Madrigal Pharmaceuticals Inc (MDGL)

Madrigal’s (MDGL) MASH Strategy Reiinforced By Rezdiffra Sales Growth and Pipeline ExpansionMay 6, 2026 10:46 AM
IH Market News Madrigal Pharmaceuticals reported strong first-quarter revenue growth driven by Rezdiffra adoption while expanding its MASH pipeline through new siRNA licensing and development agreements. Key Investor Takeaways Madrigal Pharmaceuticals (NASDAQ:MDGL) reported first-quarter 2026 revenue growth of 127% as Rezdiffra achieved blockbuster status on a trailing 12-month basis. The company expanded its MASH pipeline with a newly licensed siRNA asset targeting the PNPLA3 mutation and six additional preclinical siRNA programs. Rezdiffra adoption continued to grow, supported by physician uptake and increasing patient demand in the MASH market. Operating expenses rose significantly due to pipeline expansion costs and continued commercial investment. Investors may focus on long-term market opportunity in MASH, pipeline diversification, and the company’s ability to manage spending while scaling commercialization. Why MDGL Stock Is in Focus Madrigal Pharmaceuticals (NASDAQ:MDGL) reported first-quarter 2026 financial results highlighted by strong Rezdiffra sales growth and expansion of its MASH-focused pipeline.Net revenue for the quarter reached $311.3 million, up 127% from $137.3 million during the same period last year.The company said Rezdiffra achieved blockbuster status on a trailing 12-month net sales basis, driven by broad physician adoption and rising patient demand.CEO Bill Sibold stated that the diagnosed MASH patient population has expanded nearly 50% over the last two years to approximately 460,000 patients.“2026 is off to a terrific start,” Sibold said.“Rezdiffra has achieved blockbuster status on a trailing-12-month net sales basis, reflecting broad physician adoption and high patient demand.”Madrigal also announced a licensing agreement with Arrowhead Pharmaceuticals for global rights to ARO-PNPLA3, a clinical-stage siRNA candidate targeting a genetic mutation linked to advanced liver fibrosis in MASH patients.According to the company, Phase 1 data for the asset showed up to a 46% reduction in liver fat after a single dose in certain genetically defined patients.In addition, Madrigal disclosed that it expanded its pipeline earlier this year with six preclinical siRNA programs focused on next-generation MASH therapies.The company plans to present eight abstracts at the upcoming EASL Congress, including data tied to cardiovascular risk markers and real-world Rezdiffra outcomes. Higher Spending Reflects Commercial and Pipeline Expansion Operating expenses increased to $404.1 million during the quarter, compared with $216.6 million in the prior-year period.The increase included $54.3 million in one-time business development expenses tied to pipeline expansion activities.Research and development expenses rose to $108.7 million, while SG&A expenses increased to $268.5 million due to expanded commercial investments, including endocrinology field force growth and direct-to-consumer marketing efforts.Madrigal reported a quarterly net loss of $94.4 million, compared with a loss of $73.2 million a year earlier.Cash, cash equivalents, restricted cash, and marketable securities totaled $817.9 million as of March 31, 2026. Why This Matters for Investors The update reinforces Madrigal’s position as an early commercial leader in the rapidly expanding MASH treatment market following Rezdiffra’s launch.Strong revenue growth and physician adoption may support the company’s long-term commercialization narrative, especially given the limited number of approved therapies currently available for MASH patients with fibrosis.The expansion into genetically targeted siRNA therapies also suggests Madrigal is attempting to build a broader franchise that could support combination treatment approaches across different patient populations.At the same time, rising operating expenses and continued net losses may remain an area of investor focus as the company scales commercial operations and advances pipeline development.The company’s long-term growth outlook may also depend on continued reimbursement expansion, physician adoption trends, competitive dynamics, and future clinical data. What To Watch Next Investors may monitor: Continued prescription and revenue growth for Rezdiffra Progress of ARO-PNPLA3 and other siRNA pipeline programs Data presentations at the upcoming EASL Congress Results from the ongoing Phase 3 trial in compensated MASH cirrhosis Commercial spending trends and cash utilization Expansion of the diagnosed MASH patient population Madrigal Pharmaceuticals stock price Original: Madrigal’s (MDGL) MASH Strategy Reiinforced By Rezdiffra Sales Growth and Pipeline Expansion

The $578 Billion Regenerative Medicine Market Has a Manufacturing Problem. One Company Just Solved the First StepMarch 31, 2026 8:49 PM
PR Newswire (US)

Issued on behalf of Avaí Bio, Inc.USANewsGroup.comVANCOUVER, BC, March 31, 2026 /PRNewswire/ -- The FDA has approved more than 40 cell and gene therapy products. The regenerative medicine market is projected to reach $578 billion by 2033. Cell therapy alone surpassed $8.2 billion this year. And yet the central challenge of the entire sector remains unresolved: how do you manufacture living therapeutics at scale, consistently, and affordably?







