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Italfarmaco Announces U.S. FDA Grants Fast Track Designation to Givinostat in Treatment of Polycythemia Vera - ForexTV
MILAN, Italy, May 6, 2025 – Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to givinostat for the treatment of patients with polycythemia vera (PV), a rare haematologic cancer, for which treatment options are limited.“The FDA decision to grant givinostat Fast Track designation underscores the urgent need for innovative treatments for PV and highlights the potential of givinostat to make a meaningful difference,” said Paolo Bettica, MD, PhD, Chief Medical Officer at Italfarmaco Group. “We look forward to working closely with the FDA as we plan for completion of our Phase III clinical trial.”Givinostat is an orally administered histone deacetylase inhibitor (HDACi) with potential applications in both neuromuscular disorders and oncology. HDACis work by modulating key cellular pathways that regulate gene expression, offering promising therapeutic benefits across a range of diseases. Givinostat is currently being studied for its potential to treat PV, a rare blood cancer characterised by the overproduction of erythroid, myeloid, and megakaryocytic components in the bone marrow. PV commonly causes symptoms like headache, weakness, and itching, with severe complications including stroke, heart attack, and deep vein thrombosis, which are leading causes of mortality. Furthermore, PV carries a variable risk of progression to myelofibrosis or acute myeloid leukaemia. By targeting and modulating abnormal gene expression, givinostat may help control excessive cell proliferation driven by mutations such as JAK2V617F, commonly found in PV patients. This mechanism aims to reduce disease burden, alleviate symptoms, and improve long-term outcomes. The Phase III trial (NCT06093672) is currently enrolling patients with clinical sites open in Europe, the UK, Israel, and North America, with more sites expected soon.FDA Fast Track designation is a process designed to facilitate the development and expedite the review of new drugs or biologics that are intended to treat serious or life-threatening conditions and address unmet medical needs. This designation aims to accelerate the drug development and review process by encouraging early and frequent communication between the FDA and drug companies.Givinostat has received orphan drug designation by the FDA and the European Medicines Agency (EMA) for PV. In addition, givinostat (Duvyzat®) has marketing authorisations for Duchenne muscular dystrophy from the FDA and the MHRA1, with a positive opinion adopted by the CHMP2 and other regulatory processes currently ongoing.About ITALFARMACO Founded in 1938 in Milan, Italy, Italfarmaco is a private global pharmaceutical company that has led the successful development and approval of many pharmaceutical products around the world. The Italfarmaco group has operations in more than 60 countries through directly controlled or affiliated companies. The company is a leader in pharmaceutical research, product development, production and commercialisation with proven success in many therapeutic areas including immuno-oncology, gynaecology, neurology, cardiovascular disease and rare diseases. Italfarmaco's rare disease unit includes programmes in Duchenne muscular dystrophy, Becker muscular dystrophy, amyotrophic lateral sclerosis and polycythaemia vera. Media enquiries:Anja Heuer / Jacob Verghese |+49 (0) 151 106 199 05 | italfarmaco@trophic.eu Other enquiries:Patient Advocacy and Communications Lead| s.parker@italfarmacogroup.com [1] UK’s Medicines and Healthcare products Regulatory Agency[2] European Medicines Agency Committee for Medicinal Products for Human Use Attachment Italfarmaco Press Release Givinostat Fast Track Designation FDA
UK Financial Sector Unites to Fund Commercial Variable Recurring Payments (VRPs) UK Financial Sector Unites to Fund Commercial Variable Recurring Payments (VRPs)
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Lead Service Line Replacement Cost Calculator (LSLRCC) Federal Trademark and Copyright Applications Filed by Environmental & Public Health International - ForexTV
Pending federal protections aim to preserve a powerful tool, shaped by lessons from the Flint Water Crisis, to help local governments replace 9.2 million lead service lines across the United StatesCHICAGO, May 12, 2025 (GLOBE NEWSWIRE) -- Environmental & Public Health International (EPHI), a leader in drinking water training focused on the lessons of the Flint Water Crisis, has filed for federal trademark and copyright protection for the Lead Service Line Replacement Cost Calculator (LSLRCC), reaffirming its commitment to preserving the tool as a public resource designed to support local government efforts to replace the 9.2 million lead service lines in the United States. This powerful, multilingual tool—available in both English and Spanish—enables municipalities, public water systems, and infrastructure planners to generate customized cost estimates using project-specific inputs. With an intuitive, user-friendly interface, the LSLRCC empowers communities of all sizes to model costs across various scenarios and: Generate customized estimates based on service line