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SC 13D/A  Documents [Amend] General statement of acquisition of beneficial ownership
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2020-09-08 005-82674
201162824
4  Documents Statement of changes in beneficial ownership of securities
Acc-no: 0000899243-20-024411 Size: 15 KB
2020-09-04
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2020-09-04
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2020-08-19
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2020-08-19
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Acc-no: 0000899243-20-021949 Size: 5 KB
2020-08-10
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Acc-no: 0001193125-20-211413 (34 Act)  Size: 226 KB
2020-08-06 001-33277
201080106
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Acc-no: 0001193125-20-211214 (34 Act)  Size: 3 MB
2020-08-06 001-33277
201079616
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2020-06-18 001-33277
20971302
4  Documents Statement of changes in beneficial ownership of securities
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2020-06-18
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Related news from
Thu, 03 Sep 2020
10:50:00 +0000
Madrigal Pharmaceuticals Exceeds Target Enrollment in Phase 3 MAESTRO NAFLD-1 Trial
\--Completion of enrollment in MAESTRO-NAFLD-1 will enable reporting of topline 52-week data by the end of next year as planned. \--Madrigal intends to present selected data from ongoing open label arm by the end of 2020 \--Recent presentations at EASL Digital ILC of secondary analysis of Ph2 data demonstrated that reduction in MRI-PDFF can predict improvement in all components of histologic response in NASH, including steatosis, ballooning, inflammation and fibrosis. CONSHOHOCKEN, Pa., Sept. 03, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that it has already exceeded the originally targeted enrollment of 700 patients in its MAESTRO NAFLD-1 clinical trial of resmetirom in patients with NASH and fibrosis that is diagnosed using non-invasive assessments. Resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective thyroid hormone receptor (THR) agonist currently in Phase 3 development for the treatment of NASH patients with fibrosis stage 2-3 (ClinicalTrials.gov NCT03900429 and ClinicalTrials.gov/NCT04197479). MAESTRO-NAFLD-1, was originally planned to enroll 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo, and included an 100 mg resmetirom open label arm in up to 100 patients.  MAESTRO-NAFLD-1 enrollment has already exceeded the enrollment targets in the three double-blinded arms and in the open label arm. Although new screening of patients for the double-blind arms has ended, eligible patients who have already screened for the study will continue to enroll over the next few weeks.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 commented, “MAESTRO-NAFLD-1 has exceeded expectations in terms of enrollment, even during the COVID pandemic, that attests to the high prevalence of NASH and the enthusiasm of patients and investigators to participate in a Phase 3 clinical trial in which the NASH diagnosis is made without a liver biopsy. The ultimate goals of the biomarker tests and liver imaging, which have expanded rapidly in the past few years, are to diagnose NASH with fibrosis non-invasively in order to identify patients with high risk fatty liver disease.”“We are pleased to have achieved our target enrollment in the MAESTRO-NAFLD-1 trial,” stated Paul Friedman, M.D., Madrigal’s Chief Executive Officer.  “We plan to complete enrollment in the double-blind arms of this study near the beginning of October to enable us to report topline 52-week data by the end of next year as planned. We intend to present data from the ongoing open label arm before the end of 2020.”Becky Taub, M.D., Chief Medical Officer and President of Research & Development of Madrigal, stated, “We are encouraged by patient participation in our Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 studies of resmetirom, a once daily oral medication.  We recently began and will continue to enroll patients with compensated NASH cirrhosis into the open label arm of MAESTRO-NAFLD-1 to collect exploratory efficacy and safety data in this important population.  We believe the data from additional enrolled NASH patients in the double-blind arms and patients with NASH cirrhosis will reinforce the safety and efficacy of resmetirom and provide an even more robust safety data base for our Phase 3 NASH program.”Dr. Taub continued, “As we have recently reported, including in presentations by NASH experts over the past week at the Digital International Liver Congress™ 2020 (EASL), secondary analyses of data from our Phase 2 NASH study demonstrate that liver fat reduction at three months after starting treatment has clear predictive power for NASH resolution and fibrosis reduction on subsequent liver biopsy.  Further, once daily oral 80 mg and 100 mg Phase 3 doses of resmetirom deliver at least 50% reduction in liver fat, and, based on secondary analyses of Phase 2 data, are associated with a statistically significant reduction in all components of NASH, including 64% NASH resolution (p<0.0001), of which >60% had fibrosis reduction.  Finally, data from these analyses demonstrate that resmetirom robustly and statistically significantly (p<0.001) reduces markers of net collagen deposition in the liver, supporting the anti-fibrotic action of resmetirom.  The related presentations by NASH experts at EASL are available here: EASL Presentations by NASH Experts_August 2020.”About Resmetirom (MGL-3196) Thyroid hormone, through activation of its β-receptor in hepatocytes, plays a central role in liver function impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Thyroid hormone receptor (THR)-β action in the liver is key to proper function of the liver, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. Patients with NASH have reduced levels of thyroid hormone activity in the liver with resultant impaired hepatic function, in part due to the inflamed state of the liver that causes degradation of thyroid hormone.To exploit the thyroid hormone receptor (THR)-β pathway for therapeutic purposes in cardio-metabolic and liver diseases, it is important to avoid activity at the THR-α receptor, the predominant systemic receptor for thyroid hormone that is responsible for activity outside the liver including in heart and bone.  