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CONSHOHOCKEN, Pa., May 29, 2024 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced ten data presentations at the upcoming European Association for the Study of the Liver (EASL) Congress, taking place from June 5-8, 2024 in Milan, Italy..
宾夕法尼亚州康舍霍肯(CONSHOHOCKEN),2024年5月29日(Global NEWSWIRE)--专注于为非酒精性脂肪性肝炎(NASH)提供新型治疗药物的生物制药公司马德里加制药公司(NASDAQ:MDGL)今天在即将于2024年6月5日至8日在意大利米兰举行的欧洲肝脏研究协会(EASL)大会上宣布了十项数据演示。。
“The data we will be presenting at EASL further support Rezdiffra as the foundational therapy in NASH and Madrigal as the leading company in the field,' said Bill Sibold, Chief Executive Officer of Madrigal. 'We look forward to sharing multiple new data analyses from the MAESTRO Phase 3 program, including the first quality of life data, further analysis of noninvasive test results, and the first look at Rezdiffra in patients with metabolic dysfunction- and alcohol associated liver disease (MetALD).'.
Madrigal首席执行官比尔·西博尔德(BillSibold)说:“我们将在EASL上提供的数据进一步支持Rezdiffra作为纳什和Madrigal的基础疗法,作为该领域的领先公司。我们期待着分享MAESTRO第三阶段计划的多项新数据分析,包括第一次生活质量数据,对无创检测结果的进一步分析,以及对代谢功能障碍和酒精相关性肝病(MetALD)患者的Rezdiffra的首次观察。”。
Mr. Sibold continued, “Additionally, we will be presenting important new real-world data examining the burden of uncontrolled NASH on patients and the health system. The serious human and economic costs of this disease are coming into focus, and we’re learning that patients can progress to cirrhosis and decompensated cirrhosis at a faster rate than previously understood.”.
西博尔德先生继续说,“此外,我们将提供重要的新的现实世界数据,检查不受控制的NASH对患者和卫生系统的负担。这种疾病的严重人力和经济成本正在成为焦点,我们正在了解患者可以比以前理解的更快地发展为肝硬化和失代偿性肝硬化。”。
Rezdiffra is a once-daily, oral, liver-directed thyroid hormone receptor (THR)-β agonist designed to target key underlying causes of NASH. It is the first approved medication for the treatment of NASH. In the pivotal Phase 3 MAESTRO-NASH biopsy trial, Rezdiffra achieved both fibrosis improvement and NASH resolution primary endpoints, and 80% of patients treated with Rezdiffra 100 mg experienced improvement or stabilization of fibrosis.
Rezdiffra是一种每日一次的口服肝脏定向甲状腺激素受体(THR)-β激动剂,旨在针对NASH的关键潜在原因。这是第一种被批准用于治疗NASH的药物。在关键的3期MAESTRO-NASH活检试验中,Rezdiffra实现了纤维化改善和NASH消退的主要终点,80%接受Rezdiffra 100 mg治疗的患者经历了纤维化的改善或稳定。
Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials..
Rezdiffra与饮食和运动一起用于治疗患有中度至晚期肝纤维化(与F2至F3期纤维化一致)的非肝硬化NASH成人。继续批准该适应症可能取决于正在进行的验证性试验中对临床益处的验证和描述。。
Madrigal data presentations at the EASL Congress 2024
2024年EASL大会上的宗教数据展示
Late-breaking oral presentation: “Identification and validation of pre-identified morphological baseline features for prediction of fibrosis progression in MAESTRO-NASH” [Friday, June 7 at 17:45 CEST. Presenter: Jörn Schattenberg]
最新的口头报告:“确定和验证预先确定的形态学基线特征,以预测MAESTRO-NASH的纤维化进展”[6月7日星期五17:45 CEST。主持人:Jörn Schattenberg]
Oral presentation: “Assessment of resmetirom efficacy (80 mg vs. 100 mg) stratified by baseline body mass index and weight in patients from the MAESTRO-NASH trial” [Saturday, June 8 at 11:15 CEST. Presenter: Mazen Noureddin]
口头介绍:“根据MAESTRO-NASH试验患者的基线体重指数和体重分层评估resmetirom疗效(80 mg vs.100 mg)”[6月8日星期六11:15 CEST。主持人:Mazen Noureddin]
Poster: “Health-related quality of life assessments in a 52-week, double-blind, randomized, placebo-controlled Phase 3 study of resmetirom in patients with NASH and fibrosis (MAESTRO-NASH)” [Presenter: Zobair Younossi]
