to quantifiable outcomes,” said Lisa Moneymaker, chief strategy officer, Medidata. “By prioritizing clinically-fluent, regulatory-grade AI to drive results across the trial lifecycle, we are helping our customers turn complexity into clarity and data into decisive action. Our foundational AI engine delivers platform capabilities that allow development teams to focus on resources for advancing patient care.”

To deliver truly intelligent automation, Medidata is accelerating the expansion of Dot, its core AI orchestrator that coordinates and connects the actions of domain specific AI Companions across the platform. The visual presence of Dot enables customers to instantly recognize and access the power of AI built into every step of the clinical trial process. This clear visibility accelerates the use of AI to advance new therapies to patients faster.

“As the life sciences industry increasingly moves toward embedded, enterprise AI solutions, Medidata’s AI Study Build has the potential to transform complex database build processes and accelerate market access, while Dot ensures transparency and builds trust in the use of AI,” said Dr. Nimita Limaye, Research VP, Life Sciences R&D Strategy & Technology, at IDC.

To learn more about Medidata’s AI capabilities, click here.  

In patients with CALR exon 9–mutated myelofibrosis who were resistant or intolerant to prior Janus kinase (JAK) inhibitor therapy or ineligible for such treatment, the first-in-class mutant calreticulin–specific monoclonal antibody INCA033989 as monotherapy or in combination with ruxolitinib appeared to be well tolerated and resulted in spleen and anemia responses and symptom improvements, based on preliminary data from dose escalation of two global phase I studies (INCA033989-101 and INCA033989-102).¹

“Current treatments for myelofibrosis are not mutant-targeted and have limited efficacy in reducing the mutant CALR variant allele frequency,” commented presenting author John O. Mascarenhas, MD, Professor of Medicine, Icahn School of Medicine at Mount Sinai, New York, at the 2025 American Society of Hematology (ASH) Annual Meeting & Exposition. “INCA033989 has a unique mechanism of action…, selectively targeting and binding the mutant CALR protein in complex with the thrombopoietin receptor, thereby internalizing the complex for lysosomal degradation and abrogating oncogenic JAK–STAT signaling…, leading to selective death of CALR-mutant cells and sparing wild-type cells.”

Study Details

Data were from two ongoing phase I, first-in-human, multicenter, open-label studies (INCA033989-101 [outside the U.S.] and -102 [U.S. only]) evaluating INCA033989 in patients with certain classic myeloproliferative neoplasms harboring CALR exon 9 mutations. The presentation focused on those with myelofibrosis; results from the essential thrombocythemia cohort were presented separately during the meeting.²

Eligible patients were aged at least 18 years with primary or post–essential thrombocythemia myelofibrosis, a CALR exon 9 mutation, and splenomegaly of at least 450 mL by imaging or 5 cm by palpation. The monotherapy cohort was either intolerant or resistant to JAK inhibitor therapy after at least 12 weeks, or ineligible for such treatment, while those in the combination therapy cohort had received ruxolitinib for at least 12 weeks with a suboptimal response.

INCA033989 was administered intravenously every 2 weeks, with dose escalation from 24 to 2,500 mg, either as monotherapy or in combination with ruxolitinib. Dose expansion was evaluated in patients receiving monotherapy and combination therapy, as well as in JAK inhibitor–naive patients within these cohorts. The myelofibrosis analysis included 52 and 20 patients in the monotherapy and combination therapy cohorts, respectively.

Dose-limiting toxicities and treatment-emergent adverse events were identified as the primary endpoints. The key secondary endpoints were spleen volume reduction of 25% (SVR25) or 35% (SVR35) or more at weeks 12 and 24; anemia response; symptom improvement (per the MPN Symptom Assessment Form Total Symptom Score [MPN-SAF TSS]); and changes in mutant CALR allele burden.

Monotherapy: Safety

Monotherapy with INCA033989 was “super well tolerated,” as described by Dr. Mascarenhas. Any-grade treatment-emergent adverse events were seen in 96.2% of patients, with treatment-related treatment-emergent adverse events reported in 57.7%. A total of 30.8% of patients experienced a treatment-emergent adverse event of grade 3 or higher. Serious treatment-emergent adverse events occurred in 9.6% of the cohort and included abdominal pain with tendonitis, monoclonal B-cell lymphocytosis (progressed to Mantle cell lymphoma) with small intestinal obstruction, arthritis, basal cell carcinoma, and pyrexia.

