Latest news with #SophieKornowski
Yahoo
02-05-2025
- Business
- Yahoo
Idorsia issues invitation to the 2025 Annual General Meeting of Shareholders
Allschwil, Switzerland – May 2, 2025Idorsia Ltd (SIX: IDIA) today issued the invitation to the upcoming Annual General Meeting (AGM) of Shareholders on behalf of the Board of Directors. The meeting to approve the Annual Report of the year ending December 31, 2024, will be held on Wednesday, May 28, 2025, at 09.00 CEST at the Congress Center, Messe Basel, Switzerland. Jean-Paul Clozel, Chairman of the Board of Idorsia, commented:'The team at Idorsia continues to go the extra mile to secure the company's future. I would like to thank my colleagues on the Board for their dedication and for going beyond what might usually be expected from such a mandate. Dr Sophie Kornowski has decided not to stand for re-election to the Board for personal reasons and I would like to thank Sophie for her contribution over the past two years. I'm pleased to say that all other Board members will stand for re-election. Alongside the regular business, we are proposing to amend the Articles of Association regarding share capital to maintain a significant level of financing flexibility.' Notes to ShareholdersThe invitation was published in the Swiss Official Gazette of Commerce (Schweizerisches Handelsamtsblatt) today and will be distributed to Shareholders by post. It is also available, together with the company's Annual Report, consisting of the Business Report, Governance Report, Compensation Report, Sustainability Report, and Financial Report, at In order to attend and vote at the AGM, shareholders must be registered in the company's shareholder register by May 19, 2025, 17:00 CEST, at the latest. Notes to the editor Agenda for the AGM 20251. Annual reporting 20241.1 Vote on Annual Report 2024, Consolidated Financial Statements 2024, and Statutory Financial Statements 20241.2 Consultative vote on the Compensation Report 20241.3 Consultative vote on the Sustainability Report 20242. Appropriation of available earnings3. Discharge of the Board of Directors and of the Executive Committee4. Amendments to the Articles of Association regarding share capital4.1 Increase of conditional share capital4.2 Amendment of the Capital Range5. Board elections5.1 Re-election of the Board of Directors5.2 Re-election of the Chair of the Board of Directors5.3 (Re-)election of members of the Nominating, Governance & Compensation Committee6. Vote on Board compensation and Executive Committee compensation6.1 Vote on Board compensation for the 2025–2026 term of office6.2 Vote on Executive Committee compensation for 20267. Re-election of the Independent Proxy8. Re-election of the statutory auditors About IdorsiaIdorsia Ltd is reaching out for more – we have more passion for science, we see more opportunities, and we want to help more patients. The purpose of Idorsia is to challenge accepted medical paradigms, answering the questions that matter most. To achieve this, we will discover, develop, and commercialize transformative medicines – either with in-house capabilities or together with partners – and evolve Idorsia into a leading biopharmaceutical company, with a strong scientific core. Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA). For further information, please contactInvestor & Media RelationsIdorsia Pharmaceuticals Ltd, Hegenheimermattweg 91, CH-4123 Allschwil+41 58 844 10 – – The above information contains certain "forward-looking statements", relating to the company's business, which can be identified by the use of forward-looking terminology such as "estimates", "believes", "expects", "may", "are expected to", "will", "will continue", "should", "would be", "seeks", "pending" or "anticipates" or similar expressions, or by discussions of strategy, plans or intentions. Such statements include descriptions of the company's investment and research and development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be introduced by the company and anticipated customer demand for such products and products in the company's existing portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected. Attachment Press Release PDF
Business Wire
28-04-2025
- Health
- Business Wire
Boston Pharmaceuticals to Present the Effect of Efimosfermin Alfa on Collagen Biomarkers in Patients with F2 and F3 MASH at EASL Congress 2025
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Boston Pharmaceuticals, a clinical-stage biopharmaceutical company developing efimosfermin alfa, a once-monthly FGF21 analogue for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), today announced it will present results from an analysis of its Phase 2 study in participants with stage F2 and F3 fibrosis due to MASH. The findings will be presented at the European Association for the Study of the Liver (EASL) Congress 2025, May 7-10, in Amsterdam. "In the analysis, efimosfermin demonstrated improvements in biomarkers related to collagen and a reduction in liver scarring among patients with moderate to advanced liver fibrosis (stages F2-F3) caused by metabolic dysfunction-associated steatotic liver disease," said Rohit Loomba, M.D., MHSc, Professor of Medicine and Chief of the Division of Gastroenterology and Hepatology at University of California, San Diego. 