Latest news with #MadrigalPharmaceuticals
Yahoo
13-05-2025
- Health
- Yahoo
Liver Fibrosis Market to Witness Rapid Growth at a CAGR of ~24% During the Forecast Period (2025-2034) with Emerging Treatment Options
DelveInsight's analysis forecasts liver fibrosis market growth due to the introduction of emerging therapies, expecting an increase in market size during the study period (2020–2034). This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. LAS VEGAS, May 13, 2025 /PRNewswire/ -- Liver fibrosis is a gradually worsening condition marked by excessive collagen buildup resulting from ongoing liver damage. This abnormal wound-healing response distorts the liver's structure, potentially progressing to cirrhosis, portal hypertension, and ultimately liver failure. Previously, liver steatosis was categorized as NAFLD and its more inflammatory subtype, NASH. However, to better reflect its metabolic roots, updated terminology such as MASLD and MASH has been introduced. These, along with other classifications like MASL, NASL, and MetALD, fall under the broader umbrella of Steatotic Liver Disease (SLD), offering improved diagnostic precision by emphasizing metabolic dysfunction. DelveInsight's assessment estimated around 8.3 million diagnosed prevalent cases of liver fibrosis across the seven major markets in 2024, with this figure expected to rise by 2034. Management of liver fibrosis involves a multifaceted approach due to its complex nature. Treatments include biological and pharmacological therapies, lifestyle and dietary changes, and surgical interventions, all aimed at halting disease progression and preserving liver function. Key therapeutic targets include fibrogenic pathways such as LOXL2 inhibition, antiviral treatments for viral causes, FXR agonists like obeticholic acid, and metabolic modulators to reduce inflammation and fibrotic buildup. Tailoring therapies to the underlying cause of fibrosis is crucial, underscoring the importance of personalized treatment strategies. To know more about liver fibrosis treatment options, visit @ New Treatment for Liver Fibrosis The approval of REZDIFFRA (resmetirom) in March 2024 represents a major advancement in the treatment of noncirrhotic MASH with moderate to advanced fibrosis. This groundbreaking therapy targets the root causes of MASH and brings renewed hope to patients affected by the condition. Clinical trials have shown impressive results, with REZDIFFRA significantly reducing inflammation and fibrosis, improving liver function, and enhancing patients' quality of life. Its approval marks a critical addition to the limited treatment options available, with the potential to lessen complications from progressive liver disease. Madrigal Pharmaceuticals aims to roll out REZDIFFRA across Europe starting with Germany in the second half of 2025, pending EMA approval for REZDIFFRA, making it the first authorized therapy for MASH-related liver fibrosis in the region. Furthermore, updated two-year data from the MAESTRO-NAFLD-1 trial, released in February 2025, indicate possible benefits for patients with compensated MASH cirrhosis, suggesting an expanded scope of clinical effectiveness. Madrigal's choice to commercialize REZDIFFRA independently in Europe presents both potential benefits and notable challenges. On one hand, it enables the company to retain full control and capture the entire value of the product. On the other, it faces the complexities of navigating Europe's fragmented healthcare landscape without a regional partner, which heightens the uncertainty around regulatory approvals and market uptake. The company expects a decision from the European Medicines Agency (EMA) by mid-2025, with launches rolling out on a country-by-country basis, starting in Germany in the second half of 2025. If approved, Madrigal Pharmaceutical's REZDIFFRA would become the first authorized treatment for MASH liver fibrosis in Europe. Learn more about the FDA-approved liver fibrosis drugs @ Drugs for Liver Fibrosis Treatment The treatment landscape is evolving rapidly, with various competitive threats emerging. Notable competitors include Inventiva Pharma's Lanifibranor (IVA337), Akero Therapeutics' Efruxifermin, Sagimet Biosciences' Denifanstat, 89bio's Pegozafermin, Novo Nordisk's WEGOVY (semaglutide), and others. In addition, several liver fibrosis drugs are currently being developed at various stages, including HU6 from Rivus Pharmaceuticals, LPCN 1144 from Lipocine, MN-001 from MediciNova, Icosabutate from NorthSea Therapeutics, Lixudebart (ALE.F02) from Alentis Therapeutics, PHIN-214 from PharmaIN, and FXR314 from Organovo. Competing liver fibrosis therapies in advanced clinical stages, including Inventiva's lanifibranor and Akero Therapeutics' efruxifermin, pose direct competition. Lanifibranor, in particular, offers a differentiated pan-PPAR agonist approach, potentially competing with REZDIFFRA's efficacy and safety profile. Discover which therapies are expected to grab major liver fibrosis market share @ Liver Fibrosis Market Report Efruxifermin (EFX) is