Category: 3. Business

  • Ontario Superior Court of Justice awards over CA$5M in damages under the anti-reprisal provisions of the Securities Act

    Ontario Superior Court of Justice awards over CA$5M in damages under the anti-reprisal provisions of the Securities Act


    Leaving Dentons

    Beijing Dacheng Law Offices, LLP (“大成”) is an independent law firm, and not a member or affiliate of Dentons. 大成 is a partnership law firm organized under the laws of the People’s Republic of China, and is Dentons’ Preferred Law Firm in China, with offices in more than 40 locations throughout China. Dentons Group (a Swiss Verein) (“Dentons”) is a separate international law firm with members and affiliates in more than 160 locations around the world, including Hong Kong SAR, China. For more information, please see dacheng.com/legal-notices or dentons.com/legal-notices.

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  • Using generative AI to diversify virtual training grounds for robots | MIT News

    Using generative AI to diversify virtual training grounds for robots | MIT News

    Chatbots like ChatGPT and Claude have experienced a meteoric rise in usage over the past three years because they can help you with a wide range of tasks. Whether you’re writing Shakespearean sonnets, debugging code, or need an answer to an obscure trivia question, artificial intelligence systems seem to have you covered. The source of this versatility? Billions, or even trillions, of textual data points across the internet.

    Those data aren’t enough to teach a robot to be a helpful household or factory assistant, though. To understand how to handle, stack, and place various arrangements of objects across diverse environments, robots need demonstrations. You can think of robot training data as a collection of how-to videos that walk the systems through each motion of a task. Collecting these demonstrations on real robots is time-consuming and not perfectly repeatable, so engineers have created training data by generating simulations with AI (which don’t often reflect real-world physics), or tediously handcrafting each digital environment from scratch.

    Researchers at MIT’s Computer Science and Artificial Intelligence Laboratory (CSAIL) and the Toyota Research Institute may have found a way to create the diverse, realistic training grounds robots need. Their “steerable scene generation” approach creates digital scenes of things like kitchens, living rooms, and restaurants that engineers can use to simulate lots of real-world interactions and scenarios. Trained on over 44 million 3D rooms filled with models of objects such as tables and plates, the tool places existing assets in new scenes, then refines each one into a physically accurate, lifelike environment.

    Steerable scene generation creates these 3D worlds by “steering” a diffusion model — an AI system that generates a visual from random noise — toward a scene you’d find in everyday life. The researchers used this generative system to “in-paint” an environment, filling in particular elements throughout the scene. You can imagine a blank canvas suddenly turning into a kitchen scattered with 3D objects, which are gradually rearranged into a scene that imitates real-world physics. For example, the system ensures that a fork doesn’t pass through a bowl on a table — a common glitch in 3D graphics known as “clipping,” where models overlap or intersect.

    How exactly steerable scene generation guides its creation toward realism, however, depends on the strategy you choose. Its main strategy is “Monte Carlo tree search” (MCTS), where the model creates a series of alternative scenes, filling them out in different ways toward a particular objective (like making a scene more physically realistic, or including as many edible items as possible). It’s used by the AI program AlphaGo to beat human opponents in Go (a game similar to chess), as the system considers potential sequences of moves before choosing the most advantageous one.

    “We are the first to apply MCTS to scene generation by framing the scene generation task as a sequential decision-making process,” says MIT Department of Electrical Engineering and Computer Science (EECS) PhD student Nicholas Pfaff, who is a CSAIL researcher and a lead author on a paper presenting the work. “We keep building on top of partial scenes to produce better or more desired scenes over time. As a result, MCTS creates scenes that are more complex than what the diffusion model was trained on.”

    In one particularly telling experiment, MCTS added the maximum number of objects to a simple restaurant scene. It featured as many as 34 items on a table, including massive stacks of dim sum dishes, after training on scenes with only 17 objects on average.