海报:“一项为期52周的、双盲、随机、安慰剂对照的NASH和纤维化患者resmetirom 3期研究中与健康相关的生活质量评估(MAESTRO-NASH)”[主持人:Zobair Younossi]
Poster: “Noninvasive predictive markers of resmetirom biopsy response” [Presenter: Jörn Schattenberg]
海报:“resmetirom活检反应的无创预测标志物”[主持人:Jörn Schattenberg]
Poster: “Resmetirom treatment of a subgroup of patients with possible MetALD enrolled in MAESTRO-NASH, a Phase 3 NASH/MASH serial liver biopsy study” [Presenter: Vlad Ratziu]
海报:“参加MAESTRO-NASH(一项3期NASH/MASH系列肝活检研究)的可能患有MetALD的亚组患者的Resmetirom治疗”[主持人:弗拉德·拉齐奥]
Poster: “Analyses of fibrosis biomarkers PRO-C3 and ELF in resmetirom treated patients from MAESTRO-NASH, a 52 Week NASH/MASH serial liver biopsy study” [Presenter: Quentin Anstee]
海报:“MAESTRO-NASH治疗的患者中纤维化生物标志物PRO-C3和ELF的分析,这是一项为期52周的NASH/MASH系列肝活检研究”[主持人:昆汀·安斯蒂]
Poster: “Using machine learning models to predict baseline fibrosis stage in patients from phase 3 resmetirom trials (MAESTRO-NAFLD and MAESTRO-NASH)” [Presenter: Jörn Schattenberg]
海报:“使用机器学习模型预测3期resmetirom试验(MAESTRO-NAFLD和MAESTRO-NASH)患者的基线纤维化阶段”[主持人:Jörn Schattenberg]
Poster: “Risk of nonalcoholic steatohepatitis disease progression to more severe liver disease in Medicare patients” [Presenter: Robert Gish]
海报:“医疗保险患者非酒精性脂肪性肝炎进展为更严重肝病的风险”[主持人:罗伯特·吉什]
Poster: “Costs associated with nonalcoholic steatohepatitis disease progression in Medicare patients” [Presenter: Robert Gish]
海报:“与医疗保险患者非酒精性脂肪性肝炎疾病进展相关的费用”[主持人:罗伯特·吉什]
Poster: “Healthcare cost and resource utilization among patients with nonalcoholic steatohepatitis, stratified by glucagon-like peptide 1 receptor agonist use in real world data” [Presenter: Yestle Kim]
海报:“非酒精性脂肪性肝炎患者的医疗保健成本和资源利用率,按实际数据中胰高血糖素样肽1受体激动剂的使用分层”[主持人:Yestle Kim]
About the Phase 3 MAESTRO-NASH Trial of Rezdiffra
关于Rezdiffra的MAESTRO-NASH第三阶段试验
MAESTRO-NASH is an ongoing Phase 3 trial that enrolled 1759 patients with biopsy-confirmed NASH. Patients were randomly assigned in a 1:1:1 ratio to receive once-daily Rezdiffra at a dose of 80 mg or 100 mg or placebo. The two primary endpoints at week 52 were NASH resolution with no worsening of fibrosis and an improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score.
MAESTRO-NASH是一项正在进行的3期临床试验,招募了1759名经活检证实的NASH患者。患者以1:1:1的比例随机分配,每天接受一次80 mg或100 mg剂量的Rezdiffra或安慰剂。第52周的两个主要终点是NASH消退,纤维化没有恶化,纤维化至少改善了一个阶段,NAFLD活动评分没有恶化。
The key secondary endpoint was the percent change from baseline in LDL cholesterol at week 24..
关键的次要终点是第24周LDL胆固醇与基线的百分比变化。。
Rezdiffra achieved both primary endpoints and the key secondary endpoint of the MAESTRO-NASH trial. Additionally, Rezdiffra improved liver enzymes, fibrosis biomarkers and imaging tests as compared with placebo. The primary results of the trial were published in the New England Journal of Medicine in February 2024..
Rezdiffra实现了MAESTRO-NASH试验的主要终点和关键次要终点。此外,与安慰剂相比,Rezdiffra改善了肝酶,纤维化生物标志物和成像测试。该试验的主要结果于2024年2月发表在《新英格兰医学杂志》上。。
Patients enrolled in the MAESTRO-NASH trial continue on therapy after the initial 52-week treatment period for up to 54 months to accrue and measure hepatic clinical outcome events including progression to cirrhosis on biopsy and hepatic decompensation events, as well as all-cause mortality. The 54-month outcomes portion of the trial is designed to generate confirmatory data that, if positive, will help verify Rezdiffra’s clinical benefit and may support full approval..