Akero Therapeutics' primary candidate for MASH treatment. This Fc-FGF21 fusion protein is designed to replicate the natural activity of FGF21, a hormone that reduces cellular stress and helps regulate metabolism. EFX offers the convenience of once-weekly subcutaneous injections and is being developed for pre-cirrhotic MASH (F2-F3) and compensated cirrhosis due to MASH (F4). Early results suggest that EFX could potentially become a leading treatment for MASH if approved. In January 2025, Akero Therapeutics announced the completion of patient enrollment in the Phase III SYNCHRONY Real-World study for MASH or MASLD (F1-F4), with results expected in the first half of 2026. Pegozafermin (BIO89-100) is a compound that activates the fibroblast growth factor 21 (FGF21) receptor, a hormone involved in glucose and lipid metabolism. It has shown promise as a therapeutic for MASH. In January 2025, the company emphasized its strong position for the year, with ongoing Phase III trials in MASH. It expects to release topline data from its first Phase III trial in late 2025. The company is also conducting two Phase III trials—ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2-F3) patients and ENLIGHTEN-Cirrhosis for compensated cirrhotic MASH (F4) patients—both of which are actively enrolling global patients. BOS-580 (Efimosfermin Alfa) is a long-acting, once-monthly FGF21 analogue in development for MASH. This investigational fusion protein targets three FGF21 receptors for a balanced pharmacological effect. In November 2024, Boston Pharmaceuticals reported positive Phase II data for BOS-580 in F2/F3 MASH at AASLD 2024. The treatment showed significant improvement in fibrosis (≥1 stage) with no worsening of MASH after 24 weeks. Two-thirds of patients treated with BOS-580 achieved significant MASH resolution without worsening fibrosis, compared to placebo. The Phase II trial also showed reductions in liver injury markers, fibrosis, and improvements in metabolic health. BOS-580 has demonstrated low discontinuation rates in clinical trials, with gastrointestinal issues being the most common side effects. In June 2024, data presented at EASL Congress 2024 highlighted significant improvements in lipid profiles with BOS-580 treatment. Denifanstat, a selective fatty acid synthase (FASN) inhibitor, is advancing in Phase III trials for MASH, targeting De Novo Lipogenesis (DNL) to reduce palmitate production. In October 2024, Sagimet Biosciences concluded successful end-of-Phase II discussions with the US FDA, moving denifanstat into Phase III trials. The FASCINATE-3 trial focuses on non-cirrhotic MASH (F2/F3), and FASCINIT examines patients with suspected or confirmed MASLD/MASH. In February 2025, Sagimet announced lipidomic data from the Phase IIb FASCINATE-2 trial, focusing on triglycerides and LDL cholesterol in advanced fibrosis, which will be presented at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium. The US FDA granted denifanstat Breakthrough Therapy (BTD) and Fast Track Designation (FTD) for non-cirrhotic MASH with moderate to advanced fibrosis. Survodutide, a dual GLP-1/glucagon receptor agonist, is also in Phase III development for MASH and fibrosis, targeting key metabolic pathways. In October 2024, Boehringer Ingelheim initiated the LIVERAGE trials, including LIVERAGE for MASH with fibrosis and LIVERAGE-Cirrhosis for MASH with cirrhosis. The US FDA granted Survodutide BTD for non-cirrhotic MASH with fibrosis, while the European Medicines Agency (EMA) included it in its Priority Medicines (PRIME) scheme for NASH. Boehringer Ingelheim and Zealand Pharma received US FDA support, highlighting Survodutide's potential to address unmet needs in MASH treatment. Discover more about drugs for liver fibrosis in development @ Liver Fibrosis Clinical Trials The anticipated launch of these emerging therapies for liver fibrosis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the liver fibrosis treatment market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for liver fibrosis is expected to grow from USD 2.1 billion in 2024, with a significant CAGR of ~24% by 2034. This anticipated growth in the liver fibrosis market is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of liver fibrosis, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report, titled as Liver Fibrosis Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the liver fibrosis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The liver fibrosis market forecast report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Liver Fibrosis Diagnosed Prevalent Cases Liver Fibrosis Severity-specific Diagnosed Prevalent Cases Total Liver Fibrosis Diagnosed Prevalent Cases (≥F2 Stage) in MASH The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM liver fibrosis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this liver fibrosis market forecast report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the liver fibrosis treatment market. Also, stay abreast of the mitigating factors to improve your market position in the liver fibrosis therapeutic