The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Resmetirom has been shown to be highly selective based on 1) THR- β receptor functional selectivity based on both in vitro and in vivo assays 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver. In short and long term human and animal studies, resmetirom has been confirmed to be safe and devoid of activity at the THR-α receptor and without impact on bone or cardiac parameters. Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist.About the Phase 3 Registration Program for the Treatment of NASH (Non-alcoholic steatohepatitis) Analyses from the resmetirom Phase 2 NASH study demonstrate that the magnitude of liver fat reduction accurately predicts NASH resolution and liver fibrosis reduction and, specifically, that the resmetirom doses being used in Madrigal’s Phase 3 MAESTRO-NASH trial could achieve the level of fat reduction predictive of NASH resolution and fibrosis reduction [Madrigal COVID and ABSTRACT Press Release_20200414].The Phase 3 MAESTRO-NASH trial is expected to enroll 900 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. After 52 weeks of treatment a second biopsy is performed. The primary surrogate endpoint on biopsy will be NASH resolution, with at least a 2-point reduction in NAS (NASH Activity Score), and with no worsening of fibrosis. Two key secondary endpoints are liver fibrosis improvement of at least one stage, with no worsening of NASH, and lowering of LDL-cholesterol [ClinicalTrials.gov/NCT03900429].A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was initiated in December 2019 in 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. MAESTRO-NAFLD-1 also includes a 100 mg resmetirom open label arm in up to 100 patients. Unlike MAESTRO-NASH, MAESTRO-NAFLD-1 is a non-biopsy study and represents a “real-life” NASH study. NASH or presumed NASH is documented using historical liver biopsy or non-invasive techniques including fibroscan and MRI-PDFF. Using non-invasive measures, MAESTRO-NAFLD-1 is designed to provide incremental safety information to support the NASH indication as well as provide additional data regarding clinically relevant key secondary efficacy endpoints to better characterize the potential clinical benefits of resmetirom on cardiovascular and liver related endpoints. These key secondary endpoints include LDL-cholesterol, apolipoprotein B and triglyceride (TG) lowering; reduction of liver fat as determined by magnetic resonance imaging, proton density fat fraction (MRI-PDFF); and reduction of PRO-C3, a NASH fibrosis biomarker. [ClinicalTrials.gov/NCT04197479]   Additional secondary and exploratory endpoints will be assessed including reduction in liver enzymes, fibroscan scores and other fibrosis and inflammatory biomarkers. These and other data, including safety parameters, form the basis for potential subpart H submission to FDA for accelerated approval for the treatment of NASH. The original 900 patients in the MAESTRO-NASH study will continue on therapy after the initial 52-week treatment period; up to another 1,100 patients are to be added using the same randomization plan and the study is expected to continue for up to 54 months to accrue and measure clinical events, most relevantly progression to cirrhosis. About Resmetirom’s Potential to Confer Cardiovascular Risk Reduction in NASH patients Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a), as demonstrated in Phase 2, a key differentiating factor compared with other NASH therapeutics. The magnitude of reduction of these lipids support a potential indication for treatment of hyperlipidemia in NASH patients and predicts a potential for benefit on cardiovascular (CV) events in NASH patients who die most frequently of CV, not liver disease.Because of their diabetes, dyslipidemia, hypertension, obesity in concert with an inflamed, fatty liver, NASH patients, particularly those with advanced fibrosis, are at a substantially increased CV risk compared to the general population. Resmetirom’s ability to decrease liver fat, which is an independent risk factor for CV events, and resmetirom’s effect to reduce atherogenic lipids are being further evaluated in several key secondary endpoints in both MAESTRO Phase 3 clinical studies.About Madrigal Pharmaceuticals Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-in- class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAFLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit www.madrigalpharma.com.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, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control. Forward-looking statements include but are not limited to statements or references concerning: our clinical trials; research and development activities; the timing and results associated with the future development of our lead product candidate, MGL-3196 (resmetirom); our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections; optimal dosing levels for resmetirom; projections regarding potential future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment or biomarker effects with resmetirom; the predictive power of liver fat reduction on NASH resolution with fibrosis reduction or improvement; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; potential NASH or NAFLD patient risk profile benefits with resmetirom; and our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. Forward-looking statements: reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,”  “estimates,” “expects,” “forecasts,” “future,” “goal,” “hopeful,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “would” or similar expressions and the negatives of those terms.  Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements.Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: our clinical development of resmetirom; enrollment uncertainties, generally and in relation to COVID-19 shelter-in-place and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time; outcomes or trends from competitive studies; the risks of achieving potential benefits in  studies that includes substantially more patients than our prior studies; the timing and outcomes of clinical studies of resmetirom; and the uncertainties inherent in clinical testing. 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 filings with the U.S. Securities and Exchange Commission 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. We specifically discuss these risks and uncertainties in greater detail in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the period ended June 30, 2020, as well as in our other filings with the SEC. Investor Contact: Marc Schneebaum, Madrigal Pharmaceuticals, Inc. IR@madrigalpharma.comMedia Contact: Mike Beyer, Sam Brown Inc. mikebeyer@sambrown.com  312 961 2502
Wed, 02 Sep 2020
15:20:00 +0000
Intercept Pharmaceuticals Will Lay Off a Quarter of Its Staff as NASH Dream Fades
The company was once the front-runner in the race to develop a treatment for NASH, a newly defined liver disease
Wed, 26 Aug 2020
10:50:00 +0000
Madrigal Pharmaceuticals to Present Secondary Analyses of Data from Phase 2 NASH Study of Resmetirom and Symposium at the Digital International Liver Congress™ 2020
CONSHOHOCKEN, Pa., Aug. 26, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) announced today that on Friday, August 28, 2020 at the Digital International Liver Congress™ 2020, European Association for the Study of the Liver (EASL), secondary analyses of data from its Phase 2 NASH study with MGL-3196 (resmetirom) will be presented. Resmetirom is currently in Phase 3 development for the treatment of NASH patients with stage 2-3 fibrosis (ClinicalTrials.gov NCT03900429 and ClinicalTrials.gov/NCT04197479). Rohit Loomba, MD, MHSc, Professor of Medicine (with tenure), Division of Gastroenterology,  Department of Medicine, and Director, NAFLD Research Center and Director, Liver Epidemiology Training Program, University of California at San Diego, will present “Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to predict treatment response on NASH liver biopsy: a secondary analysis of the resmetirom randomised placebo-controlled phase 2 clinical trial” (AS077), during the Abstract session: NAFLD - Pharmacological Therapy, on Friday, August 28, 2020, at 12:00 PM CET (6:00 AM EDT).  Registered attendees will be able to watch the live presentation on the Digital ILC 2020 website, Channel 3.Dr. Loomba commented, “MRI-PDFF reduction has been shown to be associated with improvement in NASH components as assessed on liver biopsy. These secondary analyses of Madrigal’s Phase 2 NASH clinical trial add significant additional insight into the potential of PDFF to predict NASH response. These findings support the pathogenicity of liver steatosis in NASH and fibrosis progression.“Madrigal is excited to host four presentations by NASH experts, Impacting NASH: Focus on Liver and Cardiovascular Benefits, that registered attendees will be able to access via the Madrigal virtual booth on the Digital ILC 2020 website, on Friday, August 28, 2020, beginning at 1:00 PM CET.  The presentations will also be available via the Newsroom-Webcasts page on Madrigal’s website beginning at the same time: * “Epidemiology of NASH: CV- and Liver-related Outcomes” Zobair Younossi, MD, MPH, FACP, FACG, AGAF Chairman, Department of Medicine, Inova Fairfax Medical Campus. He is also Professor of Medicine, Virginia Commonwealth University, Inova Campus and Affiliate Professor of Biomedical Sciences at George Mason University. * Dr. Younossi focuses on global prevalence and trends in NAFLD/NASH, including the comprehensive burden of clinical, economic, and quality of life factors associated with the disease. * “Resmetirom for the Treatment of NASH” Stephen A. Harrison, MD Visiting Professor of Hepatology, Radcliffe Department of Medicine, University of Oxford, Oxford, England and Medical Director Pinnacle Clinical Research San Antonio, TX * Dr. Harrison discusses the non-invasive and clinical identification of patients at high risk for NASH with fibrosis, highlighting findings from the resmetirom clinical trial program. * “Real-life Treatment of NASH: Non-invasive Imaging in NASH Diagnosis and Treatment. Magnetic resonance imaging-proton density fat fraction (MRI-PDFF) to Predict Benefit in Patients with NASH: Focus on Resmetirom” Rohit Loomba, MD, MHSc Professor of Medicine (with tenure), Division of Gastroenterology,  Department of Medicine, and Director, NAFLD Research Center and Director, Liver Epidemiology Training Program, University of California at San Diego * Dr. Loomba provides an overview of MRI-PDFF as a non-invasive diagnostic for NASH and discusses findings from a secondary analysis of the resmetirom Phase 2 study that examine MRI-PDFF response as a predictor of histologic response in patients with NASH. * “The Intersection of CVD and NASH, the Next CVD Prevention Frontier” Seth Baum, MD, FACC, FACPM, FAHA, FNLA,FASPC Founder and CEO, Excel Medical Clinical Trials, and Clinical Affiliate Professor of Medicine at Florida Atlantic University (FAU) Medical School in Boca Raton, FL * Dr. Baum highlights topics of dyslipidemia, carotid-artery intimal medial thickness (CIMT), coronary artery calcification (CAC), and cardiovascular mortality in NAFLD/NASH, in addition to the role of resmetirom as experts consider cardiovascular disease in the NASH treatment landscape.About Resmetirom (MGL-3196) Thyroid hormone, through activation of its β-receptor in hepatocytes, plays a central role in liver function impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Thyroid hormone receptor (THR)-β action in the liver is key to proper function of the liver, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. Patients with NASH have reduced levels of thyroid hormone activity in the liver with resultant impaired hepatic function, in part due to the inflamed state of the liver that causes degradation of thyroid hormone.To exploit the thyroid hormone receptor (THR)-β pathway for therapeutic purposes in cardio-metabolic and liver diseases, it is important to avoid activity at the THR-α receptor, the predominant systemic receptor for thyroid hormone that is responsible for activity outside the liver including in heart and bone.  