    Steerable scene generation also allows you to generate diverse training scenarios via reinforcement learning — essentially, teaching a diffusion model to fulfill an objective by trial-and-error. After you train on the initial data, your system undergoes a second training stage, where you outline a reward (basically, a desired outcome with a score indicating how close you are to that goal). The model automatically learns to create scenes with higher scores, often producing scenarios that are quite different from those it was trained on.

    Users can also prompt the system directly by typing in specific visual descriptions (like “a kitchen with four apples and a bowl on the table”). Then, steerable scene generation can bring your requests to life with precision. For example, the tool accurately followed users’ prompts at rates of 98 percent when building scenes of pantry shelves, and 86 percent for messy breakfast tables. Both marks are at least a 10 percent improvement over comparable methods like “MiDiffusion” and “DiffuScene.”

    The system can also complete specific scenes via prompting or light directions (like “come up with a different scene arrangement using the same objects”). You could ask it to place apples on several plates on a kitchen table, for instance, or put board games and books on a shelf. It’s essentially “filling in the blank” by slotting items in empty spaces, but preserving the rest of a scene.

    According to the researchers, the strength of their project lies in its ability to create many scenes that roboticists can actually use. “A key insight from our findings is that it’s OK for the scenes we pre-trained on to not exactly resemble the scenes that we actually want,” says Pfaff. “Using our steering methods, we can move beyond that broad distribution and sample from a ‘better’ one. In other words, generating the diverse, realistic, and task-aligned scenes that we actually want to train our robots in.”

    Such vast scenes became the testing grounds where they could record a virtual robot interacting with different items. The machine carefully placed forks and knives into a cutlery holder, for instance, and rearranged bread onto plates in various 3D settings. Each simulation appeared fluid and realistic, resembling the real-world, adaptable robots steerable scene generation could help train, one day.

    While the system could be an encouraging path forward in generating lots of diverse training data for robots, the researchers say their work is more of a proof of concept. In the future, they’d like to use generative AI to create entirely new objects and scenes, instead of using a fixed library of assets. They also plan to incorporate articulated objects that the robot could open or twist (like cabinets or jars filled with food) to make the scenes even more interactive.

    To make their virtual environments even more realistic, Pfaff and his colleagues may incorporate real-world objects by using a library of objects and scenes pulled from images on the internet and using their previous work on “Scalable Real2Sim.” By expanding how diverse and lifelike AI-constructed robot testing grounds can be, the team hopes to build a community of users that’ll create lots of data, which could then be used as a massive dataset to teach dexterous robots different skills.

    “Today, creating realistic scenes for simulation can be quite a challenging endeavor; procedural generation can readily produce a large number of scenes, but they likely won’t be representative of the environments the robot would encounter in the real world. Manually creating bespoke scenes is both time-consuming and expensive,” says Jeremy Binagia, an applied scientist at Amazon Robotics who wasn’t involved in the paper. “Steerable scene generation offers a better approach: train a generative model on a large collection of pre-existing scenes and adapt it (using a strategy such as reinforcement learning) to specific downstream applications. Compared to previous works that leverage an off-the-shelf vision-language model or focus just on arranging objects in a 2D grid, this approach guarantees physical feasibility and considers full 3D translation and rotation, enabling the generation of much more interesting scenes.”

    “Steerable scene generation with post training and inference-time search provides a novel and efficient framework for automating scene generation at scale,” says Toyota Research Institute roboticist Rick Cory SM ’08, PhD ’10, who also wasn’t involved in the paper. “Moreover, it can generate ‘never-before-seen’ scenes that are deemed important for downstream tasks. In the future, combining this framework with vast internet data could unlock an important milestone towards efficient training of robots for deployment in the real world.”

    Pfaff wrote the paper with senior author Russ Tedrake, the Toyota Professor of Electrical Engineering and Computer Science, Aeronautics and Astronautics, and Mechanical Engineering at MIT; a senior vice president of large behavior models at the Toyota Research Institute; and CSAIL principal investigator. Other authors were Toyota Research Institute robotics researcher Hongkai Dai SM ’12, PhD ’16; team lead and Senior Research Scientist Sergey Zakharov; and Carnegie Mellon University PhD student Shun Iwase. Their work was supported, in part, by Amazon and the Toyota Research Institute. The researchers presented their work at the Conference on Robot Learning (CoRL) in September.

