Metabolic dysfunction - associated steatohepatitis (MASH)
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Inventiva to Participate in Four Upcoming March Investor Conferences
Globenewswire· 2026-02-26 21:00
Daix (France), New York (United States), February 26, 2026 – Inventiva (Euronext Paris and NASDAQ: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of an oral therapy for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced that the Company’s leadership will participate in one-on-one meetings and presentations during the following upcoming investor events: TD Cowen 46th Annual Health Care Conference – March 2-4, ...
Altimmune to Report Fourth Quarter and Full Year 2025 Financial Results and Provide Business Update on March 5, 2026
Globenewswire· 2026-02-26 12:30
GAITHERSBURG, Md., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing pemvidutide to address serious liver diseases, today announced that it will report its fourth quarter 2025 financial results on Thursday, March 5, 2026. Altimmune management will host a conference call at 8:30 a.m. ET on March 5 to discuss the financial results and provide a business update. The conference call will be webcast live on Altimmune’s Investor Relations w ...
Madrigal Expands its MASH Pipeline with Exclusive Global Licensing Agreement for Six Preclinical siRNA Programs
Globenewswire· 2026-02-11 10:00
Core Viewpoint - Madrigal Pharmaceuticals has entered an exclusive global license agreement with Suzhou Ribo Life Science for six preclinical small interfering RNA (siRNA) programs aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [1][6] Company Overview - Madrigal Pharmaceuticals is focused on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [14] - The company’s lead product, Rezdiffra (resmetirom), is the first medication approved for MASH with moderate to advanced fibrosis [14] - Madrigal's pipeline now includes over 10 programs targeting various drivers of MASH, with Rezdiffra serving as the foundational therapy [2][3] Research and Development Strategy - The R&D strategy emphasizes innovative compounds targeting validated mechanisms of disease to improve patient outcomes [2] - siRNAs are highlighted for their precision in gene silencing, potentially complementing the effects of Rezdiffra [3][5] - The company plans to initiate IND-enabling activities for initial siRNA candidates in 2026 [5] Financial Aspects - Ribo will receive an upfront payment of $60 million, with potential cumulative payments reaching $4.4 billion based on milestone achievements, in addition to royalties on net sales [6] Market Context - MASH is a leading cause of liver transplantation, particularly among women, and is rapidly growing in prevalence [7][9] - Patients with moderate to advanced liver fibrosis face significantly higher risks of liver-related mortality, underscoring the urgency for effective treatments [8] Product Information - Rezdiffra is prescribed alongside diet and exercise for adults with MASH and is currently undergoing studies to confirm its clinical benefits [10]
Inventiva to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-04 21:00
Core Insights - Inventiva, a clinical-stage biopharmaceutical company, focuses on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1][2] - CEO Andrew Obenshain will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11-12, 2026, in New York City [1][2] Company Overview - Inventiva is engaged in the research and development of oral small molecule therapies targeting MASH and other diseases with significant unmet medical needs [2] - The company is currently evaluating lanifibranor, a novel pan-PPAR agonist, in the NATiV3 pivotal Phase 3 clinical trial for adult patients with MASH [2] Stock Information - Inventiva is publicly listed on Euronext Paris (ticker: IVA) and the Nasdaq Global Market in the United States (ticker: IVA) [3]
Madrigal Pharmaceuticals to Release Fourth-Quarter and Full-Year 2025 Financial Results and Host Webcast on February 19, 2026
Globenewswire· 2026-02-02 13:05
Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its fourth-quarter and full-year 2025 financial results on February 19, 2026, prior to the opening of U.S. financial markets [1] Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist aimed at addressing key underlying causes of MASH [3] - Rezdiffra is the first and only medication approved by both the FDA and European Commission for treating MASH with moderate to advanced fibrosis (F2 to F3) [3] - An ongoing Phase 3 outcomes trial is currently evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [3]