Dose reductions (3.8%) and interruptions (5.8%) were “infrequent,” according to Dr. Mascarenhas, and 23.1% of patients had dose delays because of treatment-emergent adverse events. No dose-limiting toxicities were observed, so no maximally tolerated dose was identified. A total of 86.5% of patients remained on treatment, which, in a first-in-human phase I study, is “a testament to its tolerability and safety,” he said.

Increases in aspartate aminotransferase (AST) were reported in 11 patients; nearly half (n = 5 [45%]) had grade 1 elevation at baseline. This treatment-emergent adverse event resolved in nine patients, with the remaining cases being grade 1. One patient required a dose reduction because of grade 3 AST elevation, which resolved, and a subsequent increase was tolerated, “so this was not a major obstacle for treatment with this antibody,” Dr. Mascarenhas explained.

No association between treatment-emergent adverse events and dose was observed.

Monotherapy: Efficacy

Monotherapy with INCA033989 resulted in an SVR25 at week 24 in 41.7% of patients (overall n = 36), while 33.3% achieved SVR35 at the same time point. A total of 47.9% and 31.3% of patients achieved SVR25 and SVR35, respectively, as best SVR. Dr. Mascarenhas added, “In [JAK inhibitor–naive] patients [n = 7]…, the spleen responses were better” compared with those who had previously received such therapy (n = 29) at 24 weeks (SVR25: 71.4% vs 34.5%; SVR35: 57.1% vs 27.6%).

A total of 93.3% of evaluable patients (overall n = 45) experienced symptom improvement, and 60.0% achieved a TSS reduction of at least 50% (TSS50). The TSS50 rate was 39.4% at 24 weeks (overall n = 33); the rates were 60.0% and 35.7% in JAK inhibitor–naive (n = 5) and previously treated (n = 28) patients, respectively.

Improvements in hemoglobin levels were observed in both patients with (defined as hemoglobin < 10 g/dL for men, < 11 g/dL for women) and without anemia “but really impressively in [the former population],” Dr. Mascarenhas stated. Among evaluable patients with anemia (n = 25), 56.0% achieved an anemia response, including major responses in 40.0% and minor responses in 16.0%.

Combination Therapy: Safety 

“Similar in many ways to what we saw with monotherapy,” said Dr. Mascarenhas, INCA033989 was well tolerated in combination with ruxolitinib. Treatment-emergent adverse events occurred in all patients, with 65.0% experiencing treatment-related treatment-emergent adverse events and 55.0% having treatment-emergent adverse events classified as grade 3 or higher. He noted that serious treatment-emergent adverse events were reported in 25.0% of patients and included acute myocardial infarction, anemia, basal cell carcinoma, diffuse large B-cell lymphoma (DLBCL), and stomatitis. Regarding the DLBCL case, he noted, “We see increased risk of second primary malignancies, including lymphomas, in this patient population, so I don’t read much into that.”

Dose reductions and interruptions because of treatment-emergent adverse events occurred in 5.0% of patients each, and 40.0% experienced a dose delay. As with monotherapy, no dose-limiting toxicities were observed, so a maximum tolerated dose was not reached. A total of 85.0% of patients were still receiving treatment, again highlighting its tolerability, Dr. Mascarenhas said.

Four patients experienced elevations in AST and/or alanine aminotransferase (ALT), but all events were grade 1 or 2. Two events remain ongoing.

Combination Therapy: Efficacy

Among evaluable patients at week 24 (n = 12), the SVR25 rate was 50.0% and the SVR35 rate was 25.0%. A best SVR of SVR25 and SVR35 occurred in 11 and 8 patients, respectively.

Symptom improvements were observed in 81.3% of patients (overall n = 16), and 33.3% of those with available percentage change in MPN-SAF TSS from baseline (overall n = 9) achieved TSS50 at week 24.

In evaluable patients (n = 14), 86% had stable anemia during the study. One achieved a major anemia response.

Other Findings

“One of the things that makes this antibody really interesting and very exciting is that it is very selective,” said Dr. Mascarenhas. Exploratory analyses appeared to support the potential of INCA033989 to modify the disease and suggest that “we’re really getting to [its] core.”

Immunohistochemistry demonstrated a reduction in mutated CALR–positive megakaryocytes from screening to the first day of the seventh cycle of treatment. This decrease was found to be accompanied by a corresponding increase in their wild-type counterparts.

Dr. Mascarenhas noted a “very significant” decline in total megakaryocytes in aggregated data from 23 patients, “being driven by a reduction in mutant CALR–positive megakaryocytes.” He added that there was an increase in wild-type CALR megakaryocytes, which “speaks to the normalization of hematopoiesis in the bone marrow.”

