Category: 3. Business

  • Energy, Infrastructure, and Connectivity – Publications

    Energy, Infrastructure, and Connectivity – Publications


    Insight




    December 05, 2025

    As 2025 draws to a close, tech companies have continued to pour an unprecedented amount of capital into data centers, unveiling multi-billion-dollar investments to meet the surging demand for compute capacity. The United States is expected to continue to lead the way in new infrastructure development and deployment, though Western Europe and Asia are emerging as regions poised for significant growth in investment and build out.

    By 2030, analysts are projecting that there will be over 2,000 new data centers constructed worldwide. Global data center infrastructure spending is projected to approach $7 trillion over the next five years, with the bulk of that capital flowing into servers and the chips that drive modern data center performance.  

    Evolving Financing Models

    While the financial figures continue to rise, considerations for investors across capital markets become increasingly complicated. Location, build-out timelines, and load capacity requirements are key factors shaping project risk. Given the significant capital expenditure involved, investors have had to adopt strategies that not only address the upfront spending required but also account for long-term economic and debt considerations.

    To meet the scale of today’s buildouts, investors are increasingly relying on layered capital strategies that combine long-term financing with mechanisms that provide early cash flow. These include tenant prepayment structures, joint ventures with infrastructure funds and pension investors, and real estate–focused arrangements, such as sale-leaseback transactions.

    At the same time, traditional project finance lenders are playing a growing role in the sector, underwriting large, syndicated loans supported by long-term leases, stable power-supply arrangements, and other risk-mitigation measures that can anchor billion-dollar developments.

    Energy and Power Considerations

    Despite the growing clarity around investment pathways, power reliability remains crucial with regard to the future of large-scale data center build-out efforts. With respect to data center power needs, two principal considerations emerge: ensuring reliable power generation and determining the vehicles by which that power is procured. Many hyperscalers have adopted ambitious clean energy goals and are prioritizing low-carbon alternatives like nuclear and renewables paired with energy storage systems.

    Ensuring resilient transmission from those power sources to the data center can present significant challenges, particularly given the regulatory hurdles involved. Co-location has emerged as an option for data center developers, siting the facilities alongside existing power generation sources, along with Bring Your Own Generation (BYOG). Still, these arrangements also raise regulatory concerns, as the Federal Energy Regulatory Commission and state energy agencies have often scrutinized these efforts due to resource adequacy and reliability concerns.

    Against this backdrop, nuclear power is quickly emerging as a central focus for data center operators seeking reliable, long-term, carbon-free power. Many hyperscalers are already forming partnerships with nuclear companies, exploring options that range from funding the development of new nuclear technology to the restart of previously retired plants.

    Growing interest in new-build nuclear, both large-scale facilities and smaller, modular reactor designs, is positioning advanced nuclear generation as an increasingly viable component of future data center power strategies.

    Server Connectivity

    While reliable grid connectivity remains a necessity for any data center, so too is the high-capacity fiber connectivity that enables data centers to function at scale. Redundant, high-capacity fiber infrastructure is crucial to maintain a dependable connection between data centers themselves and with users and customers all over the world. Diversity in transmission connectivity can also boost overall reliability, with some data centers pairing multiple fiber lines with wireless or satellite point-to-point connections.

    One of the primary ways global fiber networks are deployed is through submarine cables, which currently carry more than 98% of all international internet traffic and data. Hyperscalers have become the largest developers of these long-haul systems, leveraging direct ownership stakes and dedicated capacity arrangements to efficiently move data across their global facilities.

    In contrast to the heavily regulated energy side, ownership and operation of data centers remain largely unregulated from a telecommunications perspective, at least in the United States. While licenses to operate data centers aren’t currently required by the Federal Communications Commission or most state telecom regulators, the network services provided by hyperscalers are often subject to various regulatory obligations. To secure connectivity, data center operators typically work with telecommunications carriers through established arrangements such as Indefeasible Rights of Use, capacity leases, and master services agreements that provide long-term access to fiber infrastructure.

    As data center development accelerates, industry stakeholders will need to continue to navigate rising investment demands, evolving power strategies, and growing connectivity needs. Those able to balance these pressures with thoughtful planning and diversified infrastructure approaches will be best positioned to meet the next wave of global demand.