counts, labor, contingency costs, and other variablesConduct scenario planning to evaluate multiple funding strategies and replacement timelinesCompare project costs easily without requiring technical expertiseAccess the tool freely online, ensuring planning support for all communitiesNavigate in English or Spanish, increasing accessibility Created under the leadership of Anthony Ross—former EPA Flint Emergency Coordinator, the LSLRCC was shaped by firsthand experience in Flint and a deep understanding of the importance of improving drinking water infrastructure throughout the United States. During his time as EPA’s Flint Emergency Coordinator, Ross helped guide compliance with the Safe Drinking Water Act and worked closely with local and state officials to accelerate lead service line replacement in the wake of the Flint Water Crisis. Sponsorship opportunities are now open to mission-aligned public agencies, nonprofit organizations, and private-sector leaders dedicated to supporting nationwide efforts to replace lead service lines. To learn more, download our Sponsor Kit. By partnering with us, sponsors will play a key role in shaping the future of drinking water infrastructure. Sponsorship Opportunities:We are offering exclusive sponsorship opportunities to mission-aligned public agencies, nonprofit organizations, and private sector companies passionate about safeguarding public health, improving drinking water infrastructure, and promoting community well-being. By sponsoring the Lead Service Line Replacement Cost Calculator, your organization will gain visibility as a leader in the national effort to replace lead service lines and protect millions of Americans. Sponsorship is ideal for: Public Sector: Local, state, and federal agencies dedicated to improving public health and infrastructure.Nonprofit Organizations: Advancing environmental health, improving drinking water quality, and advocating for continuous public policy improvements.Private Sector: Companies in water services, construction, engineering, environmental consulting, and related industries seeking to make a lasting impact. Sponsors will enjoy prominent hyperlinked logo placement above or below the calculator, along with recognition in national press releases. Join us in building a lead-free future. Stand alongside national leaders working to protect public health. View our Sponsor Kit to learn how your organization can make a visible and lasting impact. Insights From Leadership: “Filing for federal trademark and copyright protection for the Lead Service Line Replacement Cost Calculator is part of our long-term commitment to ensure that the LSLRCC continues to serve as a free, public resource to the American people, supporting local government efforts to remove the 9.2 million lead service lines across the United States,” said Ross. Flint Drinking Water Training Updates:Join us on June 5, 2025, at 11 AM ET for an online drinking water training session, where we’ll explore lessons learned from the Flint Water Crisis—a critical examination of what went wrong, the key missteps, and the essential strategies to prevent future public health failures. Gain firsthand insights into the Flint Water Crisis, learn from past mistakes, and discover strategies to prevent future crises. Register now to secure your spot for this essential drinking water training session. About EPHI:Environmental & Public Health International (EPHI) is a leader in drinking water training, delivering experience-based training shaped by the Flint Water Crisis. Our mission is to provide specialized training to regulators and public water systems, supporting their efforts to safeguard public health and prevent future catastrophic drinking water failures. For more information, please visit our Privacy Policy, Terms & Conditions, Registration Form, Survey, or Contact Us page. You can access the original press release in the News Section of EPHI’s website. Previous press releases from April 29, 2025, and March 31, 2025, are also available. CONTACT: Media Contact: Anthony Ross Environmental & Public Health International Email: anthony.ross@ephillc.com Phone: 312.248.1416 Website: https://ephillc.com/
Sisecam’s net sales amounted to 45 billion TRY in the first three months of the year - ForexTV
Sisecam a global player in its sector, achieved consolidated net sales of TRY 45 billion in the first three months of 2025. The Company’s international sales represented 63% of its total sales. During the same period, Sisecam reported total investments of TRY 7.7 billion and exports amounting to USD 230 million. Sisecam CEO Can Yucel Sisecam CEO Can Yucel ISTANBUL, May 13, 2025 (GLOBE NEWSWIRE) -- Sisecam announced financial results for the first three months of 2025. In the three-month period, Sisecam’s consolidated net sales totaled TRY 45 billion. International sales- comprising the total of exports made from Türkiye and sales from production facilities outside Türkiye- accounted for 63% of consolidated sales. Sisecam’s total investments in the same period amounted to TRY 7.7 billion while exports totaled USD 230 million. Sisecam produced 1.3 million tons of glass, 1.1 million tons of soda ash, and 0.8 million tons of industrial raw materials in the same period. A dust cloud has risen