Exhibit 99.1 Madrigal Pharmaceuticals Provides Corporate Updates and Reports Fourth Quarter and Full Year 2023 Financial Results • Announced appointment of Mardi C. Dier as Chief Financial Officer • Anticipates resmetirom to become the first medicine approved for NASH; PDUFA date March 14, 2024 • Reports year-end 2023 cash, cash equivalents and marketable securities of $634 million CONSHOHOCKEN, PA, February 28, 2024 – Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company ...

公司概况 - 公司总部位于宾夕法尼亚州的West Conshohocken，成立于2011年[3] 知识产权 - 公司拥有或共同拥有7项美国和44项外国已颁发专利，以及9项美国和70项外国待定专利申请[1] FDA监管 - 美国食品药品监督管理局（FDA）对药物进行严格监管，新药必须通过新药申请（NDA）流程获得批准后才能在美国合法上市[2] - 临床试验必须在符合GCP的情况下进行，必须提交给FDA作为IND的一部分，并且必须在每个机构的IRB批准下进行[3] - FDA对NDA进行审查，以确定产品是否适合其预期用途，并且其制造是否符合cGMP以确保产品的身份、强度、质量和纯度[1] - FDA审批过程中可能会发出批准信或完整回复信，后者通常概述提交中的不足，并可能要求额外的临床或其他数据[2] - 优先审查的NDA意味着FDA将在NDA被接受提交后的六个月内审查NDA[2] - 21 CFR第314部分H加速批准路径要求在获得加速批准后进行确认性的充分和良好控制的后市场临床试验[2] - 加速批准不会改变批准标准，但可能加快批准过程[2] - FDORA要求FDA在加速批准日期之前指定后市场研究的条件[3] - 加速批准赞助商必须每六个月提交后市场试验的进展报告[3] - FDASIA使儿童最佳药物法案永久化，为在FDA的书面请求下对儿童进行临床试验提供额外六个月的市场独占权[1] - FDA维护多个计划以促进和加快治疗严重或危及生命疾病的药物申请的发展和审查[2] - FDA可能会撤销批准，如果产品在市场上出现安全或有效性问题[3] 法规影响 - 未来立法可能会显著改变FDA监管产品批准、生产和营销的法定规定[4] - 欧洲药品临床试验规定的变化对公司的产品开发和市场准入产生影响[3] - 欧洲药品市场授权制度的变化可能延迟竞争对手仿制产品上市[4] - 美国和欧洲的医疗保健改革对公司产品的定价和市场准入带来不确定性[1] - 美国医疗保健改革法案对药品定价和市场准入产生影响[2] 政府医疗保健计划 - 政府对药品价格和医疗保健费用的控制可能影响公司产品的销售和盈利[5] - 政府医疗保健计划的改革可能限制公司产品的定价和市场准入[6] - 政府医疗保健计划的改革可能导致公司产品的销售收入受到负面影响[7] - 政府医疗保健计划的改革可能对公司产品的市场机会和收入产生限制[8] - 政府医疗保健计划的改革可能导致公司产品的定价受到限制[9] 财务管理 - 公司投资组合主要包括高质量的金融工具，如货币市场基金、美国政府和机构债券，有效期少于12个月，没有超过24个月的证券[3] - 公司目前没有对利率风险进行对冲，认为利率立即变动10%不会对投资组合的公允市场价值产生重大影响[3] - 公司目前没有产品收入，依赖通过其他途径筹集资金，包括未来的债务或股本发行[4] - 通货膨胀对公司业务、财务状况或运营结果没有产生重大影响[5] - 公司管理层认为内部财务报告控制有效，符合2013年框架的标准[3] - 公司管理层评估了内部财务报告控制的有效性，并得出结论认为截至2023年12月31日有效[3] - 公司内部财务报告控制在2023年12月31日没有发生重大影响或可能发生重大影响的变化[4] - 公司的董事和高管采纳了10b5-1计划，涉及Madrigal普通股的销售[5]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 MADRIGAL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 MADRIGAL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3508648 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 MADRIGAL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3508648 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-33277 MADRIGAL PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 04-3508648 (State or other juri ...

Corporate Presentation May 2022 Resmetirom is an investigational therapy and has not been approved by the FDA (or any other regulatory authority). Resmetirom is only available for use in a clinical trial setting (ClinicalTrials.gov NCT03900429, NCT04197479). NASDAQ: MDGL © 2022 Madrigal Pharmaceuticals. All rights reserved. Forward Looking Statements This communication contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, t ...

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) Q1 2022 Results Earnings Conference Call May 9, 2022 8:00 AM ET Company Participants Paul Friedman - Chairman and Chief Executive Officer Rebecca Taub - Founder, Chief Medical Officer and President of Research & Development Remy Sukhija - Chief Commercial Officer Alex Howarth - Chief Financial Officer Stephen Harrison - M.D., Medical Director, Pinnacle Clinical Research Conference Call Participants Ritu Baral - Cowen Thomas Smith - SVB Securities Yasmeen Rahimi - ...

Resmetirom AASLD Clinical Data Review Tuesday, November 16th, 2021 8.00 – 9.00am EST Forward Looking Statements Any statements, other than statements of historical facts, made in this presentation are, or may be deemed, forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include those concerning: our primary and secondary study endpoints and supportive data for resmetirom, and the potential for achieving such end ...

Product Theater : "Resmetirom for the Treatment of NASH: Early Data from the Phase 3 MAESTRO Clinical Trials." Dr. Stephen Harrison, M.D., Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University, and Principal Investigator of the MAESTRO studies AASLD 2020 Conflicts Advisory Board/Panel: Akero, Altimmune, Arrowhead, Axcella, Blade Therapeutics, Cirius, Civi Biotherma, CLDF, Cymabay, Echosens, Foresite Labs, Galectin, Galmed, Gelesis, Genfi ...