Core Insights - Madrigal Pharmaceuticals reported strong second-quarter 2025 results, driven by high demand for its product Rezdiffra, with net sales reaching $212.8 million, a significant increase from $14.6 million in the same period last year [4][7]. Corporate Strategy and Developments - The company secured a new U.S. patent for Rezdiffra, extending its protection until February 4, 2045, which is crucial for maintaining its market position [5]. - Madrigal announced a global licensing agreement for an oral GLP-1 development candidate, SYH2086, which is expected to enter clinical trials in the first half of 2026 [5]. - The company has strengthened its financial position by securing up to $500 million in senior secured credit to advance its pipeline [5]. - Positive data from a two-year study on F4c MASH patients was presented, indicating broad and sustained efficacy, which supports the ongoing MAESTRO-NASH OUTCOMES trial [5][9]. Financial Performance - Total revenues for the second quarter of 2025 were $212.8 million, compared to $14.6 million in the same quarter of 2024, reflecting a substantial increase in Rezdiffra demand [7]. - Operating expenses for the second quarter were $260.0 million, up from $177.2 million year-over-year, primarily due to increased commercial activities [7]. - The company reported a net loss of $42.3 million for the second quarter of 2025, compared to a net loss of $152.0 million in the same period last year [24]. Market Opportunity - The estimated market opportunity for F4c MASH patients in the U.S. is approximately 245,000 individuals currently under the care of liver specialists [12]. - Madrigal aims to address the needs of around 315,000 patients with moderate to advanced fibrosis in the U.S. [11]. Leadership Changes - Dan Brennan was appointed to the Board of Directors, bringing extensive experience from his previous role as Executive Vice President and Chief Financial Officer of Boston Scientific [6].

临床前数据显示，SYH2086具有优异的体外激动活性和体内降糖、减重效果，并在不同动物种属上具有 宽剂量范围线性化的药物动力学(PK)行为，且无明显安全性风险。 （企业公告） 近日，石药集团发布与MADRIGAL就SYH2086订立独家授权协议的公告。披露集团已与Madrigal Pharmaceuticals, Inc.就本集团的口服小分子激活胰高血糖素样肽-1（"GLP-1"）受体激动剂SYH2086在 全球的开发、生产及商业化订立独家授权协议。 根据该协议的条款，本集团同意授予Madrigal在全球范围内开发、生产及商业化SYH2086的独家授权， 同时保留本集团在中国开发和销售其他口服小分子GLP-1受体激动剂产品的权益。本集团有权收取最高 可达20.75亿美元的总代价，包括1.2亿美元的预付款、最高可达19.55亿美元的潜在开发、监管及商业里 程碑付款，以及基于SYH2086年度淨销售额的高达双位数销售提成。 SYH2086是集团开发的具有完全自主知识产权的临床前候选药物，属于一种新型口服小分子GLP-1受体 激动剂。GLP-1受体激动剂是一类通过GLP-1受体发挥作用的药物，已被开发为用于2型糖尿 ...

Company Overview - Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has been performing well in sales with its FDA-approved drug Rezdiffra (resmetirom), which is indicated for the treatment of adults with non-cirrhotic non-alcoholic fatty liver disease [2] Market Analysis - The Biotech Analysis Central service offers a comprehensive analysis of over 600 biotech investing articles and a model portfolio featuring more than 10 small and mid-cap stocks, providing in-depth analysis and live chat for healthcare investors [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示概不就因本公告全部或任何部份內容而產生 或因倚賴該等內容而引致的任何損失承擔任何責任。 CSPC PHARMACEUTICAL GROUP LIMITED SYH2086是本集團開發的具有完全自主知識產權的臨床前候選藥物，屬於一種新型口服小 分子GLP -1受體激動劑。GLP -1受體激動劑是一類通過GLP -1受體發揮作用的藥物，已被開 發 為 用 於 2 型 糖 尿 病 和 肥 胖 症 管 理 的 治 療 方 法 ， 其 核 心 作 用 機 制 包 括 促 進 胰 島 素 分 泌 、 抑 制 胰 高 血 糖 素 釋 放 、 延 緩 胃 排 空 及 降 低 食 欲 ， 從 而 兼 具 降 糖 和 減 重 效 果 。 臨 床 前 數 據 顯 示，SYH2086具有優異的體外激動活性和體內降糖、減重效果，並在不同動物種屬上具有 寬劑量範圍線性化的藥物動力學(PK)行為，且無明顯安全性風險。 – 1 – 關於Madrigal Madrigal（ NASDAQ：MDGL ）是一家專注於提供代謝功能 ...