    We invite you to subscribe to receive updates on our Data Center Bytes and join us during our Data Center Bytes webinar series.

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  • Apple and Google Push Back Against India’s Proposed Mandatory Location Tracking – TipRanks

    1. Apple and Google Push Back Against India’s Proposed Mandatory Location Tracking  TipRanks
    2. India’s government plans to enforce mandatory satellite-based monitoring, opposed jointly by three major smartphone manufacturers including Apple.  富途牛牛
    3. Is the Modi Govt Working on a Proposal to Insist All Cellphones Have Location ‘on’ at All Times?  TheWire.in
    4. India Proposes Mandatory Always-On Smartphone Tracking, Drawing Tech Giant Protests  WebProNews
    5. Apple, Google, Samsung ask India to not accept telecom proposal over privacy concerns and warn of regulatory overreach-sources, document  marketscreener.com

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  • Valuation After an Earnings Beat and Full-Year Guidance Cut

    Valuation After an Earnings Beat and Full-Year Guidance Cut

    Bruker (BRKR) just reported a classic mixed earnings result, topping quarterly profit estimates while simultaneously trimming its full year revenue and earnings outlook. This combination has clearly cooled investor enthusiasm.

    See our latest analysis for Bruker.

    The guidance cut comes after a sharp rebound in sentiment, with Bruker’s 30 day share price return of 19.8 percent and 90 day gain of 56.9 percent, in contrast with a weaker 1 year total shareholder return of negative 17.0 percent. This suggests that near term momentum is improving even as the longer term record remains underwhelming.

    If this kind of volatility has you thinking about diversification, it may be worth exploring healthcare stocks as a way to uncover other healthcare names with different growth and risk profiles.

    With earnings beating expectations but guidance moving lower, and the share price now hovering just below analyst targets after a strong rebound, is Bruker an underappreciated turnaround candidate, or is the market already pricing in any future recovery?

    Compared with Bruker’s last close near 48 dollars, the most popular narrative pins fair value slightly higher, implying only marginal upside from here.

    The analysts have a consensus price target of $46.727 for Bruker based on their expectations of its future earnings growth, profit margins and other risk factors. However, there is a degree of disagreement amongst analysts, with the most bullish reporting a price target of $65.0, and the most bearish reporting a price target of just $38.0.

    Read the complete narrative.

    Want to see what kind of revenue path, margin rebuild, and future earnings multiple are stitched together to justify this tight valuation gap? The answer might surprise you.

    Result: Fair Value of $48.83 (ABOUT RIGHT)

    Have a read of the narrative in full and understand what’s behind the forecasts.

    However, persistent funding headwinds and execution risk around margin improvement could easily derail the constructive bookings story and reset expectations again.

    Find out about the key risks to this Bruker narrative.

    While the narrative fair value sits close to the market price, our DCF model paints a cooler picture, putting Bruker’s value nearer 36.72 dollars. This suggests the shares look overvalued at current levels. Is the market now leaning too heavily on the recovery story?

    Look into how the SWS DCF model arrives at its fair value.

    BRKR Discounted Cash Flow as at Dec 2025

    Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out Bruker for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 910 undervalued stocks based on their cash flows. If you save a screener we even alert you when new companies match – so you never miss a potential opportunity.

    If you see the story differently or want to dig into the numbers yourself, you can build a custom view in just minutes using Do it your way.

    A great starting point for your Bruker research is our analysis highlighting 2 key rewards and 1 important warning sign that could impact your investment decision.

    Before you move on, lock in a few fresh opportunities that match your style so you are not relying on just one turnaround story.

    This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

    Companies discussed in this article include BRKR.

    Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team@simplywallst.com

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  • Bilal Bin Saqib says Pakistan to launch its ‘own stablecoin’

    Bilal Bin Saqib says Pakistan to launch its ‘own stablecoin’

    Pakistan Virtual Assets Regulatory Authority Chairman Bilal Bin Saqib speaks at a panel discussion in Dubai, United Arab Emirates, December 5, 2025. — X/@cryptocouncilpk 
    • Stablecoin could be used to collateralise government debt: Bilal.
    • Pakistan seeks to be at forefront of digital innovation: crypto czar.
    • “Why should we be at tail end when we have muscle and adoption?”