Madrigal Expands its MASH Pipeline with Exclusive Global License Agreement for Ervogastat, a Phase 2 Oral DGAT-2 Inhibitor
Globenewswire· 2026-01-09 13:00
Core Viewpoint - Madrigal Pharmaceuticals has entered into an exclusive global license agreement with Pfizer for ervogastat, a clinical-stage oral DGAT-2 inhibitor, enhancing its position in the development of therapies for metabolic dysfunction-associated steatohepatitis (MASH) [1][4]. Company Developments - The agreement allows Madrigal to develop, manufacture, and commercialize ervogastat, along with rights to two additional early-stage MASH pipeline assets. Pfizer received an upfront payment of $50 million, with potential additional payments and royalties based on net sales [4]. - Madrigal plans to present further details at the 44th Annual J.P. Morgan Healthcare Conference on January 12, 2026 [2][5]. Product Information - Ervogastat is a liver-directed oral DGAT-2 inhibitor that lowers hepatic triglycerides and reduces liver inflammation. In a Phase 2 study, 72% of patients achieved at least a 30% reduction in liver fat, and 61% achieved at least a 50% reduction [3][4]. - The combination of ervogastat with Madrigal's existing product, Rezdiffra, is expected to provide additive therapeutic benefits due to their complementary mechanisms of action [3][5]. Industry Context - MASH is a serious liver disease that can lead to severe complications, including cirrhosis and liver cancer. It is the leading cause of liver transplantation in women in the U.S. and is increasingly recognized as a significant health issue [6][7]. - As awareness of MASH increases, the number of diagnosed patients with moderate to advanced fibrosis is expected to grow, highlighting the need for effective treatment options [8].
Inventiva announces temporary trading halt of its ordinary shares on Euronext Paris
Globenewswire· 2025-11-13 07:40
Core Points - Inventiva, a clinical-stage biopharmaceutical company, announced a temporary halt in trading of its ordinary shares on Euronext Paris due to a public offering of new American Depositary Shares (ADSs) in the United States [1][2] - The trading halt is expected to last until approximately 3:30 p.m. CET on November 13, 2025, when trading is anticipated to resume [2] - Inventiva is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently evaluating lanifibranor in a pivotal Phase 3 clinical trial [3] Company Overview - Inventiva is listed on Euronext Paris and the Nasdaq Global Market, focusing on oral small molecule therapies for MASH [3][4] - The company is conducting research on lanifibranor, a novel pan-PPAR agonist, aimed at treating adult patients with MASH, a progressive chronic liver disease [3]
Altimmune Announces Publication of IMPACT Phase 2b Trial Data in The Lancet and Concurrent Late-Breaking Oral Presentation at AASLD The Liver Meeting® 2025
Globenewswire· 2025-11-11 13:51
Core Insights - Altimmune, Inc. announced significant 24-week efficacy and safety data from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), showing promising results in MASH resolution, weight loss, and anti-fibrotic activity [1][3][5] Group 1: Trial Results - The IMPACT Phase 2b trial demonstrated that pemvidutide achieved statistically significant MASH resolution without worsening fibrosis, with 58% and 52% of patients in the 1.2 mg and 1.8 mg groups respectively achieving this outcome compared to 20% in the placebo group [6] - Significant improvements were observed in secondary endpoints, including a reduction in liver stiffness measurement and Enhanced Liver Fibrosis score, with the 1.2 mg and 1.8 mg groups showing reductions of -3.7 kPa and -2.2 kPa respectively [6] - The trial also reported a normalization of liver fat content in 31% and 44% of patients in the 1.2 mg and 1.8 mg groups respectively, compared to only 4% in the placebo group [6] Group 2: Safety and Tolerability - Pemvidutide exhibited a favorable tolerability profile, with only 2% of placebo patients experiencing adverse events leading to treatment discontinuation, compared to 0% in the 1.2 mg group and 1% in the 1.8 mg group [6] - Serious adverse events were reported in 3% of placebo patients, 2% in the 1.2 mg group, and 4% in the 1.8 mg group, with no serious adverse events deemed related to the treatment [6] Group 3: Future Outlook - The final readout of longer-term non-invasive tests and weight loss from the IMPACT trial is anticipated in the fourth quarter of 2025, which will provide further insights into the efficacy of pemvidutide [7][10] - The FDA has granted Fast Track designations to pemvidutide for the treatment of MASH and alcohol use disorder (AUD), indicating significant unmet medical needs in these areas [10]