Core Insights - Madrigal Pharmaceuticals has entered into an exclusive global license agreement with CSPC Pharmaceutical Group for SYH2086, a preclinical oral GLP-1 receptor agonist, with plans to initiate clinical development in the first half of 2026 [1][2][3] Group 1: Company Developments - The agreement aligns with Madrigal's long-term goal to enhance its leadership in MASH by building a pipeline anchored by its existing product, Rezdiffra [2] - Madrigal's CEO highlighted the successful launch of Rezdiffra and the acquisition of new intellectual property protection through 2044 as part of their strategic priorities [2] - The combination of Rezdiffra and SYH2086 is expected to provide a best-in-class oral treatment for patients with MASH [2][6] Group 2: Financial Aspects - CSPC will receive an upfront payment of $120 million and may earn up to $2 billion in milestone payments based on the achievement of specific development, regulatory, and commercial milestones [3] - The transaction is expected to close in the fourth quarter of 2025, pending regulatory clearance [3] Group 3: Product Information - SYH2086 is a novel oral small molecule GLP-1 receptor agonist that has shown promising preclinical results, including glucose-lowering and weight-loss effects [4] - GLP-1 receptor agonists are designed to manage type 2 diabetes and obesity by enhancing insulin secretion and reducing appetite [4] Group 4: Industry Context - MASH is a serious liver disease that can lead to severe complications, including cirrhosis and liver cancer, and is a leading cause of liver transplantation [5][7] - The prevalence of MASH is expected to increase, highlighting the need for effective treatments [7]

Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its second-quarter 2025 financial results on August 5, 2025, before the U.S. financial markets open [1] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - The company's primary medication, Rezdiffra (resmetirom), is a once-daily oral THR-β agonist targeting the underlying causes of MASH and is the first FDA-approved treatment for MASH with moderate to advanced fibrosis [3] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for treating compensated MASH cirrhosis [3] Investor Relations - Following the financial results announcement, Madrigal's management will host a live webcast at 8 a.m. Eastern Time to discuss the financial and operational results [2] - The webcast will be accessible via the Investor Relations section of the Madrigal Pharmaceuticals website, with a recommendation for participants to register at least 15 minutes prior to the event [2]

CONSHOHOCKEN, Pa., July 22, 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 has entered into a $500 million senior secured credit facility with funds managed by Blue Owl Capital (NYSE: OWL), a leading alternative asset manager, to primarily advance Madrigal's pipeline to further extend its leadership position in MASH. The non-dilut ...

Core Insights - Madrigal Pharmaceuticals (MDGL) shares increased by 10.9% following the U.S. Patent and Trademark Office's Notice of Allowance for a new patent related to the FDA-approved dosing regimen of its product Rezdiffra (resmetirom) [1][7] Company Developments - In 2024, the FDA granted accelerated approval to Rezdiffra, making it the first and only approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) [2] - The new patent will protect Rezdiffra until September 30, 2044, and will be listed in the FDA's Orange Book, preventing generic competition and enhancing market exclusivity [3][7] - As of March 31, 2025, over 17,000 patients are currently receiving Rezdiffra treatment, indicating strong early demand [4][7] Clinical Pipeline - Madrigal Pharmaceuticals is awaiting a final decision on its regulatory filing for Rezdiffra for the MASH indication in the EU, expected in August [8] - The ongoing pivotal phase III MAESTRO-NASH biopsy study aims to provide long-term safety and efficacy data to support full approval of Rezdiffra for noncirrhotic MASH [9] - A second phase III outcomes study (MAESTRO-NASH OUTCOMES) is evaluating the drug's effectiveness in patients with compensated MASH cirrhosis, with top-line data expected in 2027 [10] - The open-label extension of the MAESTRO-NAFLD-1 study shows that patients treated with Rezdiffra achieved significant reductions in liver damage over two years [11][12] Market Performance - Year-to-date, MDGL shares have gained 11.8%, outperforming the industry growth of 6.3% [6]

Company Overview - Madrigal (MDGL) shares increased by 10.9% to close at $344.97, with notable trading volume compared to typical sessions, and an overall gain of 11.3% over the past four weeks [1][2] Patent and Market Exclusivity - Madrigal received a Notice of Allowance for a new U.S. patent for Rezdiffra, its FDA-approved drug for noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), which is valid through 2044 and will enhance market exclusivity by blocking generics [2] Financial Performance Expectations - The company is expected to report a quarterly loss of $3.64 per share, reflecting a year-over-year increase of 48.7%, while revenues are projected to be $160.13 million, up 993.8% from the previous year [3] Earnings Estimate Trends - The consensus EPS estimate for Madrigal has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Comparison - Madrigal operates within the Zacks Medical - Drugs industry, where another company, Corcept Therapeutics (CORT), closed 2% higher at $72.85, with a return of -0.6% over the past month [4]

Core Insights - Madrigal Pharmaceuticals has received a Notice of Allowance from the USPTO for Rezdiffra™, the first FDA-approved treatment for adults with noncirrhotic MASH with moderate to advanced liver fibrosis [1][2] - The patent protection for Rezdiffra is set to last until September 30, 2044, and will be included in the FDA's Orange Book [2] - The CEO of Madrigal emphasized that this milestone supports the company's long-term strategy for Rezdiffra and highlights the significance of their clinical development program [3] Company Overview - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [3] - Rezdiffra (resmetirom) is a once-daily oral THR-β agonist aimed at addressing the underlying causes of MASH, specifically approved for patients with moderate to advanced fibrosis (F2 to F3 stages) [3] - An ongoing Phase 3 trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c stage) [3]