CONSHOHOCKEN, Pa., Oct. 07, 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 October 1, 2025 to 27 new non-executive employees as equity inducement awards under the terms of Madrigal's 2025 Inducement Plan. The equity awards were approved by Madrigal's independent Compensation Committee in accordance with Nasd ...

Madrigal Pharmaceuticals (NASDAQ: MDGL ) has quickly become a major player in metabolic liver disease treatments with Rezdiffra (resmetirom), which is indicated for F2-F3 MASH. This drug was authorized under accelerated approval in the US and is already showing blockbuster potential. This is despite havingMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohi ...

Madrigal Pharmaceuticals (NASDAQ: MDGL ) has quickly become a major player in metabolic liver disease treatments with Rezdiffra (resmetirom), which is indicated for F2-F3 MASH. This drug was authorized under accelerated approval in the US and is already showing blockbuster potential. This is despite havingMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohi ...

Group 1 - Madrigal Pharmaceuticals, Inc. will participate in the Morgan Stanley 23 Annual Global Health Care Conference on September 8, 2025, at 7:45 A.M. EDT [1] - The presentation will be available via live webcast and a replay will be accessible after the event [1] Group 2 - Madrigal Pharmaceuticals focuses on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's medication, Rezdiffra (resmetirom), is the first and only FDA and European Commission approved treatment for MASH with moderate to advanced fibrosis (F2 to F3) [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [2]

Core Insights - Madrigal Pharmaceuticals (MDGL) received conditional marketing authorization from the European Commission for Rezdiffra (resmetirom) to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced liver fibrosis [1][7] - Rezdiffra is the first and only therapy approved for MASH in the European Union, based on positive data from the pivotal phase III MAESTRO-NASH study [2][3] - The first European launch of Rezdiffra is anticipated in Q4 2025, starting in Germany, and it is already included as a first-line treatment in European MASH guidelines [3] Market Performance - Year-to-date, shares of Madrigal have increased by 23%, outperforming the industry average rise of 9.1% [4] - Despite the EU approval, MDGL stock fell by 3% on August 19 due to investor concerns over competition from Novo Nordisk's Wegovy [6][7] Competitive Landscape - Wegovy, a GLP-1 drug from Novo Nordisk, received accelerated approval from the FDA for treating noncirrhotic MASH, marking it as the first GLP-1 therapy approved for this condition [8][9] - Analysts suggest Wegovy's established safety profile and benefits in metabolic disease may position it as a preferred treatment for MASH, potentially impacting Rezdiffra's market position [9] Sales and Demand - Rezdiffra's commercial launch in the U.S. has shown strong initial demand, generating sales of $212.8 million in Q2 2025, a sequential increase of nearly 55% [11] - As of June 30, 2025, over 23,000 patients are currently receiving treatment with Rezdiffra [11]

Core Viewpoint - Madrigal Pharmaceuticals has received conditional marketing authorization from the European Commission for Rezdiffra, making it the first approved therapy for metabolic dysfunction-associated steatohepatitis (MASH) in the European Union [1][10]. Company Overview - Madrigal Pharmaceuticals, Inc. is focused on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [12]. - Rezdiffra (resmetirom) is a once-daily, oral, liver-directed THR-β agonist designed to address the underlying causes of MASH [8][12]. Product Details - Rezdiffra is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2-F3) [9][10]. - The European Commission's decision was based on positive results from the Phase 3 MAESTRO-NASH trial, which demonstrated fibrosis reduction and MASH resolution [3][6]. - At one year, 91% of patients treated with Rezdiffra 100 mg showed improvement or stabilization of liver stiffness [3]. Market Context - MASH is a leading cause of liver-related mortality and is increasingly burdening healthcare systems globally, with approximately 370,000 patients diagnosed in Europe [2][5]. - The approval of Rezdiffra is expected to set a precedent in the treatment of MASH, as it does not require a biopsy for treatment qualification [2][4]. Regulatory Approval - The approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025 [4]. - Rezdiffra is included in European MASH treatment guidelines and is expected to launch in Germany in the fourth quarter of 2025 [4][6].

