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Madrigal Pharmaceuticals to Participate in the TD Cowen 46th Annual Health Care Conference
Globenewswire· 2026-02-24 13:00
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 both the FDA and European Commission for treating MASH with moderate to advanced fibrosis (F2 to F3) [2] - An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [2] Upcoming Events - The company will participate in the TD Cowen 46th Annual Health Care Conference on March 3, 2026, at 2:30 P.M. ET, with a live webcast available for access [1]
Madrigal Q4 Earnings Miss, MASH Drug Sales Drive Top Line, Stock Down
ZACKS· 2026-02-20 16:01
Core Insights - Madrigal Pharmaceuticals (MDGL) reported a Q4 2025 loss of $2.57 per share, significantly missing the Zacks Consensus Estimate of earnings of 4 cents, primarily due to a sharp increase in operating expenses [1][6] - The company generated total revenues of $321.1 million in Q4 2025, driven entirely by product sales of its MASH drug Rezdiffra, surpassing the Zacks Consensus Estimate of $313 million [2][6] - Madrigal shares fell by 11.1% following the mixed earnings results, which did not meet investor expectations [3] Financial Performance - In Q4 2025, research and development expenses surged to $116.3 million, more than quadrupling from previous levels, mainly due to upfront payments for business development transactions [5] - Selling, general and administrative expenses nearly doubled to $240 million, attributed to increased commercial launch activities for Rezdiffra [7] - For the full year 2025, Madrigal recorded total revenues of $958.4 million, all from Rezdiffra sales, exceeding the Zacks Consensus Estimate of $950.8 million [8] Product and Market Updates - Rezdiffra received accelerated approval from the FDA and EU as the first therapy for MASH, targeting adults with noncirrhotic MASH with moderate to advanced liver fibrosis [4][9] - The drug's commercial launch has been strong, with over 36,250 patients receiving treatment by the end of 2025, up from over 29,500 at the end of Q3 2025 [4] - Ongoing studies, including the pivotal phase III MAESTRO-NASH biopsy study, aim to provide long-term safety and efficacy data to support full approval for Rezdiffra [11][12] Pipeline Developments - A second phase III outcomes study (MAESTRO-NASH OUTCOMES) is evaluating Rezdiffra's effectiveness in patients with compensated MASH cirrhosis, with top-line data expected in 2027 [12] - Positive two-year data from the open-label extension of the MAESTRO-NAFLD-1 study supports Rezdiffra's potential benefits for patients with compensated MASH cirrhosis [13]
Madrigal Pharmaceuticals(MDGL) - 2025 Q4 - Earnings Call Presentation
2026-02-19 13:00
4Q25 Financial Results Feb. 19, 2026 NASDAQ: MDGL © 2026 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, assumpt ...
Madrigal Pharmaceuticals Reports Fourth-Quarter and Full-Year 2025 Financial Results
Globenewswire· 2026-02-19 12:00
Core Insights - Madrigal Pharmaceuticals, Inc. has established itself as a leader in the MASH market, achieving nearly $1 billion in Rezdiffra sales in its first full year of launch, with expectations for continued growth in 2026 driven by increased market penetration and disease awareness [2][5]. Financial Performance - Fourth-quarter 2025 net sales for Rezdiffra reached $321.1 million, while full-year sales totaled $958.4 million, a significant increase from $103.3 million and $180.1 million in the prior year periods [5][8]. - Operating expenses for the fourth quarter and full year were $380.7 million and $1,258.5 million, respectively, compared to $170.3 million and $678.0 million in the previous year [8][19]. - The company reported a net loss of $58.6 million for the fourth quarter and $288.3 million for the full year, with basic and diluted net loss per share of $2.57 and $12.85, respectively [19]. Pipeline and Product Development - Madrigal has built an industry-leading MASH pipeline with over 10 programs at various stages of development, including licensed global rights to six pre-clinical siRNA programs aimed at genetically targeted treatments [5][6]. - The company has expanded its pipeline with an exclusive global license for ervogastat, a phase 2 oral DGAT-2 inhibitor, which has shown promising results in reducing liver fat in patients [6][7]. - MGL-2086, an oral GLP-1 receptor agonist, is expected to enter clinical trials in the second quarter of 2026, further enhancing the company's combination treatment strategy [9]. Market Position and Strategy - Madrigal's Rezdiffra is the first and only approved therapy for MASH in the European Union, following its launch in Germany after receiving conditional marketing authorization [9][10]. - The company has secured a patent for Rezdiffra that extends protection until 2045, reinforcing its competitive position in the market [6][7]. - Madrigal aims to address the needs of approximately 315,000 patients with moderate to advanced fibrosis in the U.S., highlighting the significant market opportunity as disease awareness and prevalence increase [12][13].