参加MAESTRO-NASH试验的患者在最初的52周治疗期后继续治疗长达54个月,以累积和测量肝脏临床结果事件,包括活检进展为肝硬化和肝失代偿事件,以及全因死亡率。试验的54个月结果部分旨在产生验证性数据,如果阳性,将有助于验证Rezdiffra的临床益处,并可能支持完全批准。。
About NASH
关于纳什
Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality..
非酒精性脂肪性肝炎(NASH)是一种更高级的非酒精性脂肪性肝病(NAFLD)。NASH是导致肝脏相关死亡率的主要原因,也是全球医疗保健系统日益增加的负担。此外,NASH患者,尤其是那些具有更晚期代谢危险因素(高血压,伴随2型糖尿病)的患者,发生不良心血管事件的风险增加,发病率和死亡率增加。。
Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. NASH is rapidly becoming the leading cause of liver transplantation in the U.S.
一旦患者进展为中度至晚期肝纤维化的NASH(与F2至F3期纤维化一致),不良肝脏结局的风险会急剧增加。NASH正在迅速成为美国肝移植的主要原因。
Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during the launch of Rezdiffra..
Madrigal估计,美国约有150万患者被诊断出患有NASH,其中约525000人患有中度至晚期肝纤维化的NASH。Madrigal计划在Rezdiffra推出期间,在肝脏专科医生的护理下,重点关注大约315000名诊断为NASH的中度至晚期肝纤维化患者。。
NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD); NASH was renamed MASH; and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver.
NASH也称为代谢功能障碍相关脂肪性肝炎(MASH)。2023年,全球肝病医学会和患者团体齐聚一堂,对该疾病进行重命名,目的是建立一个肯定的、不带污名的名称和诊断。非酒精性脂肪性肝病(NAFLD)更名为代谢功能障碍相关脂肪性肝病(MASLD);纳什改名为MASH;建立了一个总称脂肪变性肝病(SLD),以捕捉与肝脏脂肪堆积相关的多种类型的肝脏疾病。
In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes)..
除肝病外,MASH患者至少有一种相关的合并症(例如肥胖,高血压,血脂异常或2型糖尿病)。。
About Rezdiffra
关于Rezdiffra
What is Rezdiffra?
雷兹迪夫拉是什么?
Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver.
Rezdiffra是一种处方药,与饮食和运动一起用于治疗成人非酒精性脂肪性肝炎(NASH),伴有中度至晚期肝瘢痕形成(纤维化),但不伴有肝硬化。
It is not known if Rezdiffra is safe and effective in children (under 18 years old).
目前尚不清楚Rezdiffra对儿童(18岁以下)是否安全有效。
This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra.
该适应症是基于NASH和肝瘢痕(纤维化)的改善而批准的。正在进行的研究证实了Rezdiffra的临床益处。
Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you:
服用Rezdiffra之前,请告知您的医疗保健提供者您的所有医疗状况,包括您是否:
have any liver problems other than NASH.
除NASH外,还有其他肝脏问题。
have gallbladder problems or have been told you have gallbladder problems, including gallstones.
有胆囊问题或被告知有胆囊问题,包括胆结石。
are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby.
怀孕或计划怀孕。目前尚不清楚Rezdiffra是否会伤害您未出生的婴儿。
are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra.
正在母乳喂养或计划母乳喂养。目前尚不清楚Rezdiffra是否会进入你的母乳。如果服用Rezdiffra,请与您的医疗保健提供者谈谈喂养宝宝的最佳方法。
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
告诉你的医疗保健提供者你服用的所有药物,包括处方药和非处方药、维生素和草药补充剂。
Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works.
Rezdiffra和其他药物可能会相互影响,产生副作用。Rezdiffra可能会影响其他药物的工作方式,其他药物可能会影响Rezdiffra的工作方式。
Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines.
特别是告诉你的医疗保健提供者,如果你服用含有吉非罗齐的药物来帮助降低甘油三酯,或者服用环孢菌素来抑制你的免疫系统,因为服用这些药物的患者不建议服用雷兹迪夫拉。
Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol.
