CONSHOHOCKEN, Pa., July 25, 2025 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL), a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), announced today that it will release its second-quarter 2025 financial results on Wednesday, Aug. 5, 2025, prior to the open of the U.S. financial markets. Following the announcement, Madrigal’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s fina ...

Key Takeaways MDGL rose 10.9% as a new U.S. patent is set to protect Rezdiffra's FDA-approved dosing regimen. The patent, valid through 2044, will be listed in the FDA's Orange Book, blocking generic competition. Over 17,000 patients are already on Rezdiffra as MDGL expands clinical data to support full approval.Madrigal Pharmaceuticals (MDGL) shares soared 10.9% on Wednesday. The uptrend was observed after the U.S. Patent and Trademark Office issued a Notice of Allowance for a new U.S. patent related to ...

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]

证券研究报告 | 公司动态点评 2025 年 07 月 11 日 福瑞股份（300049.SZ） MASH 新药上市进程加快，看好诊断设备持续放量 | 财务指标 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业收入（百万元） | 1,154 | 1,349 | 1,727 | 2,457 | 3,629 | | 增长率 yoy（%） | 14.4 | 16.9 | 28.0 | 42.3 | 47.7 | | 归母净利润（百万元） | 102 | 113 | 188 | 290 | 462 | | 增长率 yoy（%） | 3.8 | 11.5 | 65.8 | 54.4 | 59.4 | | ROE（%） | 9.6 | 9.2 | 12.7 | 16.9 | 21.1 | | EPS 最新摊薄（元） | 0.38 | 0.43 | 0.71 | 1.09 | 1.74 | | P/E（倍） | 98.7 | 88.5 | 53.4 | 34.6 | 21.7 | | P/B（倍） | 6 ...

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]

撰文丨王聪 编辑丨王多鱼 排版丨水成文 随着肥胖症、糖尿病及其他代谢综合征的日益普遍， 代谢功能障碍相关脂肪性肝炎 （MASH） 的发病率也在上升。目前，全球约有 1 亿人患有 MASH，预计到 2030 年，这一数字将达到 3.57 亿。 MASH 是肝硬化、肝细胞癌进展的关键因素，也是导致肝移植的主要原因。尽管饮食和运动等生活方式的改变是治疗 MASH 的主要手段，但对大多数患者而言， 通过减重实现逆转颇具挑战性。迄今为止，美国 FDA 仅批准了一款药物 Resmetirom 用于 MASH 的治疗，因此，迫切需要确定新的药物靶点并开发出有效的治 疗手段来应对患者群体庞大且日益增长的 MASH。 2025 年 6 月 30 日，江苏大学 严永敏 团队在 Cell 子刊 Cell Biomaterials 上发表了题为 ： Oral administration of DSPE-PEG-cholic acid-modified ACDVs loaded with siLIMA1 for anti-MASH therapy 的研究论文。 该研究提出了一种大规模获取 人工细胞来源囊泡 （ACDV） 的新策略， ...

VK2735 (GLP-1/GIP Dual Agonist) for Obesity - The VENTURE Phase 2 obesity study achieved its primary endpoint, demonstrating a significant reduction in body weight after 13 weeks of treatment[7, 43] - In the VENTURE study, patients receiving VK2735 experienced up to a 14.7% reduction in body weight from baseline after 13 weeks[44, 61] - Up to 88% of patients in the VENTURE study experienced ≥10% weight loss at the 15mg dose after 13 weeks[50, 51] - Oral VK2735 Phase 1 study showed a dose-dependent reduction in body weight, with a significant reduction of 5.3% versus placebo at the highest dose after 28 days[74, 97] - The company plans to initiate a Phase 2 trial for oral VK2735 in obesity in the second half of 2024[7, 98] VK2809 (Selective Thyroid Receptor-β Agonist) for NASH/MASH - The VOYAGE Phase 2b trial achieved its primary endpoint, demonstrating a robust reduction in liver fat[7, 125] - In the VOYAGE study, patients experienced up to a 55% median reduction in liver fat at 12 weeks[113, 114] - Up to 85% of VK2809 patients experienced a response, defined as a ≥30% decrease in liver fat at Week 12 in the VOYAGE study[116, 117] VK0214 (Selective Thyroid Receptor-β Agonist) for X-ALD - VK0214 Phase 1 study demonstrated LDL-C reductions, with data indicating approximately a 20% reduction from baseline[136, 137] - A Phase 1b study of VK0214 in patients with X-linked adrenoleukodystrophy is ongoing, with data expected in the second quarter of 2024[7] Financial Status - As of December 31, 2023, the company's cash and short-term investments totaled $362.079 million[141] - The company's cash burn year-to-date as of December 31, 2023, was $76.835 million[141] - A follow-on offering in the first quarter of 2024 yielded gross proceeds of $630 million[141]