Every cell therapy company confronts the same bottleneck. You can discover a transformative biological mechanism in a lab. You can prove it works in a trial. But the moment you need to produce it reliably for thousands or millions of patients, you run into the manufacturing wall. The cells degrade. The immune system rejects them. The supply chain breaks. The companies that solve manufacturing are the ones that will capture the value in this market.That manufacturing challenge is driving some of the most important milestones in the sector right now. Prime Medicine (NASDAQ: PRME) is developing prime editing — a next-generation gene editing platform that rewrites DNA without cutting both strands, reducing the off-target risks that have haunted earlier CRISPR approaches. The technology promises more precise manufacturing of gene-corrected cells at scale. Madrigal Pharmaceuticals (NASDAQ: MDGL) presented two-year data showing its therapy Rezdiffra significantly improved liver stiffness and fibrosis biomarkers in patients with compensated MASH cirrhosis, demonstrating that manufactured biologics can deliver sustained, measurable reversal of chronic organ damage.Iovance Biotherapeutics (NASDAQ: IOVA) received FDA approval for Amtagvi, a tumor-infiltrating lymphocyte therapy for advanced melanoma — the first approved TIL therapy, which requires extracting and expanding a patient's own immune cells in a centralized manufacturing facility. It's a landmark approval, but it also highlights the manufacturing complexity: each treatment is custom-made from the patient's own tumor tissue. Denali Therapeutics (NASDAQ: DNLI) is advancing tividenofusp alfa for Hunter syndrome, with a PDUFA target date of April 2026 and Fast Track, Breakthrough Therapy, and Priority Medicines designations — a therapy that requires precise protein engineering and scaled biomanufacturing to cross the blood-brain barrier.Each of these companies is grappling with a version of the same problem: how do you turn a biological discovery into a manufactured product? The answer, increasingly, starts with a Master Cell Bank.Avaí Bio (OTCQB: AVAI) recently announced the initiation of manufacturing a Master Cell Bank of genetically modified cells that overexpress the a-Klotho protein, working alongside joint venture partner Austrianova through their shared entity, Klothonova. A Master Cell Bank is the GMP-compliant, fully characterized starting material for all downstream production — the foundation from which all working cell banks and final therapeutic products are derived. Without it, there is no path to commercial scale.What makes Avaí Bio's approach distinctive is the delivery mechanism. Austrianova's Cell-in-a-Box® encapsulation technology protects the therapeutic cells inside a biocompatible shell, allowing them to continuously secrete a-Klotho without triggering immune rejection. This eliminates the manufacturing and logistical burden of patient-specific autologous therapies — the cells are manufactured once and delivered as an off-the-shelf product. The technology is backed by over 50 peer-reviewed publications and decades of clinical development.Prof. Walter H. Gunzburg, Chairman of Austrianova, said: "MCBs are a prerequisite for the production of Cell-in-a-Box® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards."Avaí Bio's dual-program approach targets both the Klothonova a-Klotho anti-aging platform and the Insulinova diabetes program. Peer-reviewed research links a-Klotho to reduced risk of Alzheimer's, cardiovascular disease, and certain cancers, with natural levels declining approximately 50% after age 40. The addressable markets span Alzheimer's ($32.8 billion by 2033), cardiovascular disease (the world's leading cause of death), and kidney disease (850 million affected globally).The regenerative medicine market is heading toward $578 billion. The companies that will capture the lion's share of that value are the ones that can manufacture living therapeutics reliably and at scale. Avaí Bio (OTCQB: AVAI) just took the foundational manufacturing step — and it did so with a delivery platform that turns cell therapy from a custom procedure into a scalable product.For more information on Avaí Bio (OTCQB: AVAI) and its Klothonova and Insulinova programs, visit USANewsGroup.comRead this and more news for Avaí Bio at: USANewsGroup.comArticle Source: https://usanewsgroup.com/avai-profile/ CONTACT:USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avaí Bio, Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Avaí Bio, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avaí Bio, Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avaí Bio, Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:1. Straits Research, Global Cell Therapy Market 2026 — https://straitsresearch.com/report/cell-therapy-market 2. Precedence Research, Cell and Gene Therapy Market Forecast — https://www.precedenceresearch.com/cell-and-gene-therapy-market 3. Grand View Research, CAR T-Cell Therapy Market — https://www.grandviewresearch.com/industry-analysis/car-t-cell-therapy-market-report 4. Astute Analytica, Regenerative Medicine Market 2025–2033 — https://www.globenewswire.com/news-release/2026/01/27/3226653/0/en/Regenerative-Medicine-Market-Review-2020-2024-and-Forecast-2025-2033-A-578-29-Bn-Opportunity-Says-Astute-Analytica.htmlLogo - https://mma.prnewswire.com/media/2838876/5894781/USA_News_Group_Logo.jpg



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Original: The $578 Billion Regenerative Medicine Market Has a Manufacturing Problem. One Company Just Solved the First Step

Advanced Cell-based Therapy Booming the Success for Healthcare SectorMarch 24, 2026 10:00 AM
PR Newswire (US)