space. Related Reports Liver Fibrosis Pipeline Liver Fibrosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key liver fibrosis companies, including Galmed Research and Development, Ltd, AstraZeneca, Galectin Therapeutics, Resolution Therapeutics, AdAlta, Novo Nordisk A/S, Sagimet Biosciences Inc., Hepion Pharmaceuticals, Inc., Pliant Therapeutics, Inc., Inipharm, GAT Therapeutics, TiumBio, INVENT Pharmaceuticals, SFA Therapeutics, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc., among others. Metabolic Dysfunction-Associated Steatohepatitis Market Metabolic Dysfunction-Associated Steatohepatitis Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key MASH companies, including Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, among others. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP
Yahoo
13-05-2025
- Health
- Yahoo
Liver Fibrosis Market to Witness Rapid Growth at a CAGR of ~24% During the Forecast Period (2025-2034) with Emerging Treatment Options
DelveInsight's analysis forecasts liver fibrosis market growth due to the introduction of emerging therapies, expecting an increase in market size during the study period (2020–2034). This anticipated growth is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of the condition, which together foster higher demand for innovative and effective therapies. LAS VEGAS, May 13, 2025 /PRNewswire/ -- Liver fibrosis is a gradually worsening condition marked by excessive collagen buildup resulting from ongoing liver damage. This abnormal wound-healing response distorts the liver's structure, potentially progressing to cirrhosis, portal hypertension, and ultimately liver failure. Previously, liver steatosis was categorized as NAFLD and its more inflammatory subtype, NASH. However, to better reflect its metabolic roots, updated terminology such as MASLD and MASH has been introduced. These, along with other classifications like MASL, NASL, and MetALD, fall under the broader umbrella of Steatotic Liver Disease (SLD), offering improved diagnostic precision by emphasizing metabolic dysfunction. DelveInsight's assessment estimated around 8.3 million diagnosed prevalent cases of liver fibrosis across the seven major markets in 2024, with this figure expected to rise by 2034. Management of liver fibrosis involves a multifaceted approach due to its complex nature. Treatments include biological and pharmacological therapies, lifestyle and dietary changes, and surgical interventions, all aimed at halting disease progression and preserving liver function. Key therapeutic targets include fibrogenic pathways such as LOXL2 inhibition, antiviral treatments for viral causes, FXR agonists like obeticholic acid, and metabolic modulators to reduce inflammation and fibrotic buildup. Tailoring therapies to the underlying cause of fibrosis is crucial, underscoring the importance of personalized treatment strategies. To know more about liver fibrosis treatment options, visit @ New Treatment for Liver Fibrosis The approval of REZDIFFRA (resmetirom) in March 2024 represents a major advancement in the treatment of noncirrhotic MASH with moderate to advanced fibrosis. This groundbreaking therapy targets the root causes of MASH and brings renewed hope to patients affected by the condition. Clinical trials have shown impressive results, with REZDIFFRA significantly reducing inflammation and fibrosis, improving liver function, and enhancing patients' quality of life. Its approval marks a critical addition to the limited treatment options available, with the potential to lessen complications from progressive liver disease. Madrigal Pharmaceuticals aims to roll out REZDIFFRA across Europe starting with Germany in the second half of 2025, pending EMA approval for REZDIFFRA, making it the first authorized therapy for MASH-related liver fibrosis in the region. Furthermore, updated two-year data from the MAESTRO-NAFLD-1 trial, released in February 2025, indicate possible benefits for patients with compensated MASH cirrhosis, suggesting an expanded scope of clinical effectiveness. Madrigal's choice to commercialize REZDIFFRA independently in Europe presents both potential benefits and notable challenges. On one hand, it enables the company to retain full control and capture the entire value of the product. On the other, it faces the complexities of navigating Europe's fragmented healthcare landscape without a regional partner, which heightens the uncertainty around regulatory approvals and market uptake. The company expects a decision from the European Medicines Agency (EMA) by mid-2025, with launches rolling out on a country-by-country basis, starting in Germany in the second half of 2025. If approved, Madrigal Pharmaceutical's REZDIFFRA would become the first authorized treatment for MASH liver fibrosis in Europe. Learn more about the FDA-approved liver fibrosis drugs @ Drugs for Liver Fibrosis Treatment The treatment landscape is evolving rapidly, with various competitive threats emerging. Notable competitors include Inventiva Pharma's Lanifibranor (IVA337), Akero