'These data support the histology findings that efimosfermin may have promising effects in treating liver fibrosis in individuals with metabolic liver disease.' As fibrosis progresses, the risk of liver-related morbidity and mortality increases in patients with MASH. This is associated with an imbalance in extracellular matrix (ECM) synthesis and degradation, leading to collagen accumulation in the liver. Improvements in collagen biomarkers over 24 weeks suggest that efimosfermin reduces fibrotic activity, shifting the balance from fibrogenesis to fibrolysis. These results are consistent with histopathology findings presented at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting ® in November 2024, which showed that treatment with once-monthly efimosfermin led to significant improvements in fibrosis ≥1 stage without worsening of MASH, and MASH resolution without worsening of fibrosis, compared to placebo over 24 weeks in participants with biopsy-confirmed F2/F3 MASH. Substantial and rapid improvements in cardiometabolic benefits, such as liver fat reduction and improved glycemic control, were also observed in MASH patients with obesity and diabetes. Efimosfermin was generally well tolerated in the Phase 2 study, with low discontinuation rates due to adverse events, and an overall low incidence of gastrointestinal side effects and injection site reactions. 'We are seeing clear and meaningful improvements in key cardiometabolic and liver biomarkers, as well as a reduction in fibrosis, which is critical for MASH patients,' said Sophie Kornowski, CEO of Boston Pharmaceuticals. 'The continued positive data from our Phase 2 trial reinforces the promise of once-monthly efimosfermin as a transformative therapy for patients with MASH. We are encouraged by the strength of treatment response and the favorable safety profile observed in this trial, which positions us well for upcoming regulatory meetings. Our commitment to developing efimosfermin remains steadfast, and we are excited for the next steps in our journey to improve the lives of those living with this disease.' Details of Boston Pharmaceuticals' presentation at EASL Congress 2025 are as follows: About MASH Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is a growing global epidemic fueled by the increasing prevalence of obesity and type 2 diabetes. It is estimated that MASH affects millions of people worldwide, including 17 million in the U.S., and is expected to increase by 63% by 2030. MASH is a progressive disease staged by the degree of fibrosis (scarring) in the liver and is closely associated with multiple cardiometabolic risk factors. Left untreated, MASH could lead to liver failure, liver cancer, or death. In the U.S., MASH is becoming the leading cause of liver transplantation. About efimosfermin alfa Boston Pharmaceuticals' lead investigational agent, efimosfermin alfa, is a once-monthly subcutaneous injection of a long-acting variant of human fibroblast growth factor 21 (FGF21) that regulates various metabolic pathways to decrease liver fat, ameliorate liver inflammation, and reverse liver fibrosis in patients with MASH. Efimosfermin is manufactured in mammalian cells, leading to human-like glycosylation. Efimosfermin is currently in Phase 2 clinical trials for the treatment of MASH. In a 24-week Phase 2 study of subjects with moderate to advanced (stage F2 and F3) fibrosis due to MASH, efimosfermin has demonstrated statistically significant improvements in liver fibrosis and MASH resolution, reductions in liver fat content, improved markers of liver injury and metabolic biomarkers, with a favorable safety profile. The most frequently reported treatment-emergent adverse events were gastrointestinal events and were predominantly mild to moderate. About Boston Pharmaceuticals Boston Pharmaceuticals, a portfolio company of B-FLEXION, is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey. For more information, please visit and follow us on LinkedIn. Forward-Looking Statement This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. This communication, other than statements of historic fact, are forward-looking statements. Boston Pharmaceutical's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory or prove to be commercially successful. Boston Pharmaceuticals does not undertake to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this presentation except as required by law.
Business Wire
23-04-2025
- Business
- Business Wire
Boston Pharmaceuticals to Present State-of-the-Art Lecture and Poster for Once-monthly Efimosfermin Alfa at Digestive Disease Week ® 2025
BUSINESS WIRE)-- Boston Pharmaceuticals, a clinical-stage biopharmaceutical company developing efimosfermin alfa, an investigational, once-monthly FGF21 analogue for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), today announced it will present immunogenicity and biomarker analyses from its Phase 2 study, in participants with stage F2 and F3 fibrosis due to MASH. The results will be presented in a state-of-the-art lecture and poster at Digestive Disease Week (DDW) in San Diego, May 3-6, 2025. These findings further support the advancement of the efimosfermin clinical program to a Phase 3 pivotal study in 2025. 'Efimosfermin has demonstrated rapid and strong response across liver and cardiometabolic biomarkers, along with a favorable safety and tolerability profile. Its once-monthly dosing is expected to be a significant advantage for both prescribers and patients, providing confidence that efimosfermin could set a new standard in MASH treatment,' said Sophie Kornowski, CEO of Boston Pharmaceuticals. 