Bone marrow fibrosis was found to decrease in 40.0% of patients (overall n = 30). “Very interestingly,” CD71 staining indicated improved erythropoiesis in a population with anemia (n = 14), Dr. Mascarenhas noted, adding that this correlated with anemia responses.

Additionally, among patients who received INCA033989 monotherapy and had at least one postbaseline variant allele frequency measurement (n = 47), 89.4% experienced a reduction, with 10.6% achieving a best reduction of at least 25%.

Clinical Implications

The investigators concluded, “As monotherapy in patients with myelofibrosis intolerant, resistant, or ineligible for JAK inhibitor treatment, and in combination with ruxolitinib, [INCA033989] was well tolerated, with no dose-limiting toxicities and few treatment discontinuations. Promising spleen and anemia responses and symptom improvements occurred in both cohorts despite advanced disease and limited follow-up. Variant allele frequency reductions and single-cell analyses further support the potential disease modifying impact of [INCA033989].”

“These data are clear and robust,” Dr. Mascarenhas stated, “enabling a pivotal registration study in the near future.” The development of a subcutaneous formulation is ongoing, which may “make this easier for the patients,” he added. 

DISCLOSURE: Dr. Mascarenhas has received research funding from Incyte, PharmaEssentia, Geron, Ajax, Novartis, Italfarmaco SpA, Sobi, AbbVie, BMS, Kartos, Disc, and Karyopharm; and has served as a consultant (including giving expert testimony) for Incyte, Novartis, BMS, Geron, Kartos, Karyopharm, AbbVie, Sobi, MorphoSys (now Novartis), Roche, Merck, Keros, Disc, PharmaEssentia, Italfarmaco SpA, Sumitomo, GSK, Galecto, Pfizer, and Blueprint Medicines.

REFERENCES

1. Mascarenhas J, Al-Ali HK, Gupta V, et al: Safety and efficacy of the mutant calreticulin-specific monoclonal antibody INCA033989 as monotherapy or in combination with ruxolitinib in patients with myelofibrosis: Preliminary results from dose escalation of two global phase 1 studies. 2025 ASH Annual Meeting & Exposition. Abstract 484. Presented December 7, 2025.

2. Gupta V, Mascarenhas J, Ali H, et al: Safety and efficacy of INCA033989, a novel first in class mutant calreticulin-specific monoclonal antibody, in patients with essential thrombocythemia. 2025 ASH Annual Meeting & Exposition. Abstract 1024. Presented December 8, 2025.

 

EXPERT POINT OF VIEW

Prithviraj Bose, MD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, commented on the preliminary data on myelofibrosis from the phase I INCA033989-101 and INCA033989-102 studies of the mutant calreticulin–specific monoclonal antibody INCA033989 in an interview with The ASCO Post.

“I can say, without hesitation, the results were very, very positive, and [INCA033989] was extremely well tolerated. I was very impressed with what I saw in myelofibrosis, and we saw even better results in essential thrombocythemia, which you’d expect because it’s a less genomically complex disease,” Dr. Bose said.

Dr. Bose spoke about the need to identify agents that can effectively target mutant CALR: “This is the driver mutation in 25% to 30% of patients with primary myelofibrosis and essential thrombocythemia. Currently, our treatment landscape consists of JAK inhibitors, which are not specific to this driver mutation and do not eradicate the underlying malignant clone. They make patients feel better and even live longer, shrink spleens, and some improve anemia, but they don’t really modify the underlying disease to a major degree. That’s where a drug that selectively targets the driver mutation, such as this one, clearly has appeal.”

In the study, treatment with INCA033989 also resulted in a reduction in mutant CALR variant allele frequency, and this might be a signal of early disease modification, though this remains to be seen, Dr. Bose added. He said that the addition of a disease-modifying agent to the treatment armamentarium would be a true treatment advance. 

DISCLOSURE: Dr. Bose has received research support from Incyte, BMS, CTI (now Sobi), Geron, Janssen, Ionis, Disc, Sumitomo, Karyopharm, Kartos, Telios, MorphoSys (now Novartis), Ajax, Merck, Blueprint Medicines, and Cogent; and has received honoraria/consulting fees from Incyte, BMS, Sobi, GSK, AbbVie, PharmaEssentia, Geron, Ionis, Disc, Sumitomo, Karyopharm, Novartis, Merck, Takeda, Morphic, Jubilant, RayThera, Blueprint Medicines, and Cogent.