over global trade, visibility has decreased Commenting on the first three months of 2025, Sisecam CEO, Can Yucel, said: “The first quarter of 2025 emerged as a period where global risks and uncertainties have once again increased. In particular, the escalating trade tensions between the United States and China, and the potential impact of tariffs on Europe and many other countries, carry the potential to disrupt entire global supply chains. A figurative dust cloud has risen over global trade. Visibility has decreased and uncertainty has been raised as an issue once again. At Sisecam we generate 12% of our total sales through our manufacturing operations in the U.S. and 8% of our exports are directed to the U.S. market. Therefore, we are closely monitoring these developments. However, even during this turmoil, we continue to act with composure and a strategic perspective, without losing our focus. Because we know that this dust will eventually settle. When that moment arrives, the landscape before us will be much clearer. At that point, we will not only be able to define risks more effectively, but we will also step into a new phase, one where we can seize emerging opportunities with greater strength.” The era of measured agility Emphasizing that this new era demands not only managing risks but also the ability to make use of opportunities amid uncertainty, Yucel continued: “We have proudly spoken of being a well-established and an agile organization so far. Today, we are adding a measured and prudent approach to these aspects. Being agile is important, but taking the right step at the right time, and being cautious also directly influence success. With this mindset, Sisecam’s decision-making core is more active than ever. We are tracking global developments in real-time, developing multidimensional scenarios, and building our decisions on solid foundations. Our strategic intuition and effective decision-making are among our greatest advantages in both risk management and capitalizing on opportunities. Throughout this process, we are acting with strict discipline in all areas under our control to minimize the impact of external variables. Cost management, budget alignment, operational efficiency, and financial resilience are our primary areas of focus. Our decision to carry out an early cold repair at our flat glass plant in Northern Italy is a concrete example of this strategic approach. If necessary, we will not hesitate to implement similar decisions in other geographies as well.” We swiftly adapt our strategy to change Highlighting that production performance remained stable in the first three months and that capacity utilization was preserved while efficiency-focused projects gained momentum, Yucel said:“The strategic steps we have taken in digitalization and sustainability reflect our dedication not only to navigating the present, but also to shaping the future. Thanks to the flexibility provided by our geographical diversity, we are not only spreading risks but also effectively tapping into the potential of different markets. For instance, the recently announced additional tariff obligations that vary by country may offer us cost-based advantages in our international sales operations, as a company with production in multiple geographies. This robust structure ensures that no single development can significantly impact our overall performance. Today, Sisecam is focusing on the future more strongly than ever. We are not just solving today’s problems; we are also moving forward with the goal of becoming the leader of tomorrow. We are well-prepared to face challenges, empowered by our experience, capabilities, and unwavering determination.” A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/85ddb4e4-eeca-4867-9ed8-b0005e1348ad CONTACT: Ayşegül Akyarlı AAKYARLI@sisecam.com
Quotation of the Day... - Cafe Hayek
Tweet… is from page 203 of the late Robert Bartley’s 1992 book about America during the years 1983 through 1989, The Seven Fat Years: There is, however, no significant way to shove capital into the Third World. It has to be pulled. The crucial variable is the economic policies of Third World nations. If their […]
AB “Ignitis grupė” Strategic Plan 2025–2028: paving the way towards 100% green and secure energy ecosystem - ForexTV
AB “Ignitis grupė” (hereinafter – the Group) publishes its Strategic Plan 2025–2028, which is attached to this notice. The Group remains committed to executing its ambitious strategy with the purpose to create a 100% green and secure energy ecosystem for current and future generations.We are continuing to expand the Group’s Green Capacities Portfolio to reach 4–5 GW of installed Green Capacities by 2030, thus strengthening the energy security and contributing to the surplus green energy production in the region. In the Networks segment, we are expanding and maintaining the electricity grid to facilitate green transition. Highlights of the strategic planWe target to double the installed Green Capacities, reaching a total of 2.6–3.0 GW in 2028 compared to 1.4 GW in 2024. Currently, the Group’s Green Capacities Portfolio amounts to 8.4 GW, of which 3.1 GW is Secured Capacity. We focus on the development of green generation and green flexibility technologies – onshore and