The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Resmetirom has been shown to be highly selective based on 1) THR- β receptor functional selectivity based on both in vitro and in vivo assays 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver. In short and long term human and animal studies, resmetirom has been confirmed to be safe and devoid of activity at the THR-α receptor and without impact on bone or cardiac parameters. Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist.About the Phase 3 Registration Program for the Treatment of NASH (Non-alcoholic steatohepatitis) Analyses from the resmetirom Phase 2 NASH study demonstrate that the magnitude of liver fat reduction accurately predicts NASH resolution and liver fibrosis reduction and, specifically, that the resmetirom doses being used in Madrigal’s Phase 3 MAESTRO-NASH trial could achieve the level of fat reduction predictive of NASH resolution and fibrosis reduction [Madrigal COVID and ABSTRACT Press Release_20200414].The Phase 3 MAESTRO-NASH trial is expected to enroll 900 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. After 52 weeks of treatment a second biopsy is performed. The primary surrogate endpoint on biopsy will be NASH resolution, with at least a 2-point reduction in NAS (NASH Activity Score), and with no worsening of fibrosis. Two key secondary endpoints are liver fibrosis improvement of at least one stage, with no worsening of NASH, and lowering of LDL-cholesterol [ClinicalTrials.gov/NCT03900429].A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was initiated in December 2019 in 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. MAESTRO-NAFLD-1 also includes a 100 mg resmetirom open label arm in up to 100 patients. Unlike MAESTRO-NASH, MAESTRO-NAFLD-1 is a non-biopsy study and represents a “real-life” NASH study. NASH or presumed NASH is documented using historical liver biopsy or non-invasive techniques including fibroscan and MRI-PDFF. Using non-invasive measures, MAESTRO-NAFLD-1 is designed to provide incremental safety information to support the NASH indication as well as provide additional data regarding clinically relevant key secondary efficacy endpoints to better characterize the potential clinical benefits of resmetirom on cardiovascular and liver related endpoints. These key secondary endpoints include LDL-cholesterol, apolipoprotein B and triglyceride (TG) lowering; reduction of liver fat as determined by magnetic resonance imaging, proton density fat fraction (MRI-PDFF); and reduction of PRO-C3, a NASH fibrosis biomarker. [ClinicalTrials.gov/NCT04197479]   Additional secondary and exploratory endpoints will be assessed including reduction in liver enzymes, fibroscan scores and other fibrosis and inflammatory biomarkers.These and other data, including safety parameters, form the basis for potential subpart H submission to FDA for accelerated approval for the treatment of NASH. The original 900 patients in the MAESTRO-NASH study will continue on therapy after the initial 52-week treatment period; up to another 1,100 patients are to be added using the same randomization plan and the study is expected to continue for up to 54 months to accrue and measure clinical events, most relevantly progression to cirrhosis. About Resmetirom’s Potential to Confer Cardiovascular Risk Reduction in NASH patients Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a), as demonstrated in Phase 2, a key differentiating factor compared with other NASH therapeutics. The magnitude of reduction of these lipids support a potential indication for treatment of hyperlipidemia in NASH patients and predicts a potential for benefit on cardiovascular (CV) events in NASH patients who die most frequently of CV, not liver disease.Because of their diabetes, dyslipidemia, hypertension, obesity in concert with an inflamed, fatty liver, NASH patients, particularly those with advanced fibrosis, are at a substantially increased CV risk compared to the general population. Resmetirom’s ability to decrease liver fat, which is an independent risk factor for CV events, and resmetirom’s effect to reduce atherogenic lipids are being further evaluated in several key secondary endpoints in both MAESTRO Phase 3 clinical studies.About Madrigal Pharmaceuticals Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-in- class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAGLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit www.madrigalpharma.com.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, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control. Forward-looking statements include but are not limited to statements or references concerning: our clinical trials; research and development activities; the timing and results associated with the future development of our lead product candidate, MGL-3196 (resmetirom); our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections; optimal dosing levels for resmetirom; projections regarding potential future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment or biomarker effects with resmetirom; the predictive power of liver fat reduction on NASH resolution with fibrosis reduction or improvement; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; potential NASH or NAFLD patient risk profile benefits with resmetirom; and our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. Forward-looking statements: reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,”  “estimates,” “expects,” “forecasts,” “future,” “goal,” “hopeful,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “would” or similar expressions and the negatives of those terms.  Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements.Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: our clinical development of resmetirom; enrollment uncertainties, generally and in relation to COVID-19 shelter-in-place and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time; outcomes or trends from competitive studies; the risks of achieving potential benefits in  studies that includes substantially more patients than our prior studies; the timing and outcomes of clinical studies of resmetirom; and the uncertainties inherent in clinical testing. 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 filings with the U.S. Securities and Exchange Commission 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. We specifically discuss these risks and uncertainties in greater detail in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the period ended June 30, 2020, as well as in our other filings with the SEC. Investor Contact: Marc Schneebaum, Madrigal Pharmaceuticals, Inc. IR@madrigalpharma.comMedia Contact: Mike Beyer, Sam Brown Inc. mikebeyer@sambrown.com  312 961 2502
Thu, 06 Aug 2020
10:50:00 +0000
Madrigal Pharmaceuticals Reports 2020 Second Quarter Financial Results and Highlights
CONSHOHOCKEN, Pa., Aug. 06, 2020 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its second quarter 2020 financial results and highlights: “The Madrigal team and our CRO’s are focused on completing enrollment of both of our Phase 3 MAESTRO clinical trials as rapidly as possible,” said Becky Taub, M.D., CMO and President, Research & Development of Madrigal.  “MAESTRO-NAFLD-1, a 52-week study in which NASH is diagnosed non-invasively, has enrolled well throughout 2020, and we anticipate completion of enrollment as scheduled by the end of 2020.  We expect to report data from an open label 100 mg arm of MAESTRO-NAFLD-1 by the end of this year, including selected data from noninvasive tests: liver fat (MRI-PDFF) at week 16, fibrosis biomarkers, liver enzymes, and atherogenic lipids and lipoproteins, key endpoints from the trial.”“The global coronavirus pandemic has presented significant challenges to the entire pharmaceutical industry in the conduct of clinical studies in 2020,” stated Paul Friedman, M.D., Chief Executive Officer of Madrigal.  “Consistent with guidance from regulatory agencies,  we put in place more flexible processes at clinical sites early on to allow patients to continue participating in our Phase 3 NASH studies.   Screening for MAESTRO-NASH was negatively impacted for some months by temporary closures of liver biopsy facilities that occurred globally. Screening and new enrollment are again underway. We have been and are continuing to apply multiple mitigation strategies to increase patient recruitment rates, including opening new trial sites and enrolling patients with existing biopsies from NASH trials which were discontinued and/or in which the drug was inactive in NASH.  We are hopeful that positive developments will allow us to make up the deficit that has occurred. However, the pandemic remains unpredictable, and completion of targeted enrollment for the serial liver biopsy portion of MAESTRO-NASH may be delayed past the end of 2020 by a few months.” Dr. Friedman continued, “On a different topic, we are also pleased to report that, effective today, NASDAQ has upgraded the listing of Madrigal’s common stock from the NASDAQ Capital Market (Tier 3) to the NASDAQ Global Select Market (Tier 1).  The Global Select Market  is for public companies that meet the highest listing standards in the world.”Financial Results for the Three and Six Months Ended June 30, 2020As of June 30, 2020, Madrigal had cash, cash equivalents and marketable securities of $384.4 million, compared to $439.0 million at December 31, 2019. The decrease in cash and marketable securities resulted primarily from cash used in operations of $54.8 million.Operating expenses were $50.3 million and $88.3 million for the three and six month periods ended June 30, 2020, compared to $22.7 million and $40.8 million in the comparable prior year periods.Research and development expenses for the three and six month periods ended June 30, 2020 were $44.7 million and $78.1 million, compared to $15.6 million and $28.0 million in the comparable prior year periods. The increases are primarily attributable to additional activities related to the Phase 3 clinical trials initiated in 2019, and an increase in head count.General and administrative expenses for the three and six month periods ended June 30, 2020 were $5.6 million and $10.2 million, compared to $7.1 million and $12.9 million in the comparable prior year periods.  The decreases in general and administrative expenses for the latest three and six month periods were due primarily to a decrease in non-cash stock compensation from stock option awards, which was partially offset by increases in other general and administrative expenses. Interest income for the three and six month periods ended June 30, 2020 was $1.2 million and $3.1 million, compared to $3.0 million and $6.0 million in the comparable prior year periods. The decreases in interest income for the latest three and six month periods were due primarily to lower average principal balances in our investment accounts in 2020, and decreased interest rates.About Resmetirom (MGL-3196) Thyroid hormone, through activation of its β-receptor in hepatocytes, plays a central role in liver function impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Thyroid hormone receptor (THR)-β action in the liver is key to proper function of the liver, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. Patients with NASH have reduced levels of thyroid hormone activity in the liver with resultant impaired hepatic function, in part due to the inflamed state of the liver that causes degradation of thyroid hormone.To exploit the thyroid hormone receptor (THR)-β pathway for therapeutic purposes in cardio-metabolic and liver diseases, it is important to avoid activity at the THR-α receptor, the predominant systemic receptor for thyroid hormone that is responsible for activity outside the liver including in heart and bone.  The lack of selectivity of older thyromimetic compounds, chemically-related toxicities and undesirable distribution in the body led to safety concerns. Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Resmetirom has been shown to be highly selective based on 1) THR- β receptor functional selectivity based on both in vitro and in vivo assays 2) specific uptake into the liver, its site of action, virtually avoiding any uptake into tissues outside the liver. In short and long term human and animal studies, resmetirom has been confirmed to be safe and devoid of activity at the THR-α receptor and without impact on bone or cardiac parameters. Resmetirom does not impact the thyroid axis hormones, including the central thyroid axis. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist.About the Phase 3 Registration Program for the Treatment of NASH (Non-alcoholic steatohepatitis) Analyses from the resmetirom Phase 2 NASH study demonstrate that the magnitude of liver fat reduction accurately predicts NASH resolution and liver fibrosis reduction and, specifically, that the resmetirom doses being used in Madrigal’s Phase 3 MAESTRO-NASH trial could achieve the level of fat reduction predictive of NASH resolution and fibrosis reduction [Madrigal COVID and ABSTRACT Press Release_20200414].The Phase 3 MAESTRO-NASH trial is expected to enroll 900 patients with biopsy-proven NASH (fibrosis stage 2 or 3), randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. After 52 weeks of treatment a second biopsy is performed. The primary surrogate endpoint on biopsy will be NASH resolution, with at least a 2-point reduction in NAS (NASH Activity Score), and with no worsening of fibrosis. Two key secondary endpoints are liver fibrosis improvement of at least one stage, with no worsening of NASH, and lowering of LDL-cholesterol [ClinicalTrials.gov/NCT03900429].A second 52-week Phase 3 multi-center, double-blind, randomized, placebo-controlled study of resmetirom, MAESTRO-NAFLD-1, was initiated in December 2019 in 700 patients with non-alcoholic fatty liver disease (NAFLD), presumed NASH, randomized 1:1:1 to receive resmetirom 80 mg once a day, 100 mg once a day, or placebo. MAESTRO-NAFLD-1 also includes a 100 mg resmetirom open label arm in up to 100 patients. Unlike MAESTRO-NASH, MAESTRO-NAFLD-1 is a non-biopsy study and represents a “real-life” NASH study. NASH or presumed NASH is documented using historical liver biopsy or non-invasive techniques including fibroscan and MRI-PDFF. Using non-invasive measures, MAESTRO-NAFLD-1 is designed to provide incremental safety information to support the NASH indication as well as provide additional data regarding clinically relevant key secondary efficacy endpoints to better characterize the potential clinical benefits of resmetirom on cardiovascular and liver related endpoints. These key secondary endpoints include LDL-cholesterol, apolipoprotein B and triglyceride (TG) lowering; reduction of liver fat as determined by magnetic resonance imaging, proton density fat fraction (MRI-PDFF); and reduction of PRO-C3, a NASH fibrosis biomarker. [ClinicalTrials.gov/NCT04197479]   Additional secondary and exploratory endpoints will be assessed including reduction in liver enzymes, fibroscan scores and other fibrosis and inflammatory biomarkers. These and other data, including safety parameters, form the basis for potential subpart H submission to FDA for accelerated approval for the treatment of NASH. The original 900 patients in the MAESTRO-NASH study will continue on therapy after the initial 52-week treatment period; up to another 1,100 patients are to be added using the same randomization plan and the study is expected to continue for up to 54 months to accrue and measure clinical events, most relevantly progression to cirrhosis. About Resmetirom’s Potential to Confer Cardiovascular Risk Reduction in NASH patients Additionally, resmetirom lowers multiple atherogenic lipids, including LDL cholesterol, apolipoprotein B, triglycerides, and lipoprotein (a), as demonstrated in Phase 2, a key differentiating factor compared with other NASH therapeutics. The magnitude of reduction of these lipids support a potential indication for treatment of hyperlipidemia in NASH patients and predicts a potential for benefit on cardiovascular (CV) events in NASH patients who die most frequently of CV, not liver disease.Because of their diabetes, dyslipidemia, hypertension, obesity in concert with an inflamed, fatty liver, NASH patients, particularly those with advanced fibrosis, are at a substantially increased CV risk compared to the general population. Resmetirom’s ability to decrease liver fat, which is an independent risk factor for CV events, and resmetirom’s effect to reduce atherogenic lipids are being further evaluated in several key secondary endpoints in both MAESTRO Phase 3 clinical studies.About Madrigal Pharmaceuticals Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, resmetirom, is a first-in- class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)-β selective agonist that is in currently in two Phase 3 clinical studies, MAESTRO-NASH and MAESTRO-NAGLD-1, designed to demonstrate multiple benefits across a broad spectrum of NASH (non-alcoholic steatohepatitis) and NAFLD (non-alcoholic fatty liver disease) patients. For more information, visit www.madrigalpharma.com.