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  • Goldman Sachs Analysts Win $250,000 Charitable Grant at 10th-Annual Analyst Impact Fund

    Goldman Sachs Analysts Win $250,000 Charitable Grant at 10th-Annual Analyst Impact Fund

    Four teams of analysts at the firm awarded $500,000 in charitable grants after pitching Goldman Sachs executives including Chairman and CEO David Solomon

    LONDON, UK, October 8, 2025 – Goldman Sachs today held its 10th-annual Analyst Impact Fund, where the firm’s leadership awarded a team of analysts from the New York and San Francisco offices a $250,000 grant in support of Jacaranda Health. The Analyst Impact Fund is the firm’s global competition where teams of analysts pitch senior leaders, including Chairman and CEO David Solomon, in a bid to win funding for the non-profit of their choice. Over the past decade, more than 6,800 analysts from nearly 70 offices have participated in the competition, directing over $5.5+ million in grants to 168 nonprofits globally.

    The Analyst Impact Fund builds upon Goldman Sachs’ rich history of innovative ideas from extraordinary people and commitment to investing in the next generation of talent and our communities. This year, roughly 1,000 analysts participated in the initiative and over $500,000 in grants were provided to the top 25 teams representing nonprofit organizations from across the globe.

    “Two of Goldman Sachs’ most powerful resources are our capital and our people. The Analyst Impact Fund brings together the best of both and highlights our commitment to excellence, teamwork, innovation and philanthropy,” said David Solomon, Chairman and Chief Executive Officer of Goldman Sachs. “Every year, I look forward to hearing pitches directly from our analysts on how they would use the firm’s capital to make a tangible impact in our communities.”

    The finals brought four teams to the firm’s London office, with representatives based in New York, San Francisco, Dallas, London, Hong Kong, Singapore and Sydney all vying for the $250,000 winning prize. The three runners-up were also awarded a share of $225,000 in grants. Those who attended and tuned in to the event also had a chance to vote for their “Fan Favorite,” awarding an additional $25,000.

    “A decade ago, a powerful vision took hold: to empower Goldman Sachs’ junior talent to lead and deliver meaningful change through our annual Analyst Impact Fund,” said Asahi Pompey, President of Goldman Sachs Gives. “Since then, over 7,000 analysts have gone head-to-head to direct over $5.5 million to nearly 170 nonprofits around the world – pitching their ideas with the same precision, purpose, and passion they deliver to our clients. The Analyst Impact Fund is more than just a competition; it is Goldman Sachs’ culture in action.”

    In addition to David Solomon and Asahi Pompey, the finalists presented to a judging panel of 42 senior Goldman Sachs leaders including:

    • Rishi Sunak, Senior Advisor at Goldman Sachs
    • Anthony Gutman, co-chief executive officer of Goldman Sachs International and global co-head of Investment Banking
    • Kunal Shah, co-chief executive officer of Goldman Sachs International and global co-head of FICC
    • Alison Mass, chairman of Investment Banking and head of the Office of Alumni Engagement
    • Kevin Sneader, president of Asia Pacific Ex-Japan
    • Oonagh Bradley, head of EMEA Compliance and global head of CF&O Compliance and Communications Compliance

    Teams were judged across a number of criteria, including their nonprofit’s leadership, reach and potential for impact, the uniqueness of the proposed project or work of the nonprofit, the team’s analysis of the project goals, and the scalability of the organization’s work, among other considerations. The New York and San Francisco-based team representing Jacaranda Health was identified as the winner by judges. Jacaranda Health is committed to improving maternal and newborn health outcomes by embedding scalable and data driven solutions into public health systems, particularly in resource limited settings across Sub-Saharan Africa. The grant will be used to scale prompts and expand access to new countries.