Madrigal Presents New Data Demonstrating Rezdiffra® (resmetirom) Significantly Improved Multiple Noninvasive Imaging Tests and Biomarkers in Patients with Compensated MASH Cirrhosis
Globenewswire· 2025-11-10 13:00
Core Insights - Madrigal Pharmaceuticals announced positive two-year data from the Phase 3 MAESTRO-NAFLD-1 trial for Rezdiffra, targeting compensated MASH cirrhosis patients, a population with no approved therapies [1][3][4] - The data presented at the AASLD meeting highlighted significant improvements in liver stiffness, liver enzymes, and biomarkers in patients with advanced compensated MASH cirrhosis [2][6][8] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) [23] - Rezdiffra (resmetirom) is the first approved medication for treating MASH with moderate to advanced fibrosis in the U.S. and Europe [12][23] Clinical Trial Results - In the MAESTRO-NAFLD-1 trial, Rezdiffra showed statistically significant improvements in multiple imaging and biomarker parameters over two years in patients with compensated MASH cirrhosis [4][6] - Patients with platelet counts <100,000/µL demonstrated notable improvements, with a mean reduction in liver stiffness of -7.9 kPa [5][7] - Following two years of treatment, 39% of patients shifted to no/low CSPH risk scores, indicating a positive trend in disease management [7] Health-Related Quality of Life - Rezdiffra treatment resulted in significant and sustained improvements in health-related quality of life measures across various domains for both cirrhotic and non-cirrhotic patients [9][10] - Improvements were observed in fatigue, worry, emotional function, and abdominal symptoms, enhancing overall patient well-being [10][12] Safety and Tolerability - Rezdiffra was well-tolerated in the high-risk patient population, with a low rate of discontinuation due to adverse events [8][12] - No significant changes in bone mineral density or fracture risk were noted over the two-year treatment period [8] Future Directions - Madrigal is executing a fully enrolled Phase 3 outcomes study for Rezdiffra in compensated MASH cirrhosis patients, reinforcing its commitment to addressing this unmet medical need [3][12] - Continuous treatment with Rezdiffra is emphasized as necessary to maintain benefits and prevent disease progression, similar to management strategies for chronic diseases [12]
Madrigal Pharmaceuticals Reports Third-Quarter 2025 Financial Results and Provides Corporate Updates
Globenewswire· 2025-11-04 12:00
Core Insights - Madrigal Pharmaceuticals reports strong growth in third-quarter 2025, with net revenues of $287.3 million, a significant increase from $62.2 million in the same period last year, driven by the demand for Rezdiffra [4][5] - The company has over 29,500 patients currently on Rezdiffra therapy, with more than 10,000 healthcare providers prescribing it, indicating a successful launch and market penetration [2][5] - Madrigal is advancing its strategy to build a pipeline of complementary therapies, including a newly licensed oral GLP-1 therapy, to enhance treatment efficacy for metabolic dysfunction-associated steatohepatitis (MASH) [2][6] Financial Performance - Total revenues for Q3 2025 reached $287.3 million, compared to $62.2 million in Q3 2024, reflecting a substantial increase due to heightened demand for Rezdiffra [4][16] - Operating expenses for Q3 2025 were $401.2 million, up from $178.5 million in the prior year, primarily due to increased commercial activities and R&D expenses [12][16] - The net loss for Q3 2025 was $114.2 million, compared to a net loss of $107.0 million in Q3 2024, with a basic and diluted net loss per share of $5.08 [12][17] Corporate Developments - Madrigal launched Rezdiffra in Germany following European Commission approval, marking it as the first and only approved therapy for MASH in the EU [6][11] - The company has secured a new patent for Rezdiffra, providing protection until 2045, which supports its long-term strategy in the MASH market [6][12] - Madrigal is preparing for a significant presence at the upcoming AASLD Liver Meeting, with 15 abstracts accepted, showcasing its commitment to advancing research in liver diseases [6][11] Market Context - MASH is a serious liver disease that can lead to severe complications, including cirrhosis and liver failure, with a growing patient population in need of effective treatments [8][10] - The company aims to reach approximately 315,000 patients with moderate to advanced fibrosis in the U.S., highlighting the substantial market opportunity for Rezdiffra [9][10]