    Pakistan is set to launch its own stablecoin as part of efforts to embrace digital financial innovation, Bilal Bin Saqib, Chairman of the Pakistan Virtual Assets Regulatory Authority (PVARA), announced on Thursday.

    According to CoinDesk, a digital media outlet focusing on cryptocurrency, blockchain, and the digital asset economy, a stablecoin is a type of cryptocurrency whose value is pegged to another asset class, such as a fiat currency or gold, to stabilise its price.

    Speaking at Binance Blockchain Week in Dubai, he said that the country is experimenting with both a stablecoin and a Central Bank Digital Currency (CBDC), but stressed that the stablecoin initiative will definitely move forward.

    The crypto czar highlighted that the stablecoin could serve as a tool to collateralise government debt, adding that Pakistan aims to be at the forefront of global digital financial developments.

    “Why should we be at the tail end of it when we have the muscle and the adoption?” he remarked, underlining the country’s ambition to lead rather than follow in this emerging financial sector.

    Separately, the Pakistan Crypto Council said that Saqib spoke on a high-level panel discussing the future of virtual assets and emerging-market regulation.

    “He emphasised that for countries like Pakistan, clear and innovation-friendly crypto regulation is a key driver of economic growth. Pakistan’s work on stablecoins, data frameworks, and banking the unbanked can become valuable case studies for the world,” the council wrote on X.

    Pakistan’s crypto market is estimated to have more than 40 million users with an annual trading volume exceeding $300 billion, making it among the most active frontier markets for digital assets.

    Earlier in May, Bilal unveiled the country’s first government-led Strategic Bitcoin Reserve, marking a historic pivot in the nation’s digital and financial outlook.

    Addressing a global audience that included US Vice President JD Vance, Eric Trump, and Donald Trump Jr in Las Vegas, he positioned Pakistan as a forward-looking digital hub, powered by its tech-savvy youth and strengthened by a shift toward decentralised finance.

    Bilal revealed that the reserve would not be used for speculation or trading but would serve as a sovereign holding — signalling long-term commitment to blockchain-based finance. The national Bitcoin wallet already holds assets under state custody.


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  • FDA Publishes New Draft Guidance on Reducing Animal Testing in Nonclinical Safety Studies – Holland & Knight

    1. FDA Publishes New Draft Guidance on Reducing Animal Testing in Nonclinical Safety Studies  Holland & Knight
    2. How science can phase out animal testing  Financial Times
    3. Simulations Plus (SLP) Poised to Benefit from New FDA Guidance  GuruFocus
    4. The CDC Is Ending Testing on Monkeys. Here’s What We Know.  A-Z Animals
    5. Guidance on primate testing is ‘genuine’ animal welfare progress  BioWorld MedTech

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  • Science journal retracts study on safety of Monsanto’s Roundup: ‘serious ethical concerns’ | US news

    Science journal retracts study on safety of Monsanto’s Roundup: ‘serious ethical concerns’ | US news

    The journal Regulatory Toxicology and Pharmacology has formally retracted a sweeping scientific paper published in 2000 that became a key defense for Monsanto’s claim that Roundup herbicide and its active ingredient glyphosate don’t cause cancer.

    Martin van den Berg, the journal’s editor in chief, said in a note accompanying the retraction that he had taken the step because of “serious ethical concerns regarding the independence and accountability of the authors of this article and the academic integrity of the carcinogenicity studies presented”.

    The paper, titled Safety Evaluation and Risk Assessment of the Herbicide Roundup and Its Active Ingredient, Glyphosate, for Humans, concluded that Monsanto’s glyphosate-based weed killers posed no health risks to humans – no cancer risks, no reproductive risks, no adverse effects on development of endocrine systems in people or animals.

    Regulators around the world have cited the paper as evidence of the safety of glyphosate herbicides, including the Environmental Protection Agency (EPA) in this assessment.

    The listed authors of the paper were three scientists who did not work for Monsanto – Gary Williams, Robert Kroes and Ian Munro, and was held up by the company as a defense against conflicting scientific evidence linking Roundup to cancer. The fact that it was authored by scientists from outside the company, from seemingly independent researchers, gave it added validity.