Therapeutics' Efruxifermin, Sagimet Biosciences' Denifanstat, 89bio's Pegozafermin, Novo Nordisk's WEGOVY (semaglutide), and others. In addition, several liver fibrosis drugs are currently being developed at various stages, including HU6 from Rivus Pharmaceuticals, LPCN 1144 from Lipocine, MN-001 from MediciNova, Icosabutate from NorthSea Therapeutics, Lixudebart (ALE.F02) from Alentis Therapeutics, PHIN-214 from PharmaIN, and FXR314 from Organovo. Competing liver fibrosis therapies in advanced clinical stages, including Inventiva's lanifibranor and Akero Therapeutics' efruxifermin, pose direct competition. Lanifibranor, in particular, offers a differentiated pan-PPAR agonist approach, potentially competing with REZDIFFRA's efficacy and safety profile. Discover which therapies are expected to grab major liver fibrosis market share @ Liver Fibrosis Market Report Efruxifermin (EFX) is Akero Therapeutics' primary candidate for MASH treatment. This Fc-FGF21 fusion protein is designed to replicate the natural activity of FGF21, a hormone that reduces cellular stress and helps regulate metabolism. EFX offers the convenience of once-weekly subcutaneous injections and is being developed for pre-cirrhotic MASH (F2-F3) and compensated cirrhosis due to MASH (F4). Early results suggest that EFX could potentially become a leading treatment for MASH if approved. In January 2025, Akero Therapeutics announced the completion of patient enrollment in the Phase III SYNCHRONY Real-World study for MASH or MASLD (F1-F4), with results expected in the first half of 2026. Pegozafermin (BIO89-100) is a compound that activates the fibroblast growth factor 21 (FGF21) receptor, a hormone involved in glucose and lipid metabolism. It has shown promise as a therapeutic for MASH. In January 2025, the company emphasized its strong position for the year, with ongoing Phase III trials in MASH. It expects to release topline data from its first Phase III trial in late 2025. The company is also conducting two Phase III trials—ENLIGHTEN-Fibrosis for non-cirrhotic MASH (F2-F3) patients and ENLIGHTEN-Cirrhosis for compensated cirrhotic MASH (F4) patients—both of which are actively enrolling global patients. BOS-580 (Efimosfermin Alfa) is a long-acting, once-monthly FGF21 analogue in development for MASH. This investigational fusion protein targets three FGF21 receptors for a balanced pharmacological effect. In November 2024, Boston Pharmaceuticals reported positive Phase II data for BOS-580 in F2/F3 MASH at AASLD 2024. The treatment showed significant improvement in fibrosis (≥1 stage) with no worsening of MASH after 24 weeks. Two-thirds of patients treated with BOS-580 achieved significant MASH resolution without worsening fibrosis, compared to placebo. The Phase II trial also showed reductions in liver injury markers, fibrosis, and improvements in metabolic health. BOS-580 has demonstrated low discontinuation rates in clinical trials, with gastrointestinal issues being the most common side effects. In June 2024, data presented at EASL Congress 2024 highlighted significant improvements in lipid profiles with BOS-580 treatment. Denifanstat, a selective fatty acid synthase (FASN) inhibitor, is advancing in Phase III trials for MASH, targeting De Novo Lipogenesis (DNL) to reduce palmitate production. In October 2024, Sagimet Biosciences concluded successful end-of-Phase II discussions with the US FDA, moving denifanstat into Phase III trials. The FASCINATE-3 trial focuses on non-cirrhotic MASH (F2/F3), and FASCINIT examines patients with suspected or confirmed MASLD/MASH. In February 2025, Sagimet announced lipidomic data from the Phase IIb FASCINATE-2 trial, focusing on triglycerides and LDL cholesterol in advanced fibrosis, which will be presented at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium. The US FDA granted denifanstat Breakthrough Therapy (BTD) and Fast Track Designation (FTD) for non-cirrhotic MASH with moderate to advanced fibrosis. Survodutide, a dual GLP-1/glucagon receptor agonist, is also in Phase III development for MASH and fibrosis, targeting key metabolic pathways. In October 2024, Boehringer Ingelheim initiated the LIVERAGE trials, including LIVERAGE for MASH with fibrosis and LIVERAGE-Cirrhosis for MASH with cirrhosis. The US FDA granted Survodutide BTD for non-cirrhotic MASH with fibrosis, while the European Medicines Agency (EMA) included it in its Priority Medicines (PRIME) scheme for NASH. Boehringer Ingelheim and Zealand Pharma received US FDA support, highlighting Survodutide's potential to address unmet needs in MASH treatment. Discover more about drugs for liver fibrosis in development @ Liver Fibrosis Clinical Trials The anticipated launch of these emerging therapies for liver fibrosis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the liver fibrosis treatment market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for liver fibrosis is expected to grow from USD 2.1 billion in 2024, with a significant CAGR of ~24% by 2034. This anticipated growth in the liver fibrosis market is driven by