Latest news with #MadrigalPharmaceuticals
Yahoo
20-06-2025
- Business
- Yahoo
Madrigal Receives Positive CHMP Opinion for Resmetirom (Rezdiffra™) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis
Positive recommendation based on resmetirom's favorable profile including positive results from the pivotal Phase 3 MAESTRO-NASH trial European Commission decision expected in August 2025; if approved, resmetirom will be the first medication for people living with MASH in the E.U. CONSHOHOCKEN, Pa., June 20, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of resmetirom (Rezdiffra) for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. The European Commission decision is anticipated in August. Bill Sibold, Chief Executive Officer of Madrigal, stated, 'Madrigal is singularly focused on leading the fight against MASH globally. Resmetirom was the first medication to achieve fibrosis improvement and MASH resolution in a Phase 3 trial, the first medication to receive FDA-approval for MASH, and today's positive CHMP opinion represents another historic first for the global MASH community. MASH is the fastest-growing indication for liver transplantation in Europe, and we believe resmetirom has the potential to address the urgent unmet need for a foundational, liver-directed therapy to treat patients with this serious disease.' MASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Resmetirom is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. The CHMP opinion was based on resmetirom's favorable profile including the positive results from the pivotal Phase 3 MAESTRO-NASH trial, which achieved both fibrosis reduction and MASH resolution primary endpoints. Jörn M. Schattenberg, M.D., Professor of Medicine and Director of the Department of Medicine at the University Medical Center Homburg and University of the Saarland in Germany, stated, 'I'm encouraged by the CHMP's positive opinion recommending approval of resmetirom. After years of clinical research and growing appreciation of the burden of MASH on patients and health systems across Europe, we are finally on the cusp of having an approved therapy that targets the underlying disease. Importantly, resmetirom is already included in European clinical practice guidelines, which provide a framework for identifying and monitoring patients with noninvasive tests. If approved, I believe the medication has the potential to transform care for my patients with MASH.' The U.S. Food and Drug Administration (FDA) granted accelerated approval in March 2024 for Rezdiffra 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. 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 the leading cause of liver transplantation in women and the second leading cause of all liver transplantation in the U.S., and the fastest-growing indication for liver transplantation in Europe. 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. As MASH disease awareness improves and disease prevalence increases, the number of diagnosed patients with MASH with moderate to advanced fibrosis or compensated MASH cirrhosis (F2-F4c) 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 MASH cirrhosis treated with Rezdiffra versus placebo. 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 expected timing for a decision for marketing authorization by the European Commission and resmetirom's role as a potential foundational therapy for the treatment of MASH in Europe. 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. Investor ContactTina Ventura, IR@ Media ContactChristopher Frates, media@ while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Reuters
20-06-2025
- Health
- Reuters
EU medicines regulator grants conditional authorisation for Madrigal's liver disease drug
June 20 (Reuters) - The European Union's medicines regulator on Friday granted a conditional authorisation for Madrigal Pharmaceuticals' (MDGL.O), opens new tab drug for a type of fatty liver disease, paving the way to make it the first treatment available for the condition in the region. The drug, sold as Rezdiffra, was first approved in the United States in March last year. The disease known as non-alcoholic steatohepatitis (NASH), or more recently renamed as metabolic dysfunction-associated steatohepatitis (MASH), causes excess build up of fat in the liver, resulting in inflammation and fibrosis, or scarring, of the organ.
Yahoo
17-06-2025
- Business
- Yahoo
Madrigal Pharmaceuticals Announces Grants of Inducement Awards under Nasdaq Listing Rule 5635(c)(4)
CONSHOHOCKEN, Pa., June 17, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that it granted equity awards on June 15, 2025 to 36 new non-executive employees as equity inducement awards under the terms of Madrigal's 2023 Inducement Plan. The equity awards were approved by Madrigal's independent Compensation Committee in accordance with Nasdaq Listing Rule 5635(c)(4). The equity awards were granted as inducement material to employees' acceptance of employment with the company. The new employees received, in the aggregate, options to purchase 2,184 shares of Madrigal's common stock, and in the aggregate 21,125 time-based restricted stock units. All options granted have an exercise price of $295.57 per share, which is equal to the closing price of the company's common stock on the grant date, and vest as follows: (i) 25% of the option shares will vest on the first anniversary of the grant date and (ii) 6.25% of the option shares will vest on each quarterly anniversary following the first anniversary of the grant date. All restricted stock units granted vest in four equal installments on each of the first through fourth anniversaries of the grant date. The vesting of all awards described above shall be subject to each such employee's continued employment as of the applicable vesting date. About Madrigal Pharmaceuticals 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 Investor Contact Tina Ventura, IR@ Media ContactChristopher Frates, media@ in to access your portfolio
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. 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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