    But over the last decade, internal company documents, that came to light in litigation brought by plaintiffs in the US suffering from cancer, revealed Monsanto’s influence on the paper. The documents included an email from a company official discussing the research paper and praising the “hard work” of several Monsanto scientists as part of a strategy Monsanto called “Freedom to Operate” (FTO).

    The corporate files showed how company officials celebrated when the paper was published.

    In one email following the April 2000 publication of the Williams paper, Lisa Drake, then Monsanto government affairs official, described the toll the work of developing “independent” research papers took on multiple Monsanto employees.

    “The publication by independent experts of the most exhaustive and detailed scientific assessment ever written on glyphosate … was due to the perseverance, hard work and dedication of the following group of folks,” Drake wrote. She then listed seven Monsanto employees. The group was applauded for “their hard work over three years of data collection, writing, review and relationship building with the papers’ authors”.

    Drake further emphasized why the Williams paper was so significant for Monsanto’s business plans: “This human health publication on Roundup herbicide and its companion publication on ecotox and environmental fate will be undoubtedly be [sic] regarded as ‘the’ reference on Roundup and glyphosate safety,” she wrote in the email dated 25 May 2000.

    “Our plan is now to utilize it both in the defense of Roundup and Roundup Ready crops worldwide and in our ability to competitively differentiate ourselves from generics.”

    In a separate email, a company executive asked if Roundup logo polo shirts could be given to eight people who worked on the research papers as a “token of appreciation for a job well done”.

    Monsanto’s Hugh Grant, who at that time was a senior executive on his way toward being named CEO and chairman, added his own praise, writing in an email: “This is very good work, well done to the team, please keep me in the loop as you build the PR info to go with it.”

    In 2015, William Heydens, a Monsanto scientist, suggested that he and colleagues “ghost-write” another scientific paper. Monsanto could pay outside scientists to “edit & sign their names” to the work that he and others would do, Heydens wrote in an email. “Recall that is how we handled Williams Kroes and Munro 2000.”

    The emails were spotlighted in jury trials in which plaintiffs suffering from cancer won billions of dollars in damages from Monsanto, which was bought by Bayer AG in 2018.

    Gary Williams, one of the authors of the now retracted 2000 research paper, could not immediately be reached for comment. In 2017, Williams’s former employer New York Medical School said it found “no evidence” that a faculty member violated the school’s prohibition against authoring a paper ghostwritten by employees of Monsanto. The two other authors of the paper, Robert Kroes and Ian Munro, are deceased.

    In explaining the decision to retract the 25-year-old research paper, Van den Berg wrote: “Concerns were raised regarding the authorship of this paper, validity of the research findings in the context of misrepresentation of the contributions by the authors and the study sponsor and potential conflicts of interest of the authors.”

    He noted that the paper’s conclusions regarding the carcinogenicity of glyphosate were solely based on unpublished studies from Monsanto, ignoring other outside, published research.

    Van den Berg did not respond to a request for comment.

    When asked about the retraction, Bayer said in a statement that Monsanto’s involvement was adequately noted in the acknowledgments section of the paper in question, including a statement that referred to “key personnel at Monsanto who provided scientific support”. The company said the vast majority of thousands of published studies on glyphosate had no Monsanto involvement.

    “The consensus among regulatory bodies worldwide that have conducted their own independent assessments based on the weight of evidence is that glyphosate can be used safely as directed and is not carcinogenic,” the company said.

    An EPA spokesperson said that the agency was aware of the retraction but “has never relied on this specific article in developing any of its regulatory conclusions on glyphosate”.

    The spokesperson said the EPA has “extensively studied glyphosate, reviewing more than 6,000 studies across all disciplines, including human and environmental health, in developing its regulatory conclusions”.

    The updated human health risk assessment the agency is currently conducting for glyphosate is “using gold standard science”, the spokesman said. That assessment should be released for public comment in 2026 and will not rely on the retracted article.

    “The retraction of this study is a long time coming,” said Brent Wisner, one of the lead lawyers in the Roundup litigation and a key player in getting the internal documents revealed to the public.

    Wisner said the Williams, Kroes and Munro study was the “quintessential example of how companies like Monsanto could fundamentally undermine the peer-review process through ghostwriting, cherrypicking unpublished studies, and biased interpretations”.