advancements in treatment options, greater healthcare access, and a rising prevalence of liver fibrosis, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report, titled as Liver Fibrosis Market Insight, Epidemiology, and Market Forecast – 2034, will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the liver fibrosis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The liver fibrosis market forecast report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Liver Fibrosis Diagnosed Prevalent Cases Liver Fibrosis Severity-specific Diagnosed Prevalent Cases Total Liver Fibrosis Diagnosed Prevalent Cases (≥F2 Stage) in MASH The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM liver fibrosis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this liver fibrosis market forecast report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the liver fibrosis treatment market. Also, stay abreast of the mitigating factors to improve your market position in the liver fibrosis therapeutic space. Related Reports Liver Fibrosis Pipeline Liver Fibrosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key liver fibrosis companies, including Galmed Research and Development, Ltd, AstraZeneca, Galectin Therapeutics, Resolution Therapeutics, AdAlta, Novo Nordisk A/S, Sagimet Biosciences Inc., Hepion Pharmaceuticals, Inc., Pliant Therapeutics, Inc., Inipharm, GAT Therapeutics, TiumBio, INVENT Pharmaceuticals, SFA Therapeutics, among others. Non-Alcoholic Fatty Liver Disease Market Non-Alcoholic Fatty Liver Disease Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key NAFLD companies, including MediciNova, Eli Lilly and Company, AstraZeneca, Inventiva Pharma, Oasis Pharmaceuticals, LLC, Madrigal Pharmaceuticals, Inc., BioMarin Pharmaceutical, GlaxoSmithKline, Zydus Therapeutics Inc., Akero Therapeutics, Inc, Pfizer, Boehringer Ingelheim, Neuraly, Inc., Merck Sharp & Dohme LLC, Rivus Pharmaceuticals, Inc., Hepion Pharmaceuticals, Inc., among others. Metabolic Dysfunction-Associated Steatohepatitis Market Metabolic Dysfunction-Associated Steatohepatitis Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key MASH companies, including Inventiva Pharma, Novo Nordisk A/S, Cirius Therapeutics, Akero Therapeutics, 89bio, Boehringer Ingelheim, Zealand Pharma, Galectin Therapeutics, Lipocine, Viking Therapeutics, Eli Lilly and Company, Boston Pharmaceuticals, Pfizer, HighTide Biopharma, CytoDyn, Merck & Co., Hanmi Pharmaceutical, Hepagene (Shanghai), Hepion Pharmaceuticals, Enyo Pharmaceuticals, Gilead Sciences, Poxel SA, Zydus Therapeutics, Sagimet Biosciences, Ionis Pharmaceuticals, Corcept Therapeutics, among others. Nonalcoholic Steatohepatitis Pipeline Nonalcoholic Steatohepatitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonalcoholic steatohepatitis companies, including Madrigal Pharmaceuticals, Intercept Pharmaceuticals, Cirius Therapeutics, Novo Nordisk, Inventiva, Galmed Pharmaceuticals, AstraZeneca, Galectin Therapeutics, Viking Therapeutics, Eli Lilly and Company, Terns Pharmaceuticals, Sinew Pharma, 89bio, Inc., Eccogene, Novartis Pharmaceuticals, Poxel SA, AngioLab, Pfizer, Arrowhead Pharma, LG Chem, Redx Pharma, Lipocine, Inc., CytoDyn, Inc., Alnylam Pharmaceuticals, Inc., Chemomab Therapeutics, NuSirt Biopharma, HK inno. N, Aligos Therapeutics, Altimmune, Inc., Kowa Pharmaceutical, Ionis Pharmaceuticals, NorthSea Therapeutics, Rivus Pharmaceuticals, Hanmi Pharmaceutical, Hepagene Therapeutics, HighTide Biopharma, Akero Therapeutics, Merck Sharp & Dohme LLC, Cascade Pharmaceuticals, Hepion Pharmaceuticals, Chipscreen Biosciences, Boston Pharmaceuticals, Bristol-Myers Squibb, Sunshine Lake Pharma, GSK plc., Future Medicine, Gilead Sciences, ENYO Pharma, Histogen, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact Us Shruti Thakur info@ +14699457679 Logo: View original content: SOURCE DelveInsight Business Research, LLP
Yahoo
13-05-2025
- Business
- Yahoo
2 Monster Stocks in the Making to Buy Now and Hold for 10 Years
Viking Therapeutics has a promising pipeline candidate in the fast-growing therapeutic area of weight loss. Madrigal Pharmaceuticals markets the only approved therapy for a disease whose prevalence is growing. 10 stocks we like better than Viking Therapeutics › Investing in promising companies before their stock prices soar is an excellent recipe for earning life-changing returns. However, with hundreds of companies vying for investors' attention, separating the wheat from the chaff can be challenging. Recognizing those corporations with long-term market-beating potential -- especially before they are well-established -- isn't easy, but let's give it a shot anyway. Consider two mid-cap biotechs: Viking Therapeutics (NASDAQ: VKTX) and Madrigal Pharmaceuticals (NASDAQ: MDGL). These two drugmakers could grow in prominence in the next decade and deliver superior returns. Viking Therapeutics became famous in the biotech world last year after announcing positive phase 2 results for VK2735, an investigational GLP-1 weight loss candidate. The stock has not performed well since, which we