Issued on behalf of Avaí Bio, Inc.VANCOUVER, BC, March 24, 2026 /PRNewswire/ -- USANewsGroup.com — The FDA has approved more than 40 cell and gene therapy products. The regenerative medicine market is projected to reach $578 billion by 2033. Cell therapy alone surpassed $8.2 billion this year. But every cell-based therapy — no matter how revolutionary the science — begins with the same foundational requirement: a reliable, standardized bank of cells to work from.
Without that cellular starting material, there is no consistency, no scalability, and no path from laboratory discovery to therapeutic development. A Master Cell Bank (MCB) is the process of taking a single genetically engineered cell and cloning it into tens of millions of identical copies under GMP-compliant conditions. It's the foundational infrastructure that ensures every subsequent step in therapy development works from the same characterized, quality-controlled source. It's not the therapy itself — it's the prerequisite that makes therapy development possible.That distinction matters, because the companies advancing cell therapies right now are each navigating their own version of the journey from cellular science to clinical reality. Prime Medicine (NASDAQ: PRME) is developing prime editing — a next-generation gene editing platform that rewrites DNA without cutting both strands, reducing off-target risks that have haunted earlier CRISPR approaches. The precision is remarkable, but the path from edited cell to approved therapy is measured in years of development, trials, and manufacturing scale-up. Madrigal Pharmaceuticals (NASDAQ: MDGL) presented two-year data showing its therapy, Rezdiffra, significantly improved liver stiffness and fibrosis biomarkers in patients with compensated MASH cirrhosis — demonstrating that biological interventions can deliver sustained, measurable reversal of chronic organ damage.Iovance Biotherapeutics (NASDAQ: IOVA) received FDA approval for Amtagvi, the first approved tumor-infiltrating lymphocyte therapy for advanced melanoma. It's a landmark, but each treatment must be custom-manufactured from the individual patient's own tumor tissue — underscoring how critical scalable cellular infrastructure is to the future of the field. Denali Therapeutics (NASDAQ: DNLI) is advancing tividenofusp alfa for Hunter syndrome, with a PDUFA target date of April 2026 and multiple FDA designations, requiring precise protein engineering to cross the blood-brain barrier.Each of these programs illustrates the same truth: the distance between discovering a biological mechanism and delivering it to patients is defined by the quality of the cellular and manufacturing foundation underneath it.Avaí Bio (OTCQB: AVAI) recently announced the start of a key early-stage milestone alongside joint venture partner Austrianova: creating a Master Cell Bank of genetically modified cells that overexpress the a-Klotho protein. The MCB process clones a single engineered cell into tens of millions of identical copies, establishing the standardized cellular starting material from which all future working cell banks and therapy development for the Klothonova program will proceed.Prof. Walter H. Gunzburg, Chairman of Austrianova, said: "MCBs are a prerequisite for the production of Cell-in-a-Box® encapsulated cell products. They provide the foundation for sustainable production and ensure they meet the highest quality standards."The a-Klotho protein at the center of the Klothonova program is one of the most studied protective molecules in aging science. Peer-reviewed research links higher Klotho levels to reduced risk of Alzheimer's, cardiovascular disease, and certain cancers, while natural levels decline by approximately 50% after age 40. The addressable markets span Alzheimer's ($32.8 billion by 2033), cardiovascular disease (the world's leading cause of death), and kidney disease (850 million affected globally).Avaí Bio's dual-program approach also targets diabetes through the Insulinova platform, which, like Klothonova, leverages Austrianova's Cell-in-a-Box® encapsulation technology — a delivery system that protects therapeutic cells inside a biocompatible shell, allowing continuous protein secretion without immune rejection. The technology is backed by over 50 peer-reviewed publications.Every cell therapy begins with a single cell. The question is whether that cell has been properly characterized, cloned, and banked under the conditions required to support everything that comes after it. Avaí Bio (OTCQB: AVAI) just answered that question for its a-Klotho program — in a market heading toward $45 billion where the cellular foundation is what separates science from development.For more information on Avaí Bio (OTCQB: AVAI) and its Klothonova and Insulinova programs, visit USANewsGroup.comRead this and more news for Avaí Bio at: USANewsGroup.comArticle Source: https://usanewsgroup.com/avai-profile/ CONTACT:
USA NEWS GROUP
info @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avaí Bio, Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Avaí Bio, Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Avaí Bio, Inc. which were purchased in the open market. MIQ reserves the right to buy and sell, and will buy and sell shares of Avaí Bio, Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by MIQ has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:Straits Research, Global Cell Therapy Market 2026 — https://straitsresearch.com/report/cell-therapy-market Precedence Research, Cell and Gene Therapy Market Forecast — https://www.precedenceresearch.com/cell-and-gene-therapy-market Grand View Research, CAR T-Cell Therapy Market — https://www.grandviewresearch.com/industry-analysis/car-t-cell-therapy-market-report Astute Analytica, Regenerative Medicine Market 2025–2033 — https://www.globenewswire.com/news-release/2026/01/27/3226653/0/en/Regenerative-Medicine-Market-Review-2020-2024-and-Forecast-2025-2033-A-578-29-Bn-Opportunity-Says-Astute-Analytica.html Logo: https://mma.prnewswire.com/media/2838876/5656770/USA_News_Group_Logo.jpg