Core Insights - Inventiva, a clinical-stage biopharmaceutical company, announced the publication of results from the Phase 2b NATIVE clinical trial and preclinical study on lanifibranor for treating metabolic dysfunction-associated steatohepatitis (MASH) [1][10] Group 1: Clinical Trial Results - The Phase 2b NATIVE trial demonstrated that lanifibranor can reduce liver sinusoidal endothelial cell (LSEC) capillarization, which is associated with fibrosis and inflammation in patients with MASH [2][3] - CD34 staining in liver biopsies indicated a higher density in patients with MASLD or MASH compared to those without, and treatment with lanifibranor for 24 weeks resulted in a dose-dependent reduction in CD34 staining [3][6] - Histological evaluations showed that LSEC capillarization occurs early in the disease, suggesting that lanifibranor may help prevent progression to cirrhosis [6][7] Group 2: Mechanism of Action - Lanifibranor acts as a pan-PPAR agonist, targeting all three PPAR isoforms, which may contribute to its anti-fibrotic and anti-inflammatory effects [9] - Preclinical models indicated that lanifibranor not only reverses capillarization but also normalizes intrahepatic vascular resistance and portal vein pressure, outperforming single PPAR agonists [4][7] Group 3: Company Overview - Inventiva is focused on developing oral therapies for MASH and is currently evaluating lanifibranor in the pivotal Phase 3 NATiV3 clinical trial [10] - The FDA has granted Breakthrough Therapy and Fast Track designations to lanifibranor, highlighting its potential in treating MASH [9]

Core Insights - Altimmune, Inc. released topline results from the IMPACT Phase 2b trial of pemvidutide for metabolic dysfunction-associated steatohepatitis (MASH), a severe liver disease [1] Group 1: Trial Details - The Phase 2b trial included 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 [2] - Treatment discontinuation rates were low, with only 9% of participants prematurely discontinuing treatment [3] Group 2: Efficacy Results - In an intent-to-treat (ITT) analysis, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% for pemvidutide 1.2 mg, 52.1% for 1.8 mg, and 19.1% for placebo (p< 0.0001 for both doses) [3] - The effects on fibrosis improvement without worsening of MASH were 31.8% for pemvidutide 1.2 mg, 34.5% for 1.8 mg, compared to 25.9% for placebo, although these differences were not statistically significant [4] Group 3: Analyst Ratings - HC Wainwright reiterated a Buy rating for Altimmune with a price forecast of $12, believing the data supports advancing pemvidutide to Phase 3 and strengthens its case as a potential best-in-class therapy [5] - Conversely, William Blair maintained a Market Perform rating, citing "underwhelming" results and concerns about demonstrating significant fibrosis improvement at the 48-week mark [6] Group 4: Stock Performance - ALT stock is trading lower by 1.80% to $3.545 at last check [7]

整理 | GLP1减重宝典内容团队 Altimmune, Inc.公司今日公布了其候选药物pemvidutide在代谢相关脂肪性肝炎（MASH）治疗中IMPACT 2b期临床试验的积极初步结 果。然而，其疗效令投资人失望，股价一夜之间腰斩。 | 3.610+ | 最 昌 | 3.830 今 开 | 2.98 | | --- | --- | --- | --- | | -4.100 -53.18% | 最 低 | 2.900 昨 收 | 7.71 | | 成交额 3.05亿 市盈率TTM | | 亏损 总市值 → | 2.931 | | 成交量 8611.55万股 市盈率(静) | | 亏损 总股本 | 81117 | | 107.07% 市净率(1) 换手率 | | 2.06 流通值 | 2.901 | | 52周最高 11.160 委 比 | | 59.32% 流通股 | 80437 | | 52周最低 2.900 量 比 | | 14.72 振 幅 | 12.069 | | 历史最高 978.000 股息TTM | | -- 平均价 | 3.54 | | 历史最低 -1731.000 股息率TTM | N ...