如果您正在服用氯吡格雷等药物来稀释血液或他汀类药物来帮助降低胆固醇,请告知您的医疗保健提供者。
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
了解你服用的药物。保留一份清单,以便在您获得新药时向您的医疗保健提供者和药剂师展示。
What are the possible side effects of Rezdiffra?
Rezdiffra可能有哪些副作用?
Rezdiffra may cause serious side effects, including:
Rezdiffra可能会引起严重的副作用,包括:
liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen)..
肝损伤(肝毒性)。如果您出现以下肝毒性症状或体征,请停止服用瑞兹迪夫拉,并立即致电您的医疗保健提供者:疲倦、恶心、呕吐、发烧、皮疹、皮肤或眼睛的白色部分变黄(黄疸)、胃中上部或右上部(腹部)疼痛或压痛。。
gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away.
胆囊问题。NASH可能会出现胆囊问题,如胆结石,胆囊炎症或胆结石引起的胰腺炎症,如果服用雷兹迪夫拉可能会出现。如果您出现这些症状的任何体征或症状,包括恶心、呕吐、发烧或胃部(腹部)疼痛严重且不会消失,请立即致电您的医疗保健提供者。
The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting..
从腹部到背部可能会感到疼痛,疼痛可能伴有或不伴有呕吐。。
The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation.
Rezdiffra最常见的副作用包括:腹泻,恶心,瘙痒,胃(腹)痛,呕吐,头晕,便秘。
These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist.
这些并不是Rezdiffra所有可能的副作用。有关更多信息,请咨询您的医疗保健提供者或药剂师。
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Madrigal at 1-800-905-0324.
打电话给你的医生,询问有关副作用的医疗建议。您可以通过1-800-FDA-1088或www.FDA.gov/medwatch向FDA报告副作用。您也可以致电1-800-905-0324向Madrigal报告副作用。
Please see the full Prescribing Information, including Patient Information, for Rezdiffra.
请参阅Rezdiffra的完整处方信息,包括患者信息。
About Madrigal Pharmaceuticals
关于Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), 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 NASH.
Madrigal Pharmaceuticals,Inc.(纳斯达克股票代码:MDGL)是一家生物制药公司,致力于非酒精性脂肪性肝炎(NASH)的新型治疗方法,NASH是一种肝脏疾病,其医疗需求尚未得到满足。Madrigal的药物Rezdiffra(resmetirom)是一种每日一次的口服肝脏导向THR-β激动剂,旨在针对NASH的关键潜在原因。
For more information, visit www.madrigalpharma.com..
For more information, visit www.madrigalpharma.com..
Forward Looking Statements
前瞻性声明
This press release 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.
本新闻稿包括根据1995年《私人证券诉讼改革法案》的安全港条款做出的“前瞻性声明”,这些声明基于Madrigal的信念和假设以及目前可获得的信息,但受到其无法控制的因素的影响。
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 historical facts; statements referenced by forward-looking statement identifiers; and statements regarding: Rezdiffra (resmetirom) and its expected use for treating NASH with moderate to advanced fibrosis; the initiation of the commercial launch of Rezdiffra, including statements regarding commercial insurance and the anticipated time to fill prescriptions; estimates of patients diagnosed with NASH and market opportunities; the relationship between NASH progression and adverse patient outcomes; the estimated clinical burden of uncontrolled NASH; analyses for patients with NASH with moderate to advanced fibrosis concerning potential progression to cirrhosis, decompensated cirrhosis, liver transplant or death; cardiovascular risks, comorbidities and outcomes; health economics assessments or projections; indicating Rezdiffra has been shown to improve the fibrosis that is associated with progression to cirrhosis and its complications and resolve the underlying inflammation that drives the disease; projections or objectives for obtaining full approval for Rezdiffra (resmetirom), including those concerning potential clinical benefit to support potential full approval; regarding post-approval requirements and commitments; reduced risk of progression to cirrhosis, liver failu.