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Original: Advanced Cell-based Therapy Booming the Success for Healthcare Sector

Madrigal slides more than 5% as wider Q4 loss tempers strong sales growthFebruary 19, 2026 11:23 AM
IH Market News
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) shares fell 5.39% in premarket trading Thursday after the company reported fourth-quarter results that topped revenue expectations but delivered a larger-than-forecast loss.The biotechnology firm, which develops therapies for metabolic dysfunction-associated steatohepatitis (MASH), posted quarterly revenue of $321.1 million, ahead of the $310.82 million consensus estimate.However, earnings per share came in at -$2.57, missing analyst projections of -$0.60. The sharper-than-expected loss weighed on investor sentiment despite the revenue outperformance.For full-year 2025, Madrigal generated $958.4 million in net sales from Rezdiffra (resmetirom), a sharp increase from $180.1 million in 2024. The company said more than 36,250 patients were receiving Rezdiffra as of the end of 2025.“2025 marked a defining year for Madrigal. We solidified our position as the undisputed leader in MASH highlighted by nearly $1 billion in Rezdiffra sales in its first full year of launch,” said Bill Sibold, Chief Executive Officer of Madrigal. “And we’re just getting started – having penetrated only a fraction of a market that we believe has decades of growth ahead.”Madrigal ended the year with $988.6 million in cash, cash equivalents, restricted cash and marketable securities, up from $931.3 million at the close of 2024. The increase was largely driven by the establishment of a new credit facility in July 2025 that included a $350 million initial term loan.Operating expenses climbed significantly, reaching $380.7 million in the fourth quarter compared with $170.3 million in the same period a year earlier. For the full year, operating costs rose to $1.26 billion from $678 million in 2024, reflecting higher commercial spending related to Rezdiffra’s launch and upfront payments tied to business development deals.Madrigal has continued to broaden its MASH pipeline, advancing more than 10 programs at various stages of development. These include exclusive global licensing agreements for an oral GLP-1 receptor agonist and ervogastat, a Phase 2 oral DGAT-2 inhibitor that the company intends to evaluate in combination with Rezdiffra.Madrigal Pharmaceuticals stock price

Original: Madrigal slides more than 5% as wider Q4 loss tempers strong sales growth

Ribo and Ribocure Announce Exclusive Global Licensing Agreement with Madrigal for Novel siRNA Therapeutics Targeting MASHFebruary 11, 2026 6:49 AM
PR Newswire (US)

SUZHOU, China and MÖLNDAL, Sweden, Feb. 11, 2026 /PRNewswire/ -- Suzhou Ribo Life Science Co., Ltd. (HKEX: 06938) ("Ribo") and its subsidiary Ribocure Pharmaceuticals AB ("Ribocure") today announced that they have entered into an exclusive worldwide licensing agreement with Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) ("Madrigal") for six pre-clinical small interfering RNA (siRNA) programs for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
The collaboration will utilize Ribo's validated liver targeting siRNA GalSTARTM platform to develop novel treatments for MASH. The license agreement covers multiple existing pre-clinical assets from Ribo. In addition, both parties have the option to expand the scope of collaboration onto new siRNA programs including bi-specific siRNAs (agents that target two disease-causing genes simultaneously) utilizing Ribo's unique GalSTARTM and siRNA chemical modification platforms.We are enthusiastic to join forces with Madrigal Pharmaceuticals, drawing on their extensive knowledge together with our siRNA expertise to advance life changing therapies for people affected by liver disease, says Dr. Zicai Liang, CEO of Ribo.To have the opportunity to work with the company that successfully launched the world's first drug for MASH, a disease with rising prevalence and strong associations with numerous life-threatening comorbidities, is very encouraging. Leveraging our proprietary siRNA platform, we aim to expand the MASH therapeutic landscape through complementary, multi-mechanistic approaches, delivering more targeted and effective treatments for patients with unmet needs, says Dr Li-Ming Gan CEO of Ribocure and co-CEO of Ribo.Financial Considerations
Under the agreement, Ribo has granted Madrigal an exclusive global license to develop, manufacture, and commercialize several siRNA assets. Ribo will receive an upfront payment of US$60M and cumulative payments could reach US$4.4B if certain development, regulatory and commercial milestones are achieved, as well as potential royalties on net sales.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 Suzhou Ribo Life Science Co. Ltd. and Ribocure Pharmaceuticals AB
Suzhou Ribo Life Science Co. Ltd. (HKEX: 6938) is an innovative clinical stage R&D company devoted to the development of nucleic acid drugs and related products based on the RNA interference (RNAi) technology. With its innovative R&D capabilities with vertically integrated technological platforms, Ribo has built a strong product pipeline, aiming to make contribution to the treatment of serious diseases with unmet medical needs.As a subsidiary of Suzhou Ribo Life Science, Ribocure Pharmaceuticals AB is dedicated to globalized development of life-saving oligonucleotide therapies, with focus on development of assets and pipeline as well as new target ideas and on building innovative capacities to conduct clinical trials and developing siRNA drugs to address real unmet medical needs globally.For more information, please visit www.ribolia.com and www.ribocure.comAbout Madrigal PharmaceuticalsMadrigal 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-ß agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com.Logo - https://mma.prnewswire.com/media/2804420/5793713/logo_Ribolia_Logo.jpg 