    All of the finalists focused on charities that were leveraging technology to drive change and impact. The final results were:

    • First place – Team Jacaranda Health won $250,000

      Led by: Julian Daszkal, Ariana Linara, Nia Mosby, Francesca Yao
    • Second place – Team Lifelites won $100,000 and an additional $25,000 for the “Fan Favorite” vote

      Led by: Fared Hassani, Georgina Knapman, Jane Neave, Ayo Odunaiya, Malika Zohidova
    • Third place – Team Conservation X Labs won $75,000

      Led by: Charlie Hao, Elle Sun, Angel Wong, Kai Ting Yeo, Alessandra Dimech
    • Fourth place – Team Let’s Get Ready won $50,000

      Led by: Naysa Alex, David Asham, Valerie Baessa, Natalia Baez, Leslie Jimenez

    About Goldman Sachs

    The Goldman Sachs Group, Inc. is a leading global financial institution that delivers a broad range of financial services to a large and diversified client base that includes corporations, financial institutions, governments and individuals. Founded in 1869, the firm is headquartered in New York and maintains offices in all major financial centers around the world.

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  • Gold surges past $4,000 amid strong safe haven demand

    Gold surges past $4,000 amid strong safe haven demand

    Gold (XAU/USD) marks another milestone on Wednesday, smashing through the $4,000 level for the first time as investors flock to the precious metal amid global economic and political uncertainty, coupled with a dovish Federal Reserve (Fed) outlook.

    At the time of writing, XAU/USD is trading around $4,056, pushing deeper into uncharted territory with prices up more than 4% so far this week.

    The latest leg higher comes despite a stronger US Dollar (USD) as political turmoil in France and Japan fuels safe haven demand, driving flows into both the Greenback and Gold. Meanwhile, the prolonged United States (US) government shutdown has added to market jitters, reinforcing demand for the yellow metal.

    Persistent geopolitical risks, including the ongoing Russia-Ukraine war and tensions in the Middle East, along with concerns about global trade disruptions, have further bolstered Bullion’s safe-haven bid. Meanwhile, steady central bank buying and strong inflows into Gold-backed exchange-traded funds (ETFs) are helping to sustain the metal’s record-breaking rally.

    Market movers: Fed Meeting Minutes take center stage as US shutdown stretches into second week

    • Central banks worldwide are on track to buy 1,000 metric tons of Gold in 2025, marking a fourth consecutive year of hefty purchases as they diversify reserves away from US Dollar-denominated assets into Bullion, according to consultancy Metals Focus.
    • The US government shutdown has entered its second week with no sign of resolution as Democrats refuse to provide the votes needed by the ruling Republican Senate to reopen federal agencies without a deal on extending expiring healthcare subsidies. The prolonged standoff is delaying key economic data, complicating the Fed’s policy outlook, while President Donald Trump’s threat of mass layoffs adds to economic uncertainty.
    • The US Dollar Index (DXY), which tracks the value of the Greenback against a basket of six major currencies, extends gains for a third straight session, climbing to its highest level since August 5, hovering near 98.83 as political shake-ups in France and Japan prompt investors to rotate out of the Euro and Yen.
    • US Treasury yields remain on the back foot across the curve as investors slightly increase bets on faster Fed easing in the months ahead, with 111 basis points (bps) of interest rate cuts priced in by December 2026, according to a Deutsche Bank report. The CME FedWatch Tool indicates markets are pricing a 94.6% chance that the Fed will lower rates by 25 bps at the October 29-30 FOMC meeting.
    • In the absence of key economic releases, traders will focus on comments from Fed officials, with the release of the September Fed Meeting Minutes later on Wednesday, which is expected to provide more context behind the recent “risk-management” rate cut.

    Technical analysis: XAU/USD rally stretches, but overbought signals flag risk of pullback

    Gold’s buying momentum remains unabated with the metal extending its historic run even as signs of overextension emerge. From a technical standpoint, the rally appears stretched, with the monthly Relative Strength Index (RSI) climbing above 90 for the first time since the 1980s, underscoring the risk of near-term overheating.