    “This garbage ghostwritten study finally got the fate it deserved,” Wisner said. “Hopefully, journals will now be more vigilant in protecting the impartiality of science on which so many people depend.”

    News of the retraction of the study came in the same week the Trump administration urged the US supreme court to take up Bayer’s bid to curtail thousands of lawsuits claiming Roundup causes cancer.

    In a brief filed at the court, the solicitor general, D John Sauer, said the company was correct that the federal law governing pesticides pre-empts lawsuits that make failure-to-warn claims over the products under state law.

    Plaintiffs have said they developed non-Hodgkin’s lymphoma and other forms of cancer due to using Roundup and other glyphosate-based herbicides sold by the company, either at home or on the job.

    This story is co-published with the New Lede, a journalism project of the Environmental Working Group.

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  • AI credit concerns playing out differently in investment grade and high yield, Goldman says – Reuters

    1. AI credit concerns playing out differently in investment grade and high yield, Goldman says  Reuters
    2. Wall Street races to protect itself from AI bubble  Rolling Out
    3. Barclays exec says top five tech firms could need $100 billion in funding next year  WKZO
    4. The AI Industry’s Tangled Finances  The Dispatch
    5. Taking a position: AI debt frenzy gives birth to new CDS markets  IFR Asia

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  • FDA Okays CAR T-Cell Therapy for Marginal Zone Lymphoma – Medscape

    1. FDA Okays CAR T-Cell Therapy for Marginal Zone Lymphoma  Medscape
    2. Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)  Bristol Myers Squibb
    3. Bristol Myers Squibb wins fifth US approval for CAR T cell therapy Breyanzi  European Pharmaceutical Review
    4. FDA Approves Liso-Cel in Pretreated R/R Marginal Zone Lymphoma  Oncology Nursing News
    5. FDA Approves CAR-T Therapy for Marginal Zone Lymphoma  Oncology News Central

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  • Sobi to Showcase Scientific advances and Commitment to Haematology at ASH 2025

    Sobi to Showcase Scientific advances and Commitment to Haematology at ASH 2025

    Sobi® (STO: SOBI), today announced its participation at the 65th American Society of Hematology (ASH) Annual Meeting, taking place on 6 – 9 December in Orlando, Florida. At this year’s meeting, Sobi will showcase its commitment to advancing care in haematology with 19 scientific abstracts, including two oral presentations. These feature the most recent clinical data and insights from completed and ongoing studies across Sobi’s innovative portfolio including data from efanesoctocog alfa, pegcetacoplan, avatrombopag, emapalumab, and pacritinib. These presentations underscore Sobi’s mission to deliver life-changing therapies for patients with rare and severe blood disorders.

     

    “We will present evidence at ASH from a post hoc analysis demonstrating that pacritinib reduces or stabilises spleen size, improves haematologic parameters, and lessens myelofibrosis symptoms in patients with highrisk disease. These findings matter because they address key drivers of morbidity which affect daytoday functioning and quality of life. The ASH meeting also offers an opportunity to discuss the latest research on emapalumab, efanesoctocog alfa, pegcetacoplan, avatrombopag, as well as loncastuximab tesirine,” said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi.

     

     

    Summary of full Sobi data to be presented at ASH 2025:

    Efanesoctocog alfa

    Clinical outcomes up to four years of once-weekly Efanesoctocog Alfa Prophylaxis in previously treated adults, adolescents, and children with severe Haemophilia A: Interim analysis of the Phase 3 XTEND-ed long-term extension study.

     

     

     

     

    Oral Presentation

    Session Name: 322. Haemophilia A and B: Clinical and epidemiological: Innovations shaping the future of Haemophilia care

    Date: 7 December 2025

    Time: 12:00 PM – 1:30 PM ET

    Presentation Time: 1:00 PM – 1:15 PM ET

    Room: OCCC – W304EFGH

    Publication Number: 539

    Understanding unmet needs for people with Haemophilia A receiving factor and non-factor treatments.

     

     

     

    Poster Presentation

    Session Name: Poster Session I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 2679

    Real-world experience of Efanesoctocog Alfa in Haemophilia A patients in the US: A retrospective analysis.