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, that are based on our beliefs and assumptions and on information currently available to us, but are subject to factors beyond our control. Forward-looking statements include but are not limited to statements or references concerning: our clinical trials; research and development activities; the timing and results associated with the future development of our lead product candidate, MGL-3196 (resmetirom); our primary and secondary study endpoints for resmetirom and the potential for achieving such endpoints and projections; optimal dosing levels for resmetirom; projections regarding potential future NASH resolution, safety, fibrosis treatment, cardiovascular effects, lipid treatment or biomarker effects with resmetirom; the predictive power of liver fat reduction on NASH resolution with fibrosis reduction or improvement; the achievement of enrollment objectives concerning patient number, safety database and/or timing for our studies; potential NASH or NAFLD patient risk profile benefits with resmetirom; and our possible or assumed future results of operations and expenses, business strategies and plans, capital needs and financing plans, trends, market sizing, competitive position, industry environment and potential growth opportunities, among other things. Forward-looking statements: reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events; include all statements that are not historical facts; and can be identified by terms such as “anticipates,” “be,” “believes,” “continue,” “could,” “demonstrates,” ”design,”  “estimates,” “expects,” “forecasts,” “future,” “goal,” “hopeful,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” ”predictive,” “projects,” “seeks,” “should,” “will,” “would” or similar expressions and the negatives of those terms.  Although management presently believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements.Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to: our clinical development of resmetirom; enrollment uncertainties, generally and in relation to COVID-19 shelter-in-place and social distancing measures and individual precautionary measures that may be implemented or continued for an uncertain period of time; outcomes or trends from competitive studies; the risks of achieving potential benefits in  studies that includes substantially more patients than our prior studies; the timing and outcomes of clinical studies of resmetirom; and the uncertainties inherent in clinical testing. 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 filings with the U.S. Securities and Exchange Commission 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. We specifically discuss these risks and uncertainties in greater detail in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and our Quarterly Report on Form 10-Q for the period ended June 30, 2020, as well as in our other filings with the SEC. Investor Contact: Marc Schneebaum, Madrigal Pharmaceuticals, Inc. IR@madrigalpharma.comMedia Contact: Mike Beyer, Sam Brown Inc. mikebeyer@sambrown.com  312 961 2502 (Tables Follow) Madrigal Pharmaceuticals, Inc.  Condensed Consolidated Statements of Operations  (in thousands, except share and per share amounts)  (unaudited)                           Three Months Ended Six Months Ended   June 30, June 30,    2020  2019   2020  2019   Revenues:         Total revenues$- $-  $- $-   Operating expenses:       Research and development 44,688  15,594   78,088  27,967   General and administrative 5,639  7,110   10,244  12,856   Total operating expenses 50,327  22,704   88,332  40,823   Loss from operations (50,327) (22,704)  (88,332) (40,823)    Interest income (expense), net 1,204  3,005   3,074  6,044     Other income 100  -   100  -   Net loss$(49,023)$(19,699) $(85,158)$(34,779)          Basic and diluted net loss per common share$(3.18)$(1.28) $(5.52)$(2.26)  Basic and diluted weighted average number of common shares outstanding 15,433,348  15,368,986   15,431,251  15,366,738                           Madrigal Pharmaceuticals, Inc.  Condensed Consolidated Balance Sheets   (in thousands)  (unaudited)                           June 30,December 31,       2020  2019              Assets       Cash, cash equivalents and marketable securities$384,380 $439,045      Other current assets 2,223  1,152      Other non-current assets 1,785  1,859        Total assets$388,388 $442,056              Liabilities and Equity       Current liabilities$45,275 $25,130      Long-term liabilities 197  361      Stockholders’ equity 342,916  416,565        Total liabilities and stockholders’ equity$388,388 $442,056
Sun, 28 Jun 2020
02:19:10 +0000
Should You Avoid Madrigal Pharmaceuticals, Inc. (MDGL)?
In this article you are going to find out whether hedge funds think Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) is a good investment right now. We like to check what the smart money thinks first before doing extensive research on a given stock. Although there have been several high profile failed hedge fund picks, the consensus picks […]
Wed, 17 Jun 2020
23:10:00 +0000
SHAREHOLDER ALERT: Levi & Korsinsky, LLP Reminds Shareholders of an Investigation Concerning Possible Breaches of Fiduciary Duty by Certain Officers and Directors of Madrigal Pharmaceuticals, Inc. - MDGL
NEW YORK, NY / ACCESSWIRE / June 17, 2020 / Levi & Korsinsky announces it has commenced an investigation of Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) concerning possible breaches of fiduciary duty. ...
Mon, 15 Jun 2020
21:19:33 +0000
Many 'Ifs' Surrounding Viking Therapeutics
The company needs to get liver disease drug approved and find help to commercialize it Continue reading...
Mon, 15 Jun 2020
19:56:00 +0000
Madrigal Pharmaceuticals Clears Key Benchmark, Hitting 80-Plus RS Rating
Madrigal Pharmaceuticals saw a positive improvement to its Relative Strength (RS) Rating on Monday, rising from 79 to 84. When looking for the best stocks to buy and watch, one factor to watch closely is relative price strength. This unique rating identifies market leadership by using a 1 (worst) to 99 (best) score that indicates how a stock's price action over the trailing 52 weeks matches up against the rest of the market.
Sat, 06 Jun 2020
16:29:00 +0000
3 Top Biotech Stocks to Buy in June
Investors seeking to beat the market should take a long and hard look at biotech stocks. Here are three top biotech stocks that I think are great picks to buy in June. There's too much to like about Vertex Pharmaceuticals (NASDAQ: VRTX) for it not to top the list.
Thu, 28 May 2020
12:07:36 +0000
We Think Madrigal Pharmaceuticals (NASDAQ:MDGL) Can Afford To Drive Business Growth
Just because a business does not make any money, does not mean that the stock will go down. For example, although...
Thu, 14 May 2020
21:31:55 +0000
After Drug Failure, Genfit's Cupboard Is Nearly Bare
Company’s high hopes for NASH drug stymied, providing opening for Intercept Pharma treatment Continue reading...