    On shorter time frames, momentum gauges are similarly elevated, with the 4-hour RSI holding near 76 in overbought territory. This suggests that while the underlying trend remains firmly bullish, the market may face increased odds of a pullback or a period of sideways consolidation as traders book profits and reassess positions.

    Immediate support lies at the 9-period Simple Moving Average (SMA) around the $4,000 mark on the 4-hour chart, followed by the 21-period SMA, which should act as the next downside cushion if prices retreat. On the upside, resistance is anticipated at $4,050, followed by the $4,100 zone, where profit-taking could intensify.

    Gold FAQs

    Gold has played a key role in human’s history as it has been widely used as a store of value and medium of exchange. Currently, apart from its shine and usage for jewelry, the precious metal is widely seen as a safe-haven asset, meaning that it is considered a good investment during turbulent times. Gold is also widely seen as a hedge against inflation and against depreciating currencies as it doesn’t rely on any specific issuer or government.

    Central banks are the biggest Gold holders. In their aim to support their currencies in turbulent times, central banks tend to diversify their reserves and buy Gold to improve the perceived strength of the economy and the currency. High Gold reserves can be a source of trust for a country’s solvency. Central banks added 1,136 tonnes of Gold worth around $70 billion to their reserves in 2022, according to data from the World Gold Council. This is the highest yearly purchase since records began. Central banks from emerging economies such as China, India and Turkey are quickly increasing their Gold reserves.

    Gold has an inverse correlation with the US Dollar and US Treasuries, which are both major reserve and safe-haven assets. When the Dollar depreciates, Gold tends to rise, enabling investors and central banks to diversify their assets in turbulent times. Gold is also inversely correlated with risk assets. A rally in the stock market tends to weaken Gold price, while sell-offs in riskier markets tend to favor the precious metal.

    The price can move due to a wide range of factors. Geopolitical instability or fears of a deep recession can quickly make Gold price escalate due to its safe-haven status. As a yield-less asset, Gold tends to rise with lower interest rates, while higher cost of money usually weighs down on the yellow metal. Still, most moves depend on how the US Dollar (USD) behaves as the asset is priced in dollars (XAU/USD). A strong Dollar tends to keep the price of Gold controlled, whereas a weaker Dollar is likely to push Gold prices up.

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  • China accounts for one-fifth of global drugs in development

    China accounts for one-fifth of global drugs in development

    China-based companies are responsible for 20% of drugs in development globally, reflecting the powerhouse role the country has embraced in the pharmaceutical industry.

    In a recent report by GlobalData, analysis demonstrates how regulatory and policy reforms in China have rapidly advanced its drug development landscape. The country accounts for nearly double the percentage of drugs being developed in the 5EU (France, Germany, Italy, Spain, and the UK), responsible for 11%. The US still leads the way, however, holding a 40% share.

    The Chinese government has been busy over the last decade implementing regulatory initiatives in a bid to increase competitiveness on the global stage. This includes China’s “Opinions on Deepening the Reform of the Review and Approval Processes to Encourage Innovation of Drugs and Medical Devices,” a policy introduced in 2015 designed to accelerate growth in the pharmaceutical and medtech sectors. A further focus on modernising clinical trials has meant the country’s aim of becoming a dominant region for drug pipelines is being realised.

    Gaffar Aga, strategic intelligence analyst at GlobalData, says: “This represents years of regulatory initiatives demonstrated by China, which enabled it to continue to advance into a key source of credible innovation within the global pharmaceutical landscape.”

    The emergence of strong early-stage drug candidates in China has gone hand-in-hand with a steep uptick in licensing deals between the country’s biotechs and Western big pharma companies. One of the biggest transactions this year was AstraZeneca’s $5.2bn deal with CSPC Pharmaceuticals to research chronic disease drug candidates.

    Some of these have followed an increasingly popular deal structure called NewCo. Under this model, instead of a direct agreement between an innovator and a big pharma buyer, rights are assigned to a new company or ‘NewCo’ in which companies and investors hold equity.

    Licensing deals between US and Chinese biopharma companies hit record highs last year, a 280% increase from 2020, according to analysis by GlobalData.