View original content:https://www.prnewswire.co.uk/news-releases/ribo-and-ribocure-announce-exclusive-global-licensing-agreement-with-madrigal-for-novel-sirna-therapeutics-targeting-mash-302685038.html

Original: Ribo and Ribocure Announce Exclusive Global Licensing Agreement with Madrigal for Novel siRNA Therapeutics Targeting MASH

Ribo and Ribocure Announce Exclusive Global Licensing Agreement with Madrigal for Novel siRNA Therapeutics Targeting MASHFebruary 11, 2026 6:25 AM
PR Newswire (US)

SUZHOU, China and MÖLNDAL, Sweden, Feb. 11, 2026 /PRNewswire/ -- Suzhou Ribo Life Science Co., Ltd. (HKEX: 06938) ("Ribo") and its subsidiary Ribocure Pharmaceuticals AB ("Ribocure") today announced that they have entered into an exclusive worldwide licensing agreement with Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) ("Madrigal") for six pre-clinical small interfering RNA (siRNA) programs for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).







The collaboration will utilize Ribo's validated liver targeting siRNA GalSTARTM platform to develop novel treatments for MASH. The license agreement covers multiple existing pre-clinical assets from Ribo. In addition, both parties have the option to expand the scope of collaboration onto new siRNA programs including bi-specific siRNAs (agents that target two disease-causing genes simultaneously) utilizing Ribo's unique GalSTARTM and siRNA chemical modification platforms.We are enthusiastic to join forces with Madrigal Pharmaceuticals, drawing on their extensive knowledge together with our siRNA expertise to advance life changing therapies for people affected by liver disease, says Dr. Zicai Liang, CEO of Ribo.To have the opportunity to work with the company that successfully launched the world's first drug for MASH, a disease with rising prevalence and strong associations with numerous life-threatening comorbidities, is very encouraging. Leveraging our proprietary siRNA platform, we aim to expand the MASH therapeutic landscape through complementary, multi-mechanistic approaches, delivering more targeted and effective treatments for patients with unmet needs, says Dr Li-Ming Gan CEO of Ribocure and co-CEO of Ribo.Financial Considerations
Under the agreement, Ribo has granted Madrigal an exclusive global license to develop, manufacture, and commercialize several siRNA assets. Ribo will receive an upfront payment of US$60M and cumulative payments could reach US$4.4B if certain development, regulatory and commercial milestones are achieved, as well as potential royalties on net sales.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 Suzhou Ribo Life Science Co. Ltd. and Ribocure Pharmaceuticals AB
Suzhou Ribo Life Science Co. Ltd. (HKEX: 6938) is an innovative clinical stage R&D company devoted to the development of nucleic acid drugs and related products based on the RNA interference (RNAi) technology. With its innovative R&D capabilities with vertically integrated technological platforms, Ribo has built a strong product pipeline, aiming to make contribution to the treatment of serious diseases with unmet medical needs.As a subsidiary of Suzhou Ribo Life Science, Ribocure Pharmaceuticals AB is dedicated to globalized development of life-saving oligonucleotide therapies, with focus on development of assets and pipeline as well as new target ideas and on building innovative capacities to conduct clinical trials and developing siRNA drugs to address real unmet medical needs globally.For more information, please visit www.ribolia.com and www.ribocure.comAbout Madrigal PharmaceuticalsMadrigal 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-ß agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). For more information, visit www.madrigalpharma.com.



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Original: Ribo and Ribocure Announce Exclusive Global Licensing Agreement with Madrigal for Novel siRNA Therapeutics Targeting MASH

I think MDGL needs to make a strategic move and build the pipeline someone will will buy SGMT sooner than later Thierry the CFO at Sagimet has tentacles around the pharma sector. I think LLY Novo or Gilead or AMGN sneak in and make a strategic move with sgmt.
The street not impressed with the F4 data nearly 40% of the patients had diarrhea. This way they can bullet proof the nash space and then be able to enter the obesity market with FASN fat synthesis THR Beta combination single oral tablets and or triple tablet GLP1 FASN and THR Beta I can't believe SGMT hasn't been bought out with Break Through designation for MASH 3100 Patients Phase 3's.

$MDGL

"MASLD" and "MASH" are new terms for previously known conditions like non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), respectively. The name change reflects a shift in understanding the causes of these liver conditions, with a greater emphasis on metabolic dysfunction as a primary driver.
MASH: A More Severe Form of MASLD

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease):
.