前瞻性陈述反映了管理层对未来业绩或事件的当前知识、假设、判断和期望。前瞻性陈述包括所有非历史事实的陈述;前瞻性声明标识符引用的声明;以及关于以下方面的声明:Rezdiffra(resmetirom)及其用于治疗中度至晚期纤维化的NASH的预期用途;Rezdiffra的商业启动,包括关于商业保险的声明和填写处方的预期时间;估计被诊断患有NASH的患者和市场机会;NASH进展与不良患者结局之间的关系;不受控制的NASH的估计临床负担;分析患有中度至晚期纤维化的NASH患者可能进展为肝硬化,失代偿性肝硬化,肝移植或死亡;心血管风险,合并症和结局;卫生经济学评估或预测;表明Rezdiffra已被证明可以改善与肝硬化进展及其并发症相关的纤维化,并解决驱动疾病的潜在炎症;获得Rezdiffra(resmetirom)完全批准的预测或目标,包括有关潜在临床益处以支持潜在完全批准的预测或目标;关于批准后的要求和承诺;降低进展为肝硬化、肝衰竭的风险。
Forward-looking statements can be identified by terms such as “accelerate,” “achieve,” “allow,” “anticipates,” “appear,” “be,” “believes,” “can,” “confidence,” “continue,” “could,” “demonstrates,” ”design,” “estimates,” “expectation,” “expects,” “forecasts,” “future,” “goal,” “help,” “hopeful,” “inform,” inform,” “intended,” “intends,” “may,” “might,” “on track,” “planned,” “planning,” “plans,” “positions,” “potential,” “powers,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “will achieve,” “will be,” “would” or similar expressions and the negatives of those terms..
前瞻性陈述可以通过“加速”,“实现”,“允许”,“预期”,“出现”,“是”,“相信”,“可以”,“信心”,“继续”,“可以”,“展示”,“设计”,“估计”,“期望”,“期望”,“预测”,“未来”,“目标”,“帮助”,“希望”,“告知”,“告知”,“预期”,“可能”,“可能”,“正在轨道上”,“计划”,“计划”,“计划”,“职位”,“潜力”,“权力”,“预测”,“预测”,“项目”,“寻求”,“应该”,“将会”,“将会实现”,“将会”,“将会”或类似的表达以及这些术语的负面影响。。
Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: the assumptions underlying the forward-looking statements; risks of obtaining and maintaining regulatory approvals, including, but not limited to, potential regulatory delays or rejections; the challenges with the commercial launch of a new product, particularly for a company that does not have commercial experience; risks associated with meeting the objectives of Madrigal’s clinical studies, including, but not limited to Madrigal’s ability to achieve enrollment objectives concerning patient numbers (including an adequate safety database), outcomes objectives and/or timing objectives for Madrigal’s studies; 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; enrollment and trial conclusion uncertainties; market demand for and acceptance of our product; the potential inability to raise sufficient capital to fund ongoing operations as currently planned or to obtain financings on terms similar to those arranged in the past; the ability to service indebtedness and otherwise comply with debt covenants; outcomes or trends from competitive studies; future topline data timing or results; our ability to prevent and/or mitigate cyber-attacks; the timing and outcomes of clinical studies of Rezdiffra (resmetirom); the uncertainties inherent in clinical testing; and uncertainties concerning analyses or assessments outside of a controlled clinical trial.
前瞻性陈述受到许多风险和不确定性的影响,包括但不限于:前瞻性陈述所依据的假设;获得和维持监管批准的风险,包括但不限于潜在的监管延误或拒绝;新产品商业推出的挑战,尤其是对于没有商业经验的公司而言;与实现Madrigal临床研究目标相关的风险,包括但不限于Madrigal实现有关患者人数(包括足够的安全数据库)的登记目标的能力,Madrigal研究的结果目标和/或时间目标;登记的任何延误或失败,以及不良安全事件的发生;与Rezdiffra(resmetirom)行动机制的影响有关的风险;入学和试验结论的不确定性;市场对我们产品的需求和接受程度;可能无法筹集足够的资金,为当前计划的持续运营提供资金,或无法按照类似于过去安排的条款获得融资;偿还债务和遵守债务契约的能力;竞争研究的结果或趋势;未来的topline数据时间或结果;我们预防和/或减轻网络攻击的能力;Rezdiffra(resmetirom)临床研究的时间和结果;临床测试固有的不确定性;以及与对照临床试验之外的分析或评估有关的不确定性。
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, .
不应过度依赖前瞻性声明,因为前瞻性声明仅在做出之日起生效。Madrigal不承担更新任何前瞻性声明以反映新信息的义务。
Investor Contact
投资者联系人
Tina Ventura, Madrigal Pharmaceuticals, Inc., IR@madrigalpharma.com
Tina Ventura,Madrigal Pharmaceuticals,股份有限公司。IR@madrigalpharma.com
Media Contact
媒体联系人
Christopher Frates, Madrigal Pharmaceuticals, Inc., media@madrigalpharma.com
Christopher Frates,Madrigal Pharmaceuticals,Inc。,media@madrigalpharma.com