    Across big pharma, transactions rose 66% from $16.6bn in 2023 to $41.5bn in 2024, demonstrating that China is still the go-to place to discover pipeline candidates.

    George El-Helou, strategic intelligence analyst at GlobalData, comments: “China continues to transition from ‘me-too’ to a global innovator, redefining the global drug development landscape. Other markets must continue to monitor China’s pipeline assets to maintain global market share.”

    “China accounts for one-fifth of global drugs in development” was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.

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  • Leonardo staff in Unite union vote to go on strike

    Leonardo staff in Unite union vote to go on strike

    Staff at the defence firm Leonardo who are members of the Unite union have voted “overwhelmingly” in favour of strike action across its main UK sites, in a dispute over pay.

    The Italian-owned company, which has the UK’s only helicopter factory in Yeovil, Somerset, had offered a two-year deal of 3.2%, describing it as fair with the potential through variable pay packages to increase to about 9.2%.

    But Unite says the offer is actually a real-terms pay cut in light of inflation and the on going economic crisis. The union’s regional officer, Carrie Binnie, said: “This strike is entirely the making of Leonardo. It can fix it with the stroke of a pen.”

    The BBC has approached Leonardo for a response.

    The ballot saw all sites support strike action but, in an unusual move, Unite has not immediately announced a date for a walkout but has instead asked for a return to negotiations.

    However, Unite says the walkout will happen this autumn if an improved offer is not made.

    Unite general secretary, Sharon Graham, said: “Our members are highly skilled and work on critical defence and aerospace systems yet are being short-changed by a company making billions.

    “Leonardo needs to do the right thing, return to the negotiating table and make an improved offer our members can accept.

    “Otherwise, they will see their workers on the picket line and their factories shutdown.”

    Leonardo has nine main sites across the UK in Edinburgh, Newcastle, Lincoln, Luton, London, Basildon, Southampton, Bristol and Yeovil.

    It is not the only firm in the aerospace sector to face a staff walkout.

    Last month, Airbus averted strike action by coming up with a new pay deal including enhancements to Unite members’ pensions.

    While Colins Aerospace has agreed a 10% pay increase over 28 months, again avoiding a walkout.

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  • Salesforce to spend $1 billion in Mexico over next five years to drive AI adoption

    Salesforce to spend $1 billion in Mexico over next five years to drive AI adoption

    Oct 8 (Reuters) – Salesforce (CRM.N), opens new tab said on Wednesday it would spend $1 billion in Mexico over the next five years, as the cloud software provider looks to expand its operations and drive artificial intelligence adoption.

    The company, which began operating in Mexico in 2006, said the investment will fund a new Mexico City office and a Global Delivery Center to support customers across the Americas.

    Sign up here.

    “This $1 billion investment is a commitment to Mexico as a key market for AI-powered growth,” CEO Marc Benioff said.

    Mexico is rapidly emerging as a tech services hub, drawing investments from technology companies, particularly in the AI domain due to the country’s proximity to the U.S. and growing talent base.

    Microsoft (MSFT.O), opens new tab announced last year that it will spend $1.3 billion over the next three years to build up its infrastructure in Mexico for cloud computing and AI.

    Salesforce said Mexico is a growth market for the company, with a customer base including organizations such as Xcaret, Grupo Bafar and FEMSA.

    “This investment will not only create jobs and build AI skills within Mexico but will also position our country as a key consultancy hub for markets across Latin America on AI agents and more,” Mexico’s Economy Minister Marcelo Ebrard said.

    Last month, Salesforce forecast third-quarter revenue below Wall Street estimates. The company had also announced a $20 billion increase to its existing share buyback program.

    Salesforce has rolled out AI across its cloud services at a rapid pace, culminating in the 2024 commercial launch of Agentforce — its AI agent platform designed to automate tasks, streamline operations and help lift margins.