This umbrella term describes fatty liver disease where fat accumulates in the liver due to factors like obesity, type 2 diabetes, or high blood pressure.
MASH (Metabolic Dysfunction-Associated Steatohepatitis):
.
A more advanced stage of MASLD where the fat buildup has led to inflammation, liver damage, and in some cases, scarring (fibrosis).

Growing Concern: The Increasing Prevalence of MASLD and MASH

MASLD is a major global health concern, with a rapidly increasing prevalence worldwide.

The rising rates of obesity, type 2 diabetes, and metabolic syndrome are major contributors to the growth of MASLD and MASH.
MASH is projected to become a leading cause of liver transplants and cirrhosis in the United States.
The potential for liver cancer (hepatocellular carcinoma) is a serious complication of MASLD, particularly with advanced fibrosis or cirrhosis.

Key Takeaways

MASLD and MASH are significant and growing health problems, especially in regions with high rates of obesity and metabolic disorders.

Early detection and management of MASLD and MASH are crucial to prevent progression to more severe forms of liver disease, such as cirrhosis and liver cancer.
Lifestyle changes, including weight loss, healthy eating, and regular physical activity, can be effective in managing MASLD and MASH.
If you are concerned about your risk for MASLD or MASH, it's important to consult with a healthcare professional for proper evaluation and management.

Metabolic dysfunction-associated steatohepatitis (MASH)
MASLD is an umbrella term for conditions caused by the build-up of extra fat in the liver that is not caused by alcohol intake. As...
Novo Nordisk

Nonalcoholic fatty liver disease - Symptoms and causes - Mayo Clinic
Apr 4, 2024 — NASH causes the liver to swell and become damaged due to the fat deposits in the liver. NASH may get worse and may lead...
Mayo Clinic
Nonalcoholic Fatty Liver Disease - Johns Hopkins Medicine
Based on the test results, your healthcare provider will make the following diagnosis: * You have MASLD if you have fat but no in...
Johns Hopkins Medicine

Show all

This is for informational purposes only. For medical advice or diagnosis, consult a professional. AI responses may include mistakes.
Cases of MASH would increase from 14.9 million (5.8% of US adults) in 2020 to 23.2 million (7.9% of US adults) by 2050. The number of cases of MASH and clinically significant fibrosis (ie, F=F2, centrilobular and periportal fibrosis or more severe disease) were estimated to increase from 6.7 million to 11.7 million

Madrigal CEO on Q4 earnings beat, MASH drug market opportunity
https://www.cnbc.com/video/2025/02/26/madrigal-ceo-on-q4-earnings-beat-mash-drug-market-opportunity.html

$MDGL

IP goes to SGMT good through 2048 this is going to be 1 tablet combo of the two drugs looks like M&A has started.
Combination of denifanstat and resmetirom (MDGL):
• Application filed 2024; if granted—2044; potential PTE to 2048

Combination of fatty acid synthase (FASN) inhibitor and Madrigal's thyroid hormone receptor beta (THRb) agonist resmetirom shows
synergistic improvement of NAFLD activity score (NAS) within 6-weeks
in diet-induced obese mice with biopsy-confirmed MASH
33% FASN
23% Resmetirom
80% Combo of the two drugs improved each component of NAFLD

$MDGL

Started to Nibble on some madrigal options late 2025 holding my core position from the 70.00's AKRO shit data makes MDGL more valuable.
Interesting Madrigal and Sagimet doing a single pill combo of their two drugs soon. Does Madrigal take out Sagimet or does a bigger player show up Bill Sibold Deeper pocket BP like LLY Gilead Novo or Novartis can scoop up on SGMT and not even Flinch they have the best looking oral in the space that works wonders with ThR B and GLP1 like Ozempic in combos a blockbuster stand alone first Line F2 F3 & F4 and a blockbuster for combos with GLp1 42% fibrosis reduction vs 0% in placebo.

$MDGL

MDGL under $350

Combination of fatty acid synthase (FASN) (SGMT) inhibitor and thyroid hormone receptor beta (THRb) agonist MDGL resmetirom shows
synergistic improvement of NAFLD activity score (NAS) within 6-weeks by 80% in combination
in diet-induced obese mice with biopsy-confirmed MASH
https://sagimet.com/wp-content/uploads/2024/06/2024-EASL-poster-GAN-model-final.pdf

Who is MDGL going to partner with or buy to expand their pipeline!
My guess Madrigal does something SGMT and then Sanofi buys MDGL!
$MDGL

Madrigal most likely will announce a partnership or buyout to strengthen their pipeline. I think SGMT is a logical choice.

Their fat synthesizer enhances the efficacy of Rezdiffra (resmetirom) when in combo with Denifanstat off the Charts results.