offshore wind, batteries, pumped-storage hydro and power-to-x. To enable the Green Capacities build-out, we utilise and further expand our customer base to ensure electricity offtake. Expanding the electricity supply portfolio in the countries we are active in should lead to a significant increase in the amount of supplied electricity by the Group, from 6.7 TWh in 2024 to 9.0–11.0 TWh by 2028. Also, the Group continues to build a leading EV fast-charging network, being the first-choice provider of charging solutions in the Baltics for home and business customers.In the Networks segment, we are focusing on ensuring resilient and efficient electricity distribution and electricity network expansion to facilitate the energy market. And through the Reserve Capacities segment, we ensure the reliability and security of the power system.Financial targetsIn 2025–2028, we plan to invest EUR 3.0–4.0 billion with over 85–90% of the Investments to be aligned with the EU Taxonomy. We plan to direct around 59% of the Investments (EUR 1.7–2.4 billion) to further develop Green Capacities. More than half of the Investments in Green Capacities over the 2025–2028 period relate to new installed Green Capacities additions after 2028.The second largest portion, around 36%, of the Investments (EUR 1.2–1.3 billion) is to be directed towards the expansion and maintenance of a resilient and efficient electricity distribution network, which is one of the key elements of a successful energy transition.The Investments should translate into EUR 600–680 million Adjusted EBITDA in 2028, up from EUR 527.9 million in 2024. We aim to achieve a sustainable share of Adjusted EBITDA of at least 70–75% by 2028. The average Adjusted ROCE is expected to be within 6.5–7.5% in 2025–2028.We target to maintain our credit rating of ‘BBB’ and above over the 2025–2028 period, supported by disciplined financial management. We will continue our investment program while maintaining the Net Debt to Adjusted EBITDA ratio below 5 times.In line with the Dividend Policy, we are committed to a minimum of 3% annual dividend growth, implying a 6.4%–7.0% dividend yield for the 2025–2028 period.Sustainability priorities and targetsWe target to reach net zero emissions by 2040–2050. We will maximise sustainable value by directing our investments toward a decarbonisation pathway that is aligned with our business ambitions and reaching net zero emissions by 2040–2050. Our sustainability-related priority is reducing the carbon intensity of our Scope 1 & 2 GHG emissions (to 190 g CO2-eq/kWh in 2028 or reducing by 5% vs. 2024) by growing installed Green Capacities and increasing the share of green electricity used for our operations. Long-term performance objectivesFollowing the Strategic Plan, the Supervisory Board of Ignitis Group approved the long-term objectives and performance targets for the 2025–2028 period that determine the long-term variable part of remuneration for key executives.The details of the Long-Term Incentive Plan objectives for the 2025–2028 period are available in the Strategic Plan’s annexes and on our website. Earnings call In relation to the announcement of the First three months 2025 interim report and Strategic Plan 2025–2028, an earnings call for investors and analysts will be held on Wednesday, 14 May 2025, at 1:00 pm Vilnius / 11:00 am London time. To join the earnings call, please register at: https://edge.media-server.com/mmc/go/Ignitis3M2025resultsandStrategicPlan2025-2028It will be also possible to join the earnings call by phone. To access the dial-in details, please register here. After completing the registration, you will receive dial-in details on screen and via email. You will be able to dial in using the provided numbers and a unique pin or by selecting ‘Call me’ option and providing your phone details for the system to connect you automatically as the earnings call starts. All questions of interest can be directed to the Group’s Investor Relations team in advance, after registration or live during the earnings call. Presentation slides will be available for download prior the call at:https://ignitisgrupe.lt/en/reports-presentations-and-fact-sheets The First three months 2025 interim report, fact sheet (in Excel) and other published documents will be available for download at:https://ignitisgrupe.lt/en/reports-presentations-and-fact-sheets Strategic Plan 2025–2028 will be available for download at:https://ignitisgrupe.lt/en/about-us/strategy For additional information, please contact: CommunicationsValdas Lopeta+370 621 77993valdas.lopeta@ignitis.ltInvestor RelationsAinė Riffel-Grinkevičienė+370 643 14925aine.riffel-grinkeviciene@ignitis.lt Attachment Ignitis Group Strategic Plan 2025-2028
AB “Ignitis grupė” Strategic Plan 2025–2028: paving the way towards 100% green and secure energy ecosystem - ForexTV