    Reporting by Jaspreet Singh in Bengaluru; Editing by Alan Barona

    Our Standards: The Thomson Reuters Trust Principles., opens new tab

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    Access Denied

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    Reference #18.2d91102.1759943422.5699a1b3

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  • Preparing Your Organisation for CSRD Through Strategic Scenario Planning

    Preparing Your Organisation for CSRD Through Strategic Scenario Planning

    Organisations across Europe are navigating a pivotal moment. The accelerating pace of change, driven by political shifts, economic uncertainty, social transformation, rapid technological advances, and intensifying environmental pressures (PESTLE), is demanding bold and resilient leadership. The EU’s Corporate Sustainability Reporting Directive (CSRD),1 alongside sister directives such as the EU’s Pay Transparency Directive2 and the Corporate Sustainability Due Diligence Directive (CSDDD),3 adds to this urgency by setting new benchmarks for how companies account for their social and environmental impacts.

    The CSRD calls for greater transparency around how businesses are measuring and addressing material sustainability risks and impacts, including those related to diversity, equity, inclusion (DEI), and human rights across the value chain. Complying with CSRD requires more than meeting reporting obligations; it demands a deeper understanding of how sustainability and inclusion intersect with business performance and long-term risk.4 But many organisations struggle to build this understanding and embed CSRD’s principles into strategies and practices.

    At the same time, European organisations are keeping a close eye on developments across the Atlantic, where evolving regulatory frameworks — whether directly applicable or indirectly influential — are creating ripple effects that further complicate the compliance landscape. For global organisations, this transatlantic dynamic adds another layer of complexity, reinforcing the need for strategic clarity and adaptive leadership.

    If you are a leader responsible for CSRD, this tool provides a structured way for you to bring together key stakeholders — across HR, DEI, legal, finance, and sustainability — to align priorities and co-develop strategic responses. It supports organisational efforts to address compliance requirements and go further, enabling scenario-based planning that is inclusive, forward-looking, and grounded in cross-functional collaboration.

    This tool will enable you to:

    • Navigate the “S” in ESG through structured scenario planning that aligns with CSRD requirements.
    • Identify and prioritise material social risks and opportunities across the value chain.
    • Stress-test organisational readiness through three future-facing scenarios:
      • Mandatory CSRD disclosures expose existing diversity, equity, and inclusion gaps.
      • AI bias in ESG tools skews CSRD disclosures.
      • Divergence in regulations and budgetary commitment to inclusion across markets complicates CSRD compliance.

    How to cite: Smith, E. & Penda, V. (2025). Preparing your organisation for CSRD through strategic scenario planning. Catalyst.

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  • FDA Grants Fast Track Designation to VT3989 for Unresectable Mesothelioma

    FDA Grants Fast Track Designation to VT3989 for Unresectable Mesothelioma

    The FDA has granted fast track designation to VT3989, a transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor, for the treatment of patients with unresectable malignant nonpleural or pleural mesothelioma who have progressed on prior immune checkpoint inhibition and platinum-based chemotherapy.1

    “We are pleased to receive fast track designation from the FDA for VT3989 in this patient population, which is in desperate need of new and effective therapeutic options,” Sofie Qiao, PhD, president and chief executive officer of Vivace Therapeutics, the developer of VT3989, stated in a news release. “This designation represents another important step in our ongoing development of VT3989 and will offer key advantages as we continue on our path toward potential commercialization of this first-in-class and best-in-class therapy.”

    VT3989 Pipeline Update

    • The FDA granted fast track designation to VT3989, a transcriptional enhanced associate domain (TEAD) autopalmitoylation inhibitor, for the treatment of patients with unresectable malignant nonpleural or pleural mesothelioma who have progressed on prior immune checkpoint inhibition and platinum-based chemotherapy.
    • VT3989 is a novel, investigational small molecule designed to inhibit palmitoylation of members of the TEAD protein family, thereby targeting the Hippo pathway.
    • Preliminary efficacy findings presented from the dose-escalation portion of the ongoing phase 1/2 trial showed decreases in the sum of the target lesions from baseline among patients with both pleural and non-pleural mesothelioma, regardless of their NF2 mutation status.