Combination of fatty acid synthase (FASN) inhibitor and thyroid hormone receptor beta (THRb) agonist resmetirom shows synergistic improvement of NAFLD activity score (NAS) within 6-weeks in diet-induced obese mice with biopsy-confirmed MASH

EASL International Liver Congress
Date - 06/2024
poster
Combination of fatty acid synthase (FASN) inhibitor and thyroid hormone receptor beta (THRb) agonist, resmetirom, improved markers of MASH and cardiovascular health in LDL receptor .
knockout MASH mice.

I started buying MDGL at $70 a few years ago when everyone was talking it down!



$MDGL

shorts are about to get obliterated core Holding in since $70.00 not selling any shares till $750.00

Thanks!

Nice pickup! Congrats

Bought some $MDGL on the dip today ahead of March 14th FDA meeting

MDGL’s CEO and CCO both resigned during_the_past_two_weeks—what’s up?

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001157601/000119312523234395/d444513d8k.htm (CEO)

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001157601/000119312523241315/d684437d8k.htm (CCO)

Just bought 20 shares at 192. Scaling back in after being in it ahead of December's big move and selling. Hopefully things go well here and we get FDA approval and a buyout eventually

$MDGL: HEPA is the Cheapest value in NASH space

If you really love the NASH space.

Doesn't get better than that and HEPA competes HEAD ON with MDGL in the same space.


Other than that.............. never heard of you here before so, whatever


GO $MDGL

$500 will be here soon enough!

$MDGL

Riding free shares 300% profits last week was holding for 6 months worth the wait being patient & nailed some of the Jan 2023 calls a few weeks ago. It's going to go higher! 300 Million in financing to complete remaining trails Nash market is worth tens of Billions of dollars should be years ahead of the rest. Look for Buyout in 2023.

$MDGL

Moew like $185.

$MDGL: Largest OI right now is Jan20,2023 $120puts

Currently at 0.30


MDGL management would be idiots if they didn't do a Secondary OFFERING now to collect some easy cash.

Im starting to look at these contracts, getting pretty tempting


GO $MDGL

$MDGL: WOW ..... 315......... going to $400 ???

Won't shock me at all if and when it happens


Seen this happen before on $ICPT


GO $MDGL

$MDGL: Killing it now......... OVER 300 !!!!!!!!!!!!

Without a doubt.................. , the BEST STOCK OF THE WEEK ANYWHERE.

And theres only how many, 3 of us here

Only ballers here

Can't believe $HEPA hasnt boosted here and its all in the NASH space like $MDGL.
Even VKTX in the NASH space is getting a boost from MDGL.
$HEPA should be over a $1 with this MDGL draftwinds


WOW


GO $MDGL

Wait, is this ganna create sell off tomorrow?

4:19
News Detail
TI
Madrigal Pharmaceuticals raised $239 ml in gross equity from equity securities issuances and additional $50 mln in liquidity commitments
4:18 PM ET 12/21/2022 | Briefing.com
MDGL
Co announces that it has raised $259 million in gross equity (or $255 million in net proceeds) from equity securities issuances and an additional $50 million in liquidity commitments following the achievement of the clinical milestone under its Hercules Credit
Facility.Madrigal has completed $159 million in gross sales of common stock under its ATM Program ("ATM
Sales") and has separately entered into a $100 million definitive securities purchase agreement with two of its existing institutional investors for the purchase of $90 million in shares of Series B Convertible Preferred
Stock (the "Series B") and $10 million in shares of the Company's common stock.In connection with Madrigal's December 19, 2022 announcement of positive topline data from its pivotal Phase 3
MAESTRO-NASH clinical trial of resmetirom, Hercules Capital, Inc. (HTGC) confirmed that Madrigal has achieved its clinical milestone under the Company's Credit Facility with Hercules, thereby enabling Madrigal to draw upon a $50 million clinical milestone tranche over the next three months.

Oh, well

There are no set rules regarding how long a short sale can last before being closed out. The lender of the shorted shares can request that the shares be returned by the investor at any time, with minimal notice, but this rarely happens in practice so long as the short seller keeps paying their margin interest.

Shorting stocks should be more strict than this….

I am sure a lot of traders are shorting MDGL already. How soon do they have to cover the short? Do you know?

$MDGL: JUst amazing now............ 275 !!!!!!!!!!


WOW......... still no offfering.

This is sooooooooooooo incredible.


Those Calls are now $168 !!!!!!!!!!!!!

WOW....... they were only $13 last week


AMAZZZZZZZZZZINGGGGGGGGGGGGGGGGGGGGGGGgg


Reminds me of the boost in $ICPT several years ago


GO $MDGL

MDGL might be holding well because smart investors know FDA approval is imminent or merger and buyout. I am expecting much higher price or the deal.