AB “Ignitis grupė” (hereinafter – the Group) publishes its Strategic Plan 2025–2028, which is attached to this notice. The Group remains committed to executing its ambitious strategy with the purpose to create a 100% green and secure energy ecosystem for current and future generations.We are continuing to expand the Group’s Green Capacities Portfolio to reach 4–5 GW of installed Green Capacities by 2030, thus strengthening the energy security and contributing to the surplus green energy production in the region. In the Networks segment, we are expanding and maintaining the electricity grid to facilitate green transition. Highlights of the strategic planWe target to double the installed Green Capacities, reaching a total of 2.6–3.0 GW in 2028 compared to 1.4 GW in 2024. Currently, the Group’s Green Capacities Portfolio amounts to 8.4 GW, of which 3.1 GW is Secured Capacity. We focus on the development of green generation and green flexibility technologies – onshore and offshore wind, batteries, pumped-storage hydro and power-to-x. To enable the Green Capacities build-out, we utilise and further expand our customer base to ensure electricity offtake. Expanding the electricity supply portfolio in the countries we are active in should lead to a significant increase in the amount of supplied electricity by the Group, from 6.7 TWh in 2024 to 9.0–11.0 TWh by 2028. Also, the Group continues to build a leading EV fast-charging network, being the first-choice provider of charging solutions in the Baltics for home and business customers.In the Networks segment, we are focusing on ensuring resilient and efficient electricity distribution and electricity network expansion to facilitate the energy market. And through the Reserve Capacities segment, we ensure the reliability and security of the power system.Financial targetsIn 2025–2028, we plan to invest EUR 3.0–4.0 billion with over 85–90% of the Investments to be aligned with the EU Taxonomy. We plan to direct around 59% of the Investments (EUR 1.7–2.4 billion) to further develop Green Capacities. More than half of the Investments in Green Capacities over the 2025–2028 period relate to new installed Green Capacities additions after 2028.The second largest portion, around 36%, of the Investments (EUR 1.2–1.3 billion) is to be directed towards the expansion and maintenance of a resilient and efficient electricity distribution network, which is one of the key elements of a successful energy transition.The Investments should translate into EUR 600–680 million Adjusted EBITDA in 2028, up from EUR 527.9 million in 2024. We aim to achieve a sustainable share of Adjusted EBITDA of at least 70–75% by 2028. The average Adjusted ROCE is expected to be within 6.5–7.5% in 2025–2028.We target to maintain our credit rating of ‘BBB’ and above over the 2025–2028 period, supported by disciplined financial management. We will continue our investment program while maintaining the Net Debt to Adjusted EBITDA ratio below 5 times.In line with the Dividend Policy, we are committed to a minimum of 3% annual dividend growth, implying a 6.4%–7.0% dividend yield for the 2025–2028 period.Sustainability priorities and targetsWe target to reach net zero emissions by 2040–2050. We will maximise sustainable value by directing our investments toward a decarbonisation pathway that is aligned with our business ambitions and reaching net zero emissions by 2040–2050. Our sustainability-related priority is reducing the carbon intensity of our Scope 1 & 2 GHG emissions (to 190 g CO2-eq/kWh in 2028 or reducing by 5% vs. 2024) by growing installed Green Capacities and increasing the share of green electricity used for our operations. Long-term performance objectivesFollowing the Strategic Plan, the Supervisory Board of Ignitis Group approved the long-term objectives and performance targets for the 2025–2028 period that determine the long-term variable part of remuneration for key executives.The details of the Long-Term Incentive Plan objectives for the 2025–2028 period are available in the Strategic Plan’s annexes and on our website. Earnings call In relation to the announcement of the First three months 2025 interim report and Strategic Plan 2025–2028, an earnings call for investors and analysts will be held on Wednesday, 14 May 2025, at 1:00 pm Vilnius / 11:00 am London time. To join the earnings call, please register at: https://edge.media-server.com/mmc/go/Ignitis3M2025resultsandStrategicPlan2025-2028It will be also possible to join the earnings call by phone. To access the dial-in details, please register here. After completing the registration, you will receive dial-in details on screen and via email. You will be able to dial in using the provided numbers and a unique pin or by selecting ‘Call me’ option and providing your phone details for the system to connect you automatically as the earnings call starts. All questions of interest can be directed to the Group’s Investor Relations team in advance, after registration or live during the earnings call. Presentation slides will be available for download prior the call at:https://ignitisgrupe.lt/en/reports-presentations-and-fact-sheets The First three months 2025 interim report, fact sheet (in Excel) and other published documents will be available for download at:https://ignitisgrupe.lt/en/reports-presentations-and-fact-sheets Strategic Plan 2025–2028 will be available for download at:https://ignitisgrupe.lt/en/about-us/strategy For additional information, please contact: CommunicationsValdas Lopeta+370 621 77993valdas.lopeta@ignitis.ltInvestor RelationsAinė Riffel-Grinkevičienė+370 643 14925aine.riffel-grinkeviciene@ignitis.lt Attachment Ignitis Group Strategic Plan 2025-2028