Ribo and Ribocure Announce Exclusive Global Licensing Agreement with Madrigal for Novel siRNA Therapeutics Targeting MASH
Prnewswire· 2026-02-11 11:25
Core Insights - Ribo Life Science and Ribocure Pharmaceuticals have entered into an exclusive global licensing agreement with Madrigal Pharmaceuticals for six pre-clinical siRNA programs targeting metabolic dysfunction-associated steatohepatitis (MASH) [1] - The collaboration will leverage Ribo's GalSTARTM platform to develop novel treatments for MASH, with options to expand into new siRNA programs [1] - Ribo will receive an upfront payment of US$60 million, with potential cumulative payments reaching US$4.4 billion based on milestone achievements, along with royalties on net sales [1] Company Overview - Suzhou Ribo Life Science Co., Ltd. is focused on developing nucleic acid drugs based on RNA interference technology, with a strong product pipeline aimed at addressing serious diseases with unmet medical needs [1] - Ribocure Pharmaceuticals, a subsidiary of Ribo, is dedicated to the global development of life-saving oligonucleotide therapies and innovative capacities for clinical trials [1] 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 [1] - The prevalence of MASH is increasing, with a significant rise in diagnosed patients expected, particularly those with moderate to advanced fibrosis [1] - Madrigal Pharmaceuticals has developed Rezdiffra, the first medication approved for treating MASH with moderate to advanced fibrosis, highlighting the high unmet medical need in this area [1]
Madrigal Expands its MASH Pipeline with Exclusive Global Licensing Agreement for Six Preclinical siRNA Programs
Globenewswire· 2026-02-11 10:00
Core Viewpoint - Madrigal Pharmaceuticals has entered an exclusive global license agreement with Suzhou Ribo Life Science for six preclinical small interfering RNA (siRNA) programs aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) [1][6] Company Overview - Madrigal Pharmaceuticals is focused on developing novel therapeutics for MASH, a liver disease with significant unmet medical needs [14] - The company’s lead product, Rezdiffra (resmetirom), is the first medication approved for MASH with moderate to advanced fibrosis [14] - Madrigal's pipeline now includes over 10 programs targeting various drivers of MASH, with Rezdiffra serving as the foundational therapy [2][3] Research and Development Strategy - The R&D strategy emphasizes innovative compounds targeting validated mechanisms of disease to improve patient outcomes [2] - siRNAs are highlighted for their precision in gene silencing, potentially complementing the effects of Rezdiffra [3][5] - The company plans to initiate IND-enabling activities for initial siRNA candidates in 2026 [5] Financial Aspects - Ribo will receive an upfront payment of $60 million, with potential cumulative payments reaching $4.4 billion based on milestone achievements, in addition to royalties on net sales [6] Market Context - MASH is a leading cause of liver transplantation, particularly among women, and is rapidly growing in prevalence [7][9] - Patients with moderate to advanced liver fibrosis face significantly higher risks of liver-related mortality, underscoring the urgency for effective treatments [8] Product Information - Rezdiffra is prescribed alongside diet and exercise for adults with MASH and is currently undergoing studies to confirm its clinical benefits [10]
Madrigal Pharmaceuticals to Release Fourth-Quarter and Full-Year 2025 Financial Results and Host Webcast on February 19, 2026
Globenewswire· 2026-02-02 13:05
Core Viewpoint - Madrigal Pharmaceuticals, Inc. is set to release its fourth-quarter and full-year 2025 financial results on February 19, 2026, prior to the opening of U.S. financial markets [1] 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 [3] - The company's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist aimed at addressing key underlying causes of MASH [3] - Rezdiffra is the first and only medication approved by both the FDA and European Commission for treating MASH with moderate to advanced fibrosis (F2 to F3) [3] - An ongoing Phase 3 outcomes trial is currently evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c) [3]
Madrigal Pharmaceuticals Announces Grant of Inducement Award under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2026-01-21 21:05
Core Insights - Madrigal Pharmaceuticals, Inc. has granted an equity award to Rita Thakkar, the new Chief Accounting Officer, as part of its 2025 Inducement Plan [1][2] - The equity award includes 2,398 time-based restricted stock units and options to purchase 1,826 shares of common stock, with an exercise price of $495.88 per share [2] - Madrigal focuses on developing therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), with its medication Rezdiffra being the first approved treatment for MASH with moderate to advanced fibrosis [3] Group 1 - The equity award was approved by Madrigal's Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4) [1] - Options vesting schedule includes 25% on the first anniversary and 6.25% quarterly thereafter, while restricted stock units vest in four equal installments over four years [2] - Rezdiffra is a once-daily, oral, liver-directed THR-β agonist targeting key causes of MASH, with ongoing trials for compensated MASH cirrhosis [3]
Madrigal Pharmaceuticals (NasdaqGS:MDGL) FY Earnings Call Presentation
2026-01-12 21:30
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 regarding future performance or events. Forward-looking statements include all statements that are not h ...
MDGL Secures Exclusive Global Right for MASH Treatment From PFE
ZACKS· 2026-01-12 17:20
Core Insights - Madrigal Pharmaceuticals has acquired exclusive global rights to ervogastat from Pfizer, enhancing its pipeline for metabolic dysfunction-associated steatohepatitis (MASH) [1][6] - Ervogastat is a mid-stage, oral DGAT-2 inhibitor that reduces liver triglyceride levels and inflammation [1][5] - Madrigal's shares have increased by 69.3% over the past year, significantly outperforming the industry growth of 4.6% [1] Company Developments - The acquisition of ervogastat aims to develop combination therapies with Madrigal's approved therapy, Rezdiffra, to improve clinical outcomes and commercial potential for MASH treatment [3][6] - Rezdiffra is already approved in the U.S. for adult patients with noncirrhotic MASH with moderate-to-advanced liver fibrosis [4][7] Clinical Efficacy - In a phase II study, ervogastat showed significant efficacy, with 72% of patients achieving a 30% reduction in liver fat and 61% achieving a 50% reduction [5][6] - The treatment was well tolerated, and improvements in liver enzymes and stiffness were observed [5] Future Plans - Madrigal plans to conduct a drug-to-drug interaction study with Rezdiffra and consult the FDA for a phase II combination study [7][8] - The combination of ervogastat and Rezdiffra is expected to provide greater benefits due to their distinct mechanisms [8] Financial Aspects - Madrigal will make a $50 million upfront payment to Pfizer, with additional milestone and royalty payments contingent on successful development and commercialization of ervogastat [9]