Full Press Release Details
• Received two new U.S. Rezdiffra®(resmetirom) patents in F2/F3; both patents will be listed in the FDA’s Orange Book
• Received new U.S. resmetirom patent directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c)
CONSHOHOCKEN, Pa., July 13, 2026 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), today announced that the United States Patent and Trademark Office (USPTO) issued three new resmetirom patents.
Bill Sibold, Chief Executive Officer of Madrigal, stated: “Building a robust patent estate is a core pillar of our long-term strategy. It gives us the runway to continue investing in innovation and extend our leadership in MASH. Last year, we secured our pivotal 2045 F2/F3 patent. Today, we're building on that foundation with three additional patents – two that reinforce our protection in F2/F3 and one supporting our potential F4c indication. Together, these patents further strengthen our robust patent estate and reflect our disciplined approach to maximizing the long-term value of Rezdiffra while reinforcing our leadership in MASH.”
• New U.S. Rezdiffra patents in F2/F3 to be listed in FDA’s Orange BookU.S. Patent No. 12,667,575, directed to administering a weight-threshold step-down 60mg or 80mg resmetirom dose for patients with F2/F3 MASH also using a moderate CYP2C8 inhibitor. This patent issued on June 30, 2026, and is expected to provide protection to 2045.U.S. Patent No. 12,661,359, directed to the administration of rosuvastatin and resmetirom and limits the daily dose of rosuvastatin to a maximum of 20mg per day to reduce or eliminate dose-related side effects. This patent issued on June 23, 2026, and is expected to provide protection to 2042.
• New U.S. resmetirom patent in F4cU.S. Patent No. 12,661,361, directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c). This patent issued on June 23, 2026, and is expected to provide protection to 2042.
• U.S. Patent No. 12,667,575, directed to administering a weight-threshold step-down 60mg or 80mg resmetirom dose for patients with F2/F3 MASH also using a moderate CYP2C8 inhibitor. This patent issued on June 30, 2026, and is expected to provide protection to 2045.
• U.S. Patent No. 12,661,359, directed to the administration of rosuvastatin and resmetirom and limits the daily dose of rosuvastatin to a maximum of 20mg per day to reduce or eliminate dose-related side effects. This patent issued on June 23, 2026, and is expected to provide protection to 2042.
• U.S. Patent No. 12,661,361, directed to a method of administering resmetirom to treat well-compensated cirrhosis (F4c). This patent issued on June 23, 2026, and is expected to provide protection to 2042.
About 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-β agonist designed to target key underlying causes of MASH. Rezdiffra was the first 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, visitwww.madrigalpharma.com.
Forward-Looking StatementsThis press release includes “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended, including statements related to the expected benefit of the new patents and resmetirom’s potential benefit in patients with compensated MASH cirrhosis. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; our ability to successfully commercialize Rezdiffra in the U.S. and Europe; risks related to obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; our history of operating losses and the possibility that we may never achieve or maintain profitability; risks associated with meeting the objectives of our clinical trials, including, but not limited to our ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for our trials; any delays or failures in enrollment, and the occurrence of adverse safety events; risks related to the effects of Rezdiffra’s (resmetirom’s) mechanism of action or of any other product candidate; market demand for and acceptance of Rezdiffra; our ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitors; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; our ability to protect our intellectual property rights; the uncertainties inherent in clinical testing; uncertainties concerning analyses or assessments outside of a controlled clinical trial; and changes in laws and regulations applicable to our business and our ability to comply with such laws and regulations. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s submissions filed with the U.S. Securities and Exchange Commission (SEC) for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied. Madrigal specifically discusses these risks and uncertainties in greater detail in the sections appearing in Part 1A of its Annual Report on Form 10-K for the year ended December 31, 2025, and as updated from time to time by Madrigal’s other filings with the SEC.