Madrigal Pharmaceuticals (NasdaqGS:MDGL) Q3 2025 Earnings Call November 04, 2025 08:00 AM ET Company ParticipantsAkash Tewari - Global Head of Biopharmaceutical ResearchAndrea Newkirk - VP of Biotechnology Equity ResearchBill Sibold - CEOEmma Gutstein - Equity Research AssociateMichael DiFiore - Managing Director of Biotechnology and Pharmaceuticals Equity ResearchMardi Dier - CFOTina Ventura - CIRODavid Soergel - CMO and EVPConference Call ParticipantsRitu Baral - Managing Director and Senior Biotechnology ...

Madrigal Pharmaceuticals (NasdaqGS:MDGL) Q3 2025 Earnings Call November 04, 2025 08:00 AM ET Speaker5Good morning, and thank you for standing by. Welcome to the Madrigal Pharmaceuticals third quarter 2025 earnings conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. As a reminder, today's conference call is being recorded. I'd like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ahea ...

Aligos Therapeutics (NasdaqCM:ALGS) Conference October 21, 2025 07:00 AM ET Company ParticipantsLawrence Blatt - CEOConference Call ParticipantsPatrick Trucchio - Senior Healthcare AnalystPatrick TrucchioHello everyone, and welcome to the first annual H.C. Wainwright Virtual Liver Disease Conference. My name is Patrick Trucchio. I'm a Senior Healthcare Analyst at H.C. Wainwright. This year, for the first time, we've combined our viral hepatitis and MASH conferences, expanding the scope to also include liver ...

Pharma companies are betting big on drugs that treat MASH, a serious liver disease linked to obesity and metabolic issues. Several companies have snapped up experimental drugs this year, including Roach and Novon Nordisk, which uh each have agreed to acquire liver disease focused companies and deals potentially worth several billion dollars a piece. The moves follow successful launch of Magical's drug res, which was the first match drug cleared by the FDA back in March 2024.For more in the increasingly comp ...

The Comprehensive Impact of Lanifibranor: Addressing the Full MASH Spectrum Through Intra - and Extrahepatic Mechanisms of Action October 8, 2025 Property of Inventiva │ Forward Looking Statement This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, included in this presentation are forward-looking statements. Certain of these statements, forecasts and estimates ...

Daix (France), New York City (New York, United States), October 1, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the appointment of Andrew Obenshain as Chief Executive Officer (“CEO”) of the Company. Mr. Obenshain will also join the Company’s Board of Directors. He succeeds Frédéric Cren, th ...

Roche has signed a definitive merger agreement for the acquisition of clinical-stage biopharmaceutical company 89bio, for a total equity value of around $2.4bn. Under the deal, Roche will initiate a tender offer to purchase all outstanding shares of 89bio common stock at $14.50 per share in cash. This will also include a non-tradeable contingent value right (CVR) that could yield payments of up to $6 per share based on specific milestones. The potential total deal value represents up to $3.5bn. The off ...

公司背景 - 公司专注于开发GLP-1胰高血糖素双受体激动剂pemvidutide 用于治疗严重肝脏疾病如MASH [1] - 药物设计兼具肝脏直接作用与代谢益处 通过胰高血糖素直接作用于肝脏 GLP-1成分主要通过减重提供代谢效益 [1][2] 药物机制 - pemvidutide通过胰高血糖素成分实现肝脏直接作用 通过GLP-1成分实现减重等代谢效益 [1][2] - 治疗MASH的最佳方式需同时针对肝脏直接作用和全身代谢改善 [2] 研发重点 - 当前研发聚焦于严重肝脏疾病领域 特别是MASH治疗 [1] - 公司管理层包括首席执行官和首席医疗官共同推进临床开发 [1]

文章核心观点 公司公布2b期NATIVE临床试验和临床前研究结果，显示lanifibranor对治疗代谢功能障碍相关脂肪性肝炎（MASH）和纤维化有潜在益处 [1] 分组1：研究成果 - 2b期NATIVE临床试验结果显示，肝窦内皮细胞（LSEC）毛细血管化与纤维化和炎症阶段相关，lanifibranor可降低这种毛细血管化 [2][3] - 临床前模型显示，疾病早期会出现血管改变，lanifibranor不仅能逆转毛细血管化，还能使肝内血管阻力正常化，效果优于单一PPAR激动剂 [4] - 2b期NATIVE试验组织学评估表明，LSEC毛细血管化发生在疾病早期，结合临床前模型数据，显示lanifibranor作为泛PPAR激动剂有潜在益处 [6] 分组2：lanifibranor介绍 - lanifibranor是公司主要候选产品，是口服小分子药物，可激活三种过氧化物酶体增殖物激活受体（PPAR）亚型，是唯一处于临床开发阶段用于治疗MASH的泛PPAR激动剂 [9] - 其适度平衡的泛PPAR结合特性使其在临床试验和临床前研究中具有良好耐受性，获FDA突破性疗法和快速通道指定 [9] 分组3：公司介绍 - 公司是临床阶段生物制药公司，专注于开发治疗MASH的口服小分子疗法 [10] - 公司正在NATiV3关键3期临床试验中评估lanifibranor治疗成年MASH患者的效果 [10] - 公司在巴黎泛欧证券交易所和美国纳斯达克全球市场上市 [11]

试验结果 - 在IMPACT Phase 2b MASH试验中，1.2 mg pemvidutide组的MASH解决率为66.6%，显著高于安慰剂组的23.2%（p < 0.0001）[16] - 1.8 mg pemvidutide组的MASH解决率为56.0%，同样显著高于安慰剂组（p < 0.0001）[16] - pemvidutide在24周内使肝脂肪含量减少高达62.8%[36] - pemvidutide在24周内的ALT（丙氨酸氨基转移酶）水平显著降低，1.2 mg组和1.8 mg组分别减少34.4 IU/L和34.6 IU/L，均显著优于安慰剂组[40] - 1.2 mg pemvidutide组的纤维化改善率为35.6%，1.8 mg组为37.0%，安慰剂组为30.9%[23] - pemvidutide在24周内的体重减轻分别为1.2 mg组6.2%和1.8 mg组5.0%，均显著高于安慰剂组[44] - 试验中，少于1%的受试者因不良事件停止治疗，显示出良好的耐受性[47] - 1.2 mg和1.8 mg组的严重不良事件发生率分别为2.4%和4.7%，与安慰剂组相当[47] - pemvidutide在24周内的非侵入性纤维化测试显示出显著改善，p < 0.001[32] - 在24周时，试验达成主要终点，MASH（代谢相关脂肪肝病）分辨率的统计显著性达到59.1%[55] - 纤维化改善且MASH无恶化的比例为34.5%[55] - 体重减轻高达6.2%，且在24周时未出现平台期[55] - 服用pemvidutide的受试者中不良事件导致的停药率低于1%[55] 健康指标 - 1.2 mg组收缩压降低6.6 mmHg，1.8 mg组降低5.9 mmHg，均显著优于安慰剂组[51] - 1.2 mg组和1.8 mg组的舒张压分别降低2.4 mmHg和2.8 mmHg[51] - 1.2 mg组心率降低0.7 bpm，1.8 mg组心率增加1.0 bpm[51] - 所有受试者的HbA1c变化为1.2 mg组-0.09%和1.8 mg组-0.12%[50] - HbA1c水平在不同糖尿病状态下保持稳定[55]