'With our robust data, along with the commitment from our Board and a strong funding strategy, we aim to accelerate efimosfermin's development and begin enrolling patients in a Phase 3 study in F2 and F3 patients before the end of the year, followed by an F4 trial after planned discussions with regulators.' The state-of-the-art oral presentation will showcase results from the Phase 2, randomized, placebo-controlled, 24-week treatment study in participants with biopsy-confirmed F2 and F3 MASH. The study showed significant improvements in histopathology, with 45.2% (p=0.038) of participants treated with efimosfermin 300mg achieving fibrosis improvement ≥1 stage without worsening of MASH compared to 20.6% in the placebo group, and MASH resolution without worsening of fibrosis in 67.7% of participants (p=0.002) versus 29.4% at 24 weeks. Efimosfermin also demonstrated extrahepatic benefits, including positive impacts on lipids and in participants with diabetes, clinically meaningful improvements in glycemic control. In this study, efimosfermin was generally well-tolerated, with low discontinuation rates due to adverse events, and an overall low incidence of gastrointestinal side effects and injection site reactions. Data to be presented will also highlight the favorable immunogenicity profile of efimosfermin. Exploratory analyses of the phase 2 study of changes in biomarkers that identify at-risk MASH patients will be presented as a poster. These results strengthen the histopathology findings, demonstrating rapid and marked effects on biomarkers of steatosis, fibrosis, and liver injury, and supports the potential of efimosfermin as a once-monthly, disease-modifying therapeutic for the treatment of MASH. 'These analyses further support the Phase 2 study findings and provides the scientific community with the confidence to advance the development of efimosfermin as a potential therapy for patients with F2 and F3 fibrosis,' said Mazen Noureddin, M.D., lead investigator and Professor of Medicine at Houston Methodist Hospital, and Director of the Houston Research Institute. 'Based on these encouraging results, we expect to see continued progress as we evaluate findings across histology and non-invasive markers in patients with F2 and F3 MASH receiving efimosfermin treatment for up to 48 weeks.' Details of Boston Pharmaceuticals' presentations are as follows: Digestive Disease Week 2025 Oral Presentation Title: Once-Monthly Efimosfermin Alfa (BOS-580) in Metabolic Dysfunction-Associated Steatohepatitis With F2/F3 Fibrosis: Results From a 24 Week, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial Abstract Number: 723 Session: State-of-the-Art Lecture: Update on MASLD Therapies Pipeline Session Date, Time: Monday, May 5, 2025, 10:00 a.m. – 11:30 a.m. PDT Presentation Time: 11:05 a.m. – 11:20 a.m. PDT Location: 6F Presenter: Matthew Bryant, PharmD, Vice President of Medical Affairs, Boston Pharmaceuticals Expand Poster Presentation Title: Once-Monthly Efimosfermin Alfa Improves FAST and FIB-4 Composite Biomarker Scores for MASH Stage F2-F3 Fibrosis in a 24-Week Phase 2 Trial Abstract Number: Sa1504 Session: Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH) Session Date, Time: Location: Halls C-E Presenter: Rohit Loomba, M.D., MHSc, Professor of Medicine, Chief in the Division of Gastroenterology and Hepatology, and Director of MASLD Research Center at University of California, San Diego Expand About MASH Metabolic dysfunction-associated steatohepatitis (MASH), formerly known as non-alcoholic steatohepatitis (NASH), is a growing global epidemic fueled by the increasing prevalence of obesity and type 2 diabetes. It is estimated that MASH affects millions of people worldwide, including 17 million in the U.S., and is expected to increase by 63% by 2030. MASH is a progressive disease staged by the degree of fibrosis (scarring) in the liver and is closely associated with multiple cardiometabolic risk factors. Left untreated, MASH could lead to liver failure, liver cancer or death. In the U.S., MASH is now a leading cause of liver transplantation. About efimosfermin alfa Boston Pharmaceuticals' lead investigational agent, efimosfermin alfa (formerly BOS-580) is a once-monthly subcutaneous injectable of a long-acting variant of human fibroblast growth factor 21 (FGF21) that regulates various metabolic pathways to decrease liver fat and ameliorate liver inflammation and damage in patients with metabolic dysfunction-associated steatohepatitis (MASH), also known as non-alcoholic steatohepatitis (NASH). The Phase 2 clinical development program of efimosfermin is continuing with an open-label extension in F2 and F3 MASH patients, providing an additional 24 weeks of treatment to assess long-term safety and efficacy up to 48 weeks. Boston Pharmaceuticals also plans to initiate a supplemental study in F4 MASH to further expand and enrich the data set for this patient population. About Boston Pharmaceuticals Boston Pharmaceuticals, a portfolio company of B-FLEXION, is a clinical-stage biopharmaceutical company that leverages an experienced and committed drug development team to advance a portfolio of highly differentiated therapies that may address important unmet medical needs in serious liver diseases, with MASH as the focus of its lead asset. The Company has significant expansion opportunities through its portfolio of promising drug development candidates that were acquired through partnerships with proven, innovative biotechnology and pharmaceutical companies. Boston Pharmaceuticals applies rigorous decision-making to advance programs to deliver differentiated medicines to patients in need of new options while creating value for all parties involved in the journey. For more information, please visit and follow us on LinkedIn. Forward-Looking Statement This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. This communication, other than statements of historic fact, are forward-looking statements. Boston Pharmaceutical's actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that any product will receive or maintain regulatory approval in any territory or prove to be commercially successful. Boston Pharmaceuticals does not undertake to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this presentation except as required by law.