can attribute to several factors. First, longtime investors took the opportunity to cash in on its big jump. Second, Viking hasn't had any clinical update as significant as that since. Third, like most other corporations, the drugmaker is suffering from marketwide issues. However, the bullish case for Viking is straightforward. The company could develop successful medicines in areas with unmet or growing needs. VK2735 has produced phase 2 data that rivals almost any other anti-obesity candidate outside those being developed by the leaders in the field, Eli Lilly and Novo Nordisk. Then there's VK2809, a promising candidate for metabolic dysfunction-associated steatohepatitis (MASH). Because obesity is a major risk factor for MASH, there's a significant need for therapies to address the condition. There is only one medicine approved by the U.S. Food and Drug Administration (FDA) for this disease, so there's room for others. VK2809, like VK2735, should make more progress this year. Elsewhere, Viking is developing VK0214 to treat X-linked adrenoleukodystrophy (X-ALD), a rare genetic nervous-system disorder. There are ways to manage X-ALD symptoms, but there is no disease-specific FDA-approved treatment. VK0214 has earned the orphan drug designation from the agency, which is reserved for therapies in development that have shown promising clinical evidence in treating rare diseases. So Viking's pipeline looks promising, and we haven't even mentioned the company's oral version of VK2735. True, the stock is somewhat risky, as are all clinical-stage biotech companies. However, if enough things go Viking's way, it could generate monster returns in the next decade as it earns approval for key products and starts generating strong revenue. In my view, initiating a small position in the stock is worth it. The only FDA-approved medicine for MASH, Rezdiffra, belongs to Madrigal Pharmaceuticals. It earned this honor early last year, although the medicine is under accelerated approval; that means it will have to prove efficacy once and for all in confirmatory studies, or it could be taken off the market. In the meantime, the drug is performing well. In the first quarter, its sales came in at $137.3 million, ahead of consensus analyst estimates; the medicine has made it a habit to top Wall Street's projections. It also speaks volumes about Madrigal. Plenty of drugmaking giants are looking to develop breakthrough therapies in this field. So far, only Madrigal has succeeded. Though another company will eventually challenge Madrigal, the future still looks bright. The biotech is already treating 17,000 patients with Rezdiffra, but that's still just about 5% of the 315,000 the company is targeting. Also, its crown jewel is approved for MASH patients with moderate to advanced liver fibrosis (scarring). Madrigal will seek label expansions in the most advanced form of scarring, cirrhosis. The biotech estimates that this indication could double its target market. And that's before we consider the fact that the number of people with MASH is increasing and, according to some estimates, will continue to do so well beyond the next 10 with potential competition on the way, Madrigal Pharmaceuticals has a massive addressable market. That, together with its first-mover advantage and potential clinical progress for Rezdiffra, could allow it to generate superior returns in the next 10 years. The company could be on the way to establishing itself as a biotech leader. Before you buy stock in Viking Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Viking Therapeutics wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $598,613!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $753,878!* Now, it's worth noting Stock Advisor's total average return is 922% — a market-crushing outperformance compared to 169% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 12, 2025 Prosper Junior Bakiny has positions in Eli Lilly, Novo Nordisk, and Viking Therapeutics. The Motley Fool recommends Novo Nordisk and Viking Therapeutics. The Motley Fool has a disclosure policy. 2 Monster Stocks in the Making to Buy Now and Hold for 10 Years was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Insider
11-05-2025
- Health
- Business Insider
Madrigal announces two-year results from Phase 3 MAESTRO-NAFLD-1 trial
Madrigal Pharmaceuticals (MDGL) announced positive two-year results from the open-label compensated MASH cirrhosis arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients in the study achieved significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension, CSPH. Among patients with CSPH at baseline, 65% moved into lower risk categories by year two. Among patients with probable CSPH at baseline, 57% moved into the no/low CSPH category as compared to 14% who moved into the CSPH category by year two. Improvement in CSPH risk was statistically significant compared to baseline. Similar shifts to lower risk categories were observed in an analysis using a more stringent modified Baveno criteria that incorporates magnetic resonance elastography and the Enhanced Liver Fibrosis test as additional evidence for CSPH risk. Safety data were consistent with previous studies and Rezdiffra was well-tolerated with a low rate of discontinuation due to adverse events. The most common adverse events were diarrhea, COVID-19 and nausea. There were two deaths unrelated to Rezdiffra. Protect Your Portfolio Against Market Uncertainty