    Poster Presentation

    Session Name: Poster Session I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 1286

    Patient characteristics, treatment patterns, and bleeding in people with Haemophilia A without inhibitors initiating Efanesoctocog alfa in the US: An administrative claims analysis.

    Poster Presentation

    Session Name: Poster Session I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 1290

    Quality of life and functional improvements with Efanesoctocog alfa in patients with moderate to severe Haemophilia A: A real-world survey.

    Poster Presentation

    Session name: Poster Session III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Publication Number: 4846

    Pegcetacoplan

    Consistent benefits of Pegcetacoplan treatment in PNH patients with and without a history of Aplastic Anaemia in real world: Analysis of the ongoing COMPLETE Phase 4 observational study.

     

     

    Poster Presentation

    Session Name: 101. Red Cells and Erythropoiesis, Excluding Iron: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Early results from the ongoing Pegcetacoplan Silo of the International Paroxysmal Nocturnal Haemoglobinuria Interest Group Registry.

    Poster Presentation

    Session Name: 508. Bone Marrow Failure: Acquired: Poster II

    Date: 7 December 2025

    Time: 6:00:00 PM – 6:00:00 PM ET

    Location: OCCC – West Halls B3-B4

    Real-world clinical characteristics and treatment outcomes in PNH patients prescribed Pegcetacoplan: Insights of complement inhibitor-experienced and -naïve patients across Europe, the United States and Canada.

     

     

    Poster Presentation

    Session Name: 508. Bone Marrow Failure: Acquired: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Pegcetacoplan – Publication Only Abstracts

    Real-world effectiveness of Pegcetacoplan in Paroxysmal Nocturnal Haemoglobinuria: A systematic review of clinical and patient-reported outcomes.

     

    Publication only – published online on 3 November 2025, at 9:00 AM ET

    Low risk for Meningococcal and encapsulated bacteria infections with systemically administered Pegcetacoplan in Paroxysmal Nocturnal Haemoglobinuria and C3 Glomerulopathies.

     

    Overview of treatment advances with complement Inhibitors in patients with Paroxysmal Nocturnal Haemoglobinuria.

     

    Optimising PNH treatment with the complement inhibitor Pegcetacoplan: A case report.

    User experience with Pegcetacoplan on-body Injector in patients with Paroxysmal Nocturnal Hemoglobinuria.

    Avatrombopag

    Real-world treatment patterns and outcomes among patients with immune thrombocytopenia (ITP) who switched treatment from Eltrombopag or Romiplostim to Avatrombopag in the United States: Results from the real-AVA 3.5 study.

     

    Poster Presentation

    Session Name: 905. Outcomes research: Non-malignant conditions excluding Hemoglobinopathies: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Real-world safety and efficacy of Avatrombopag in adults with Immune Thrombocytopenia: A systematic review and meta-analysis.

    Global Abstract

    Session Name: 311. Disorders of platelet number or function: Clinical and epidemiological: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Patient-reported outcomes of Avatrombopag for Chronic Immune Thrombocytopenia: Interim analysis of the Phase 4 ADOPT Study.

     

     

     

     

    Poster Presentation

    Session Name: 905. Outcomes research: Non-malignant conditions excluding Hemoglobinopathies: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Emapalumab

    Use of Emapalumab is associated with rapid and sustained benefits in pHLH subgroups, including CNS involvement and previously untreated patients: Pooled analysis of prospective trials NI-0501-04, NI-050105 and NI-050109.

     

    Poster Presentation

    Session Name: 201. Granulocytes, Monocytes, and Macrophages: Poster II

    Date: 7 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Emapalumab induces rapid, durable responses and reliable bridging to curative HSCT in patients with primary HLH: Pooled analysis of prospective trials NI-0501-04, NI-0501-05 and NI-0501-09.

     

     

    Poster Presentation

    Session Name: 201. Granulocytes, Monocytes, and Macrophages: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Pacritinib

    Real-world treatment patterns and outcomes in patients with myelofibrosis who presented with thrombocytopenia and anaemia at initiation of Pacritinib treatment.