Company Overview - Madrigal Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a liver disease with significant unmet medical needs [2] - The company's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist targeting key underlying causes of MASH [2] - Rezdiffra is the first and only medication approved by the FDA for treating MASH with moderate to advanced fibrosis, specifically stages F2 to F3 [2] - An ongoing Phase 3 outcomes trial is assessing Rezdiffra for the treatment of compensated MASH cirrhosis, corresponding to stage F4c [2] Upcoming Events - Madrigal Pharmaceuticals will participate in the Canaccord Genuity 45 Annual Growth Conference on August 12, 2025, at 10:30 A.M. EDT [1] - The presentation will be available via a live webcast, with a replay accessible after the event [1]

NASDAQ: MDGL © 2025 Madrigal Pharmaceuticals, Inc. All rights reserved. Forward-looking Statements This presentation includes "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, that are based on Madrigal's beliefs and assumptions and on information currently available to it but are subject to factors beyond its control. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regar ...

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].

Summary of CSPC Pharmaceutical Group Conference Call Company and Industry Overview - **Company**: CSPC Pharmaceutical Group (Ticker: 1093.HK) - **Industry**: China Healthcare Key Points and Arguments - **Licensing Agreement**: CSPC has signed a licensing agreement with Madrigal for exclusive development and commercial rights to SYH2086, an oral GLP-1 in preclinical stage. The deal includes an upfront fee of **US$120 million**, potential total milestones of up to **US$1.955 billion**, and a double-digit share of sales royalties [1][6] - **Madrigal's Asset**: Madrigal's lead asset, Rezdiffra (resmetirom), is a once-daily oral THR-beta agonist approved for F2-F3 MASH by the US FDA in March 2024 and is currently undergoing Phase 3 trials for F4c MASH [1] - **Financial Position of Madrigal**: As of March 2025, Madrigal holds **US$848 million** in cash and has a **US$500 million** secured credit facility [1] - **Out-licensing Deals**: This marks CSPC's sixth out-licensing deal in the last 10 months, indicating the company's strong drug discovery platforms and commitment to globalization. The deal is viewed as a positive surprise and is not part of the anticipated **~US$5 billion** in out-licensing deals expected to be completed in 2025 [6] - **Future Expectations**: CSPC is expected to announce two more major out-licensing deals, specifically for SYS6010 (EGFR ADC) and another technology platform [6] Financial Metrics and Valuation - **Stock Rating**: Overweight - **Price Target**: HK$9.60 - **Current Stock Price**: HK$10.10 (as of July 30, 2025) - **Market Capitalization**: HK$120,751 million - **Revenue Projections**: - 2025: **Rmb 29,036 million** - 2026: **Rmb 30,513 million** - 2027: **Rmb 30,978 million** [4] - **Earnings Per Share (EPS)**: - 2025: **Rmb 0.45** - 2026: **Rmb 0.46** - 2027: **Rmb 0.44** [4] - **Valuation Methodology**: Discounted cash flow methodology with a cost of equity of **10.1%** and a perpetual growth assumption of **4%** [7] Risks Identified - **Upside Risks**: - Stronger-than-expected sales ramp-up for innovative drugs - Better-than-expected margin improvement - Pipeline advancement - Increasing business development [9] - **Downside Risks**: - API price fluctuations - Pipeline failures or delays - Rising operating costs - Government price cuts or reimbursement controls [9] Additional Insights - **Analyst Certification**: Analysts involved have certified that their views are accurately expressed and have not received compensation for specific recommendations [14] - **Market Activity**: CSPC is actively involved in the market, with Morgan Stanley acting as a liquidity provider for its securities [57] This summary encapsulates the critical aspects of CSPC Pharmaceutical Group's recent developments, financial outlook, and market positioning, providing a comprehensive overview for potential investors and stakeholders.