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10-05-2025
- Business
- Yahoo
Madrigal Announces New Clinical Data Demonstrating Rezdiffra™ (resmetirom) Significantly Improved Multiple Noninvasive Tests and Portal Hypertension Risk in Patients with Compensated MASH Cirrhosis
Late-breaking results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial presented at the EASL Congress 65% of patients with clinically significant portal hypertension (CSPH) at baseline moved into lower risk categories by year two Patients achieved a mean 6.7 kPa reduction in liver stiffness, which was statistically significant compared to baseline CONSHOHOCKEN, Pa., May 10, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced positive two-year results from the open-label compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial of Rezdiffra. Patients (n=122) in the study achieved significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension (CSPH). 'Rezdiffra demonstrated broad, sustained efficacy across multiple noninvasive parameters at two years of treatment. A high, statistically significant percentage of patients with CSPH or probable CSPH at baseline shifted to lower risk categories,' said Naim Alkhouri, M.D., Chief Academic Officer at Summit Clinical Research and the Director of the Steatotic Liver Disease Program at the Clinical Research Institute of Ohio. 'A larger placebo-controlled study will be needed to confirm Rezdiffra's benefit in F4c, but the totality of data in this high-risk population of patients on the cusp of progressing to liver decompensation is highly encouraging as we await results from the ongoing Phase 3 MAESTRO-NASH OUTCOMES trial of Rezdiffra.' CSPH is a major consequence of cirrhosis and is responsible for its most severe complications, including ascites, variceal bleeding and hepatic encephalopathy. Patients with MASH who progress to cirrhosis face a 42 times higher risk of liver-related mortality. MAESTRO-NAFLD-1 included an open-label active treatment arm of patients with compensated MASH cirrhosis. After one year, patients were given the option to enroll in an open-label extension trial; 122 patients enrolled and 113 completed two years of treatment. At baseline, 35% of patients met Baveno criteria for CSPH, 14% for probable CSPH and 51% for no/low CSPH. The Baveno criteria use a combination of vibration-controlled transient elastography (VCTE) and platelet count to assess CSPH risk. Among patients with CSPH at baseline, 65% moved into lower risk categories by year two (42% to no/low CSPH and 23% to probable CSPH). Among patients with probable CSPH at baseline, 57% moved into the no/low CSPH category as compared to 14% who moved into the CSPH category by year two. Improvement in CSPH risk was statistically significant compared to baseline. Similar shifts to lower risk categories were observed in an analysis using a more stringent modified Baveno criteria that incorporates magnetic resonance elastography (MRE) and the Enhanced Liver Fibrosis (ELF) test as additional evidence for CSPH risk. As previously reported, patients achieved a mean 6.7 kPa reduction in liver stiffness at two years, which was statistically significant compared to baseline. In a responder analysis examining ≥25% improvement or worsening of liver stiffness, 51% of patients achieved improvement. An improvement of this magnitude has been associated with reduced progression to end-stage liver disease.1 Rezdiffra helped 35% of patients achieve liver stiffness measurements consistent with F3 fibrosis, suggesting reversal of cirrhosis. Safety data were consistent with previous studies and Rezdiffra was well-tolerated with a low rate of discontinuation due to adverse events. The most common adverse events were diarrhea, COVID-19 and nausea. There were two deaths unrelated to Rezdiffra. 'Lower thyroid-hormone receptor-beta (THR-β) activity in the liver is predictive of hepatic decompensation2 in patients with MASH, so there is a strong mechanistic rationale supporting the potential of Rezdiffra, a THR-β agonist, to improve outcomes in patients with compensated MASH cirrhosis,' said David Soergel, M.D., Chief Medical Officer of Madrigal. 