     

     

     

     

    Oral Presentation

    Session Name: 908. Outcomes Research: Myeloid

    Malignancies: Real-World Experiences

    Session date: 7 December 2025

    Session time: 4:30 PM – 6:00 PM ET

    Presentation time: 5:30 PM – 5:45 PM

    Room: OCCC – W414CD

    Pacritinib in patients with high-risk myelofibrosis: Outcomes from post-hoc analyses of two Phase 3 studies.

     

     

     

     

    Poster Presentation

    Session Name: 634. Myeloproliferative Syndromes: Clinical and epidemiological: Poster I

    Date: 6 December 2025

    Time: 5:30 PM – 7:30 PM ET

    Room: OCCC – West Halls B3-B4

    Real-world treatment patterns and clinical outcomes in patients with Myelofibrosis treated with Pacritinib (PAC): Results from the MY-PAC Study.

     

     

    Poster Presentation

    Session Name: 908. Outcomes research: Myeloid Malignancies: Poster II

    Date: 7 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    PROSPERA (ABNL-MARRO 002): A randomised Phase 2 study of Pacritinib vs. Hydroxyurea in patients with Advanced Proliferative Chronic Myelomonocytic Leukaemia (CMML)

     

     

     

    Poster Presentation

    Session Name: 637. Myelodysplastic Syndromes: Clinical and epidemiological: Poster II

    Date: 7 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Treatment patterns and outcomes in patients with myelofibrosis treated with Pacritinib following a switch from Ruxolitinib: The MY-PAC Study.

     

     

    Session Name: 634. Myeloproliferative Syndromes: Clinical and epidemiological: Poster III

    Date: 8 December 2025

    Time: 6:00 PM – 8:00 PM ET

    Room: OCCC – West Halls B3-B4

    Incidence, prevalence, and clinical outcomes of Myelofibrosis with and without Cytopenia in the United States.

     

     

     

     

    About ALTUVOCT ® (efanesoctocog alfa)

    ALTUVOCT® (efanesoctocog alfa) is indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (HA). ALTUVOCT can be used for all age groups and any disease severity.

     

    About the Sobi and Sanofi Collaboration
    Sobi and Sanofi collaborate on the development and commercialisation of ALTUVOCT® (efanesoctocog alfa), or ALTUVIIIO™ in the US. Sobi has final development and commercialisation rights in the Sobi territory (essentially Europe, North Africa, Russia, and most Middle Eastern markets). Sanofi has final development and commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

     

    About Aspaveli®/Empaveli® (pegcetacoplan)
    Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b inhibitor designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Aspaveli/Empaveli is approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the US, European Union, and other countries globally, and for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in the United States. It is under regulatory review for C3G and primary IC-MPGN in the European Union and other countries globally.

     

    About the Sobi and Apellis Collaboration

    Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan, and its opt-in rights for future development programs are unchanged, exercisable at any time prior to commercialisation. Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

     

    About Doptelet® (avatrombopag)

    Doptelet (avatrombopag) is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments, and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) scheduled to undergo an invasive procedure. Doptelet is also approved for the treatment of chronic ITP in pediatric patients.

     

    About Gamifant® (emapalumab-lzsg)
    Gamifant is an anti-IFNγ antibody that binds free and receptor-bound IFNγ, which when secreted in an uncontrolled manner can cause hyperinflammation. Gamifant is indicated for intravenous infusion over one hour and is FDA approved for the treatment of primary hemophagocytic lymphohistiocytosis (HLH) and macrophage activation syndrome (MAS) in Still’s disease.

     

    About Vonjo® (pacritinib)
    Vonjo (pacritinib) is a kinase inhibitor indicated in the United States for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10⁹/L. This indication is approved under accelerated approval based on spleen volume reduction. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. Vonjo is also being investigated for other rare hematologic conditions, including VEXAS syndrome.

     

    Sobi®

    Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

     

     

    Contacts

    For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

     

     

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  • Apple, Google send new round of cyber threat notifications to users around world – Reuters

    1. Apple, Google send new round of cyber threat notifications to users around world  Reuters
    2. Apple Warns Users in 84 Countries of New Cyber Threat Activity  TradingView
    3. Apple Issues Huge State-Backed Hacking Warning to Global Users  TipRanks
    4. Apple sent new round of cyber threat notifications to users in 84 countries By Reuters  Investing.com
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