By Maggie Fick and Mariam Sunny (Reuters) -Novo Nordisk said on Thursday it would buy U.S.-based Akero Therapeutics for up to $5.2 billion to gain access to a promising liver disease drug candidate, in the first major deal by the Danish drugmaker's new CEO to spur growth. Mike Doustdar, who took the helm at the Wegovy maker in July, has signaled a focus on new, highly effective obesity and diabetes drugs that can also treat related cardiometabolic conditions such as MASH, rather than expanding into other ...

Acquisition adds potential first- and best-in-class asset, enhancing Novo Nordisk’s portfolio for treatment of MASH, one of the most prevalent obesity related comorbiditiesAkero Therapeutics’s FGF21 analogue efruxifermin is the only treatment to show significant fibrosis regression in phase 2 in patients with compensated cirrhosis (F4)Novo Nordisk to acquire Akero Therapeutics for 54 USD per share (4.7 billion USD) in cash at closing with a contingent value right (CVR) of 6 USD per share (0.5 billion USD) ...

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 ...

Core Insights - Inventiva has made significant progress in its clinical program and financial position during the first half of 2025, particularly in its Phase 3 clinical trial for MASH [2][23] - The company reported revenues of €4.5 million for the first half of 2025, a substantial increase from €41,000 in the same period of 2024 [4][11] - A net loss of €175.9 million was recorded for the first half of 2025, compared to a net loss of €49.0 million in the first half of 2024 [11][12] Financial Performance - Revenues for the first half of 2025 were primarily driven by a €10 million milestone payment from Chia Tai Tianqing Pharmaceutical Group and €5 million in credit notes under a license agreement [5] - Other income decreased to €1.2 million in the first half of 2025 from €2.7 million in the same period of 2024, attributed to changes in R&D tax credit eligibility [6] - Research and development expenses were €44.9 million, down 4% from €46.8 million in the first half of 2024, reflecting a decrease in costs related to discontinued preclinical programs [7] Cash Position - As of June 30, 2025, cash and cash equivalents totaled €146.7 million, including €24.6 million in short-term deposits, with a cash runway projected until the end of Q3 2026 [8][16] - The company generated €104.8 million from financing activities in the first half of 2025, primarily from the second tranche of structured financing [14] Corporate Developments - A leadership transition occurred with the appointment of Jason Campagna as President of R&D and Chief Medical Officer [18] - The company received authorization for a workforce reduction plan, which began implementation in May 2025 [18] - The completion of enrollment for the pivotal Phase 3 clinical trial, NATiV3, was announced on April 1, 2025 [18] Future Outlook - Topline results from the NATiV3 trial are expected in the second half of 2026 [20] - The company plans to raise additional funds for long-term objectives, including potential public offerings or strategic partnerships [17]

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].

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].

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 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]

Leadership Transition - Inventiva announced a leadership transition with the appointment of Jason Campagna, MD, PhD, as President of Research and Development and Chief Medical Officer, and Martine Zimmermann, PharmD, as Executive Vice President of Regulatory Affairs and Quality Assurance [1][2][4] - Dr. Campagna succeeds Pierre Broqua, PhD, who will transition to a consulting role as Scientific Advisor, and Michael Cooreman, MD, who is departing as CMO [2][4] Executive Experience - Dr. Campagna brings extensive expertise in the MASH field, having previously served as CMO at Q32 Bio and MASH Global Program Lead at Intercept Pharmaceuticals [2] - Dr. Zimmermann was most recently Senior Vice President, Head of Regulatory Affairs at Ipsen, where she led the approval of two liver disease drugs [3] Company Focus and Goals - Inventiva is focused on developing oral therapies for metabolic dysfunction-associated steatohepatitis (MASH) and is currently evaluating lanifibranor in the NATiV3 pivotal Phase 3 clinical trial [5][6] - The company is preparing for the readout of the NATiV3 Phase 3 study next year, with potential regulatory approval and commercialization of lanifibranor [4][6]

Core Insights - Altimmune, Inc. announced positive topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), demonstrating significant MASH resolution and weight loss at 24 weeks [2][4][5] Study Results - The Phase 2b trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2/F3, randomized to receive either weekly subcutaneous pemvidutide at 1.2 mg or 1.8 mg doses or placebo for 24 weeks [3][10] - In an intent-to-treat (ITT) analysis, MASH resolution without worsening of fibrosis was achieved in 59.1% and 52.1% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 19.1% for placebo (p< 0.0001) [3][7] - Fibrosis improvement without worsening of MASH was observed in 31.8% and 34.5% of participants treated with pemvidutide 1.2 mg and 1.8 mg, respectively, versus 25.9% for placebo [3][7] - Weight loss at 24 weeks was 5.0% for the 1.2 mg group and 6.2% for the 1.8 mg group, compared to 1.0% in the placebo group (p< 0.001) [3][7] - Liver fat reductions of 58.0% and 62.8% were achieved in participants receiving pemvidutide 1.2 mg and 1.8 mg, respectively, versus 16.2% in the placebo group (p< 0.001) [7][8] Safety and Tolerability - Pemvidutide demonstrated potentially best-in-class tolerability, with less than 1% treatment discontinuations due to adverse events [2][4] - Adverse events leading to treatment discontinuation were 0.0% and 1.2% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared to 2.4% in the placebo group [3][7] Future Outlook - The company anticipates a successful End of Phase 2 meeting with the FDA in the fourth quarter of 2025, enabling rapid progression to Phase 3 [5][4] - The ongoing IMPACT trial is expected to provide a final readout in the fourth quarter of 2025 [10]