'These two-year open-label data from MAESTRO-NAFLD-1 add important clinical evidence that supports our confidence in the ongoing, fully enrolled Phase 3 outcomes trial of Rezdiffra in compensated MASH cirrhosis.' Investor Webcast to Review New F4c DataAt 8 a.m. EDT May 13, 2025, Madrigal will host a webcast to review the detailed two-year data from the compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial. To access the webcast, please visit the investor relations section of the Madrigal website or click here to register. About MASHMetabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), is a serious liver disease that can progress to cirrhosis, liver failure, liver cancer, need for liver transplantation, and premature mortality. MASH is expected to become the leading cause of liver transplantation in the U.S. and is already the leading cause of liver transplantation among women. Once patients progress to MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically: these patients have a 10-17 times higher risk of liver-related mortality as compared to patients without fibrosis. Those who progress to cirrhosis face a 42 times higher risk of liver-related mortality, underscoring the need to treat MASH before complications of cirrhosis develop. MASH is also an independent driver of cardiovascular disease, the leading cause of mortality for patients. An estimated 1.5 million patients have been diagnosed with MASH in the U.S., and Madrigal is focused on reaching approximately 315,000 patients with moderate to advanced fibrosis who are under the care of liver specialists. As MASH disease awareness improves and disease prevalence increases, the number of diagnosed patients with MASH with moderate to advanced fibrosis is expected to grow. About RezdiffraRezdiffra is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. It is the first approved medication for the treatment of MASH in the U.S. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and MASH resolution primary endpoints, and 91% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of liver stiffness. In the U.S., Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Rezdiffra is not approved in Europe for the treatment of patients with MASH with moderate to advanced liver fibrosis and not approved in any geography for the treatment of patients with cirrhosis. The ongoing, fully enrolled MAESTRO-NASH OUTCOMES trial is evaluating progression to liver decompensation events in patients with compensated NASH cirrhosis treated with Rezdiffra versus placebo. A positive outcome is expected to support the full approval of Rezdiffra for noncirrhotic MASH and expand the eligible patient population for Rezdiffra with an additional indication in patients with compensated MASH cirrhosis. What is Rezdiffra?Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. It is not known if Rezdiffra is safe and effective in children (under 18 years old).This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than NASH. have gallbladder problems or have been told you have gallbladder problems, including gallstones. are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works. Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines. Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra?Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen). gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting. The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or You may also report side effects to Madrigal at 1-800-905-0324. Please see the full Prescribing Information, including Patient Information, for Rezdiffra. About Madrigal Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with high unmet medical need. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by the FDA for the treatment of MASH with moderate to advanced fibrosis (consistent with stages F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (consistent with stage F4c). For more information, visit Forward-Looking StatementsThis press release includes 'forward-looking statements' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the potential benefit of Rezdiffra in patients with compensated MASH cirrhosis. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that did not have commercial experience prior to 2024; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of Madrigal's clinical trials, including, but not limited to Madrigal's ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal's trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra's (resmetirom's) mechanism of action; market demand for and acceptance of Rezdiffra; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financing on acceptable terms; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive trials; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal's submissions filed with the U.S. Securities and Exchange Commission('SEC'), for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part I, Item 1A of its Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on February 26, 2025, and as updated from time to time by Madrigal's other filings with the SEC. 1. Lin H, Lee HW, Yip TC, et al. Vibration-Controlled Transient Elastography Scores to Predict Liver-Related Events in Steatotic Liver Disease. JAMA. 2024;331(15):1287–1297.2. Kendall TJ, Jimenez-Ramos M, Turner F, et al. An integrated gene-to-outcome multimodal database for metabolic dysfunction-associated steatotic liver disease. Nat Med. 2023 Nov;29(11):2939-2953. Investor ContactTina Ventura, IR@ Media ContactChristopher Frates, media@ in to access your portfolio