    What Is the Mechanism of Action of VT3989?

    This novel, investigational small molecule therapeutic is designed to inhibit palmitoylation of members of the TEAD protein family, thus targeting the Hippo pathway. The efficacy and safety of VT3989 are under investigation in an ongoing phase 1/2 clinical trial (NCT04665206).

    What Is the Design of the Phase 1/2 Trial?

    This multicenter, open-label trial is enrolling patients with mesothelioma and/or metastatic solid tumors that are resistant to standard therapy or for which no effective standard therapy is available.2 Patients need to have an ECOG performance status of 0 or 1, as well as adequate organ function.

    This trial consists of 3 parts. The dose-escalation part investigated the safety of VT3989 in patients with mesothelioma or metastatic solid tumors. Patients received the agent in a 3+3 design until the maximum tolerated dose or recommended phase 2 schedule and dose are identified.

    The dose-expansion part assessed the safety and preliminary antitumor activity of VT3989 at the recommended phase 2 schedule and dose in up to 6 cohorts, including patients with mesothelioma of any site origin regardless of NF2 mutation status (cohorts 1 and 2), patients with non-pleural mesothelioma (cohort 3), patients with solid tumors with clearly inactivating NF2 alterations or mutations or YAP/TAZ gene rearrangements (cohort 4), and patients with pleural mesothelioma (cohort 5).

    The combination part will consist of 2 cohorts. Cohort A will enroll patients with mesothelioma who will be treated with VT3989 plus nivolumab (Opdivo) or ipilimumab (Yervoy). Cohort B will enroll patients with non–small cell lung cancer with tumors harboring EGFR exon 19 deletions or EGFR exon 21 L858R mutations who will be treated with VT3989 plus osimertinib.

    VT3989 is administered orally in 25-mg, 50-mg, 100-mg, 150-mg, or 200-mg capsules over 21- or 28-day cycles.

    The primary end point is the occurrence of dose-limiting toxicities and the occurrence of general toxicities. Secondary end points include tumor response; pharmacokinetic evaluations; overall survival in part 2 cohorts 3, 4, and 5; progression-free survival in part 2 cohorts 3, 4, and 5; and quality of life in part 2 cohorts 3, 4, and 5.

    What Is the Efficacy of VT3989 in Patients With Mesothelioma?

    Findings from the dose-escalation portion of the trial, presented at the 2023 IASLC World Conference on Lung Cancer, showed decreases in the sum of the target lesions from baseline among patients with both pleural and non-pleural mesothelioma who received the agent across dose levels and schedules.3 Responses were observed regardless of NF2 mutation status.

    What Is the Safety Profile of VT3989 in Patients With Mesothelioma?

    Among evaluable patients with mesothelioma (n = 44), the most common grade 1 to 4 treatment-related adverse effects included albuminuria (61.6%), proteinuria (59.1%), fatigue (31.8%), peripheral edema (29.5%), nausea (20.5%), increased alanine aminotransferase levels (13.6%), increased aspartate aminotransferase levels (13.6%), anemia (11.4%), and decreased appetite (11.4%).

    References

    1. Vivace Therapeutics’ VT3989 granted fast track designation by the U.S. Food and Drug Administration for the treatment of mesothelioma. News release. Vivace Therapeutics, Inc. October 8, 2025. Accessed October 8, 2025. https://www.prnewswire.com/news-releases/vivace-therapeutics-vt3989-granted-fast-track-designation-by-the-us-food-and-drug-administration-for-the-treatment-of-mesothelioma-302577269.html
    2. Study to evaluate VT3989 in patients with metastatic solid tumors.ClinicalTrials.gov. Updated August 11, 2025. Accessed October 8, 2025. https://clinicaltrials.gov/study/NCT04665206
    3. Yap T, Desai J, Dagogo-Jack I, et al. First-in-human phase 1 trial of VT3989, a first-in-class YAP/TEAD inhibitor in patients with advanced mesothelioma. Presented at: 2023 IASLC World Conference on Lung Cancer. September 9-12, 2023; Singapore.

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