$MDGL has $49.81M DEBT, Book value is only $.62

MDGL > 52-week serial liver biopsy Phase 3 study in more than 950 patients, resmetirom achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses, 80 mg and 100 mg, relative to placebo
NASH resolution (ballooning of 0, inflammation of 0-1) and greater-than or equal to2-point NAS reduction with no worsening of fibrosis (p<0.0001 at both doses)
Fibrosis improvement by at least one stage with no worsening of NAS (p=0.0002 and <0.0001 at 80 and 100 mg, respectively)
Potentially clinically meaningful LDL-lowering, a key secondary endpoint (p<0.0001)
Multiple positive effects on NASH biomarkers and imaging
Resmetirom was safe and well-tolerated in the MAESTRO-NASH study, consistent with the overall safety in Phase 3 MAESTRO trials, expanding the large safety database
Madrigal intends to file a new drug application seeking accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis

$MDGL: Thanks for that......... I hope AADI

Has a similar Stratospheric BOOST like $MDGL just did.


Congrats on that MEGA WINNER


Merry XMAS


GO $MDGL

I saw your post sent you a heads up

$MDGL : Some genius grabbed 3200 Jan2023 $100calls on Thursday

WOW............... Those are up massive now.


Premium was at $13 on Friday last week........... now at $115


AMAZING


GO $MDGL

Just in case 87 went to 220

87 today as well lol. I knew I should have sold half once it past $90

$87 today
Looks like the big guys had their specialist look at those Phase III results and see something good. NASH is a disease with no approved treatment. Last drug to go before an Advisory Panel was denied because benefit did not outweigh the risk.
Madrigals big phase III safety trial just passed with flying colors. Folks looking to get in ahead of the FDA awarded "accelerated approval" status.

Keeps inching up

Iook like earnings or something coming end of feb. Maybe a fire will be lit then

Now its getting attention.

Share price could care less tho lol

Great news today!

News in the AM, pre announced today... see if I can get some premarket shares

Piper Sandler presentation
60mg dose not in phase 3 showed 19% NASH Resolution
80 mg dose in phase 2 trial = 38% resolution
Better is that the phase 3 trial has a 100mg arm and with the safety data coming in it looks like the ideal dose for an even higher resolution percentage.

Also, the company has been in talks with multiple Big Pharma about partnering. Madrigal feel confident enough that they feel no partnering will take place until after the final phase 3 data is presented in 2022.

Glad this one is off the radar and may give me another chance to add shares at lower prices.

Madrigal at 52 week lows because it is off the radar
Phase 3 NAFLD results coming soon and I'll be looking for a clean safety profile and indications nonintrusive biomarkers can be used to follow therapy and to diagnose NASH (not NAFLD).

Looking back at Phase 2 results confirmed with biopsy in NASH phase 2 trial
Madrigal’s MGL-3196 Achieves Liver Biopsy Endpoints

Statistically significantly more patients treated with MGL-3196 compared with placebo treated patients achieved a two point reduction in NAS (NAFLD activity score) on biopsy --

-- Statistically significantly more patients treated with MGL-3196 compared with placebo treated patients achieved resolution of NASH on biopsy --

Current phase 3 trial will dose 52 weeks not the 36 weeks in the phase 2 trial. The current phase 3 trial will also be based on higher doses that were much more effective at reducing liver fat by >50%. 50% liver fat reduction is considered ideal to see liver improvement.

Two phase 3 trials with focus on NASH. NAFLD arm will likely be difficult to show improvement over placebo in a short term trial. The NAFLD news coming soon is an expected buying op for me as the headliner will be about treating NAFLD for 52 weeks probably being the headline and an op for Wall Street to attack the price so that they can collect cheaper shares before NASH results next year.

I heard there was news today but I can’t find it. Anyone know of anything?

BioVie is unbelievably way under-the-radar. It is the most undervalued NASH related stock you can find in the market. Mr. Terren Peizer saw the great potential of this company, not to mention Mallinckrodt's (MNK) interest on BioVie's Technology Platform, thus initiating a IP patent challenge with the USPTO which I think the deciding factor that led him to embark in this microcap company. Considering his profile, I believe BioVie is in good hands. All this in my opinion only.

BioVie, Inc. (BIVI)
Pioneering therapies for advanced liver disease
Non-confidential investor presentation | December 2018

***A new treatment option is emerging for refractory ascites
Based on investigative studies in Italy and Australia
***Terlipressin (BIV201’s active agent) is approved in 40+ countries for
treating related liver cirrhosis complications (HRS & BEV*)

***BIV201 is a new drug candidate in the US
Terlipressin is not available in the US or Japan

***Currently in US phase 2 clinical
trials; seeking to replicate
European & Australian
investigative study results

***BIV201 offers advantages in 40+ countries where
Terlipressin is already approved
Targeting improved efficacy and safety compared to IV bolus dosing

***Clinically de-risked development program
The same therapy that is currently in use in Italy and Australia

***US patent protection
through 2036

***Filed for patents in Japan,
China & Europe

***US Orphan Drug designations for
both ascites and HRS to enable 7
years of market exclusivity

***FDA Fast Track status; will seek
Breakthrough Therapy designation


https://www.biovieinc.com/wp-content/uploads/2019/01/BioVie-Non-Conf-Deck_Dec_2018.pdf