Sun, 10 May 2020
19:18:58 +0000
Was The Smart Money Right About Madrigal Pharmaceuticals (MDGL)?
Hedge funds don't get the respect they used to get. Nowadays investors prefer passive funds over actively managed funds. One thing they don't realize is that 100% of the passive funds didn't see the coronavirus recession coming, but a lot of hedge funds did. Even we published an article near the end of February and […]
Thu, 07 May 2020
10:50:10 +0000
Madrigal Pharmaceuticals Reports 2020 First Quarter Financial Results and Highlights
CONSHOHOCKEN, Pa., May 07, 2020 -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its first quarter 2020 financial results and highlights: “Madrigal continued to.
Tue, 05 May 2020
15:00:00 +0000
SHAREHOLDER ALERT: Levi & Korsinsky, LLP Announces an Investigation Concerning Possible Breaches of Fiduciary Duty by Certain Officers and Directors of Madrigal Pharmaceuticals, Inc. - MDGL
NEW YORK, NY / ACCESSWIRE / May 5, 2020 / Levi & Korsinsky announces it has commenced an investigation of Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) concerning possible breaches of fiduciary duty. To ...
Tue, 14 Apr 2020
10:50:10 +0000
Madrigal MAESTRO Phase 3 NASH Trials Continue without Protocol Modifications; New Data Demonstrate that Reductions in Liver Fat Achieved by Resmetirom Predict NASH Resolution and Fibrosis Reduction
-- MAESTRO Phase 3 clinical studies proceed, with more flexible allowances in visits and study drug dispensing for enrolled and screened patients at impacted sites, intended to.
Mon, 30 Mar 2020
22:06:25 +0000
FDA Decisions on 5 Drugs Expected in 2nd Quarter
Intercept Pharmaceuticals hoping for approval on medication to compete in large and fast-growing market for NASH treatments Continue reading...
Fri, 28 Feb 2020
15:49:44 +0000
What Kind Of Share Price Volatility Should You Expect For Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL)?
If you own shares in Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) then it's worth thinking about how it contributes to...
Wed, 26 Feb 2020
11:50:10 +0000
Madrigal Pharmaceuticals Reports 2019 Fourth Quarter and Full Year Financial Results and Highlights
CONSHOHOCKEN, Pa., Feb. 26, 2020 -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) today announced its fourth quarter and full year 2019 financial results and highlights:.
Wed, 05 Feb 2020
21:11:53 +0000
13 Key NASH Drug Candidates To Watch For In A Potential $30-Billion Market
Non-alcoholic steatohepatitis, or NASH, is a metabolic disorder caused by a buildup of fat in the liver, leading to liver inflammation and damage. It belongs to a group of conditions called non-alcoholic ...
Tue, 21 Jan 2020
18:27:38 +0000
Is It Time to Buy These 3 Beaten-Down Stocks? Analysts Say Yes
The term 'buy when there's blood in the streets' was coined in the 18th century by Baron Rothchild. The contrarian act, as most investors know, is a preemptive call to load up on shares of downtrodden and badly performing companies that have recently taken a severe beating in the market but present the perfect timing to invest. While some investors automatically avoid underperforming names, the ones willing to take the risk can often receive handsome reward once the company at question executes a turnaround.Wall Street pros know the system well and are often on the lookout for such opportunities. With this in mind, We'll open up the TipRanks database and take a look at three beaten down stock which those in the know think are ripe for a trend reversal. We used TipRanks’ Stock Screener to get the lowdown, and we also noticed that currently all three boast Strong Buy consensus ratings from the Street. Let’s check them out.World Wrestling Entertainment (WWE)Talk about bloody and beaten down stocks leads us nicely into the first name on our list; World Wrestling Entertainment. In contrast to the S&P 500’s record breaking performance last year, WWE lost almost 13% of its share price in 2019. The drop was reflected in WWE’s waning popularity – lower live attendances and TV ratings on top of less streaming subscribers are all worrying trends for the company.That’s the bad news, then. The good news is that WWE has taken care of TV revenue for the next 5 years. The company’s new US deal for its Raw and SmackDown programs should see it pocket in the region of $500 million annually over the period, which is approximately double what it made in the past year. Furthermore, its NXT brand brings in from Comcast an additional $30 million a year. With more international deals in place, the question is whether the company can turn around the declining figures to ensure its longevity once the current deals expire.Needham’s Laura Martin thinks WWE has what it takes. The 5-star analyst recently interviewed WWE’s management and came away confident in its prospects. Martin said, “WWE believes it can continue to grow US subs, even in the context of more fragmentation of audiences, suggesting that super-fandom niche OTT service are largely immune from the Streaming Wars between deep-pocketed general entertainment SVOD services. If true, this has positive implications for WWE's pricing power. Also, WWE uses social media and its linear TV air-time to lower its customer acquisition costs for its new OTT subscribers."Martin, therefore, reiterated her Buy rating on WWE. The 5-star analyst’s price target comes in at $88 and represents potential upside of 40%. (To watch Martin’s track record, click here)The Street agrees. A unanimous 10 Buy ratings dished out over the last 3 months presents WWE with a Strong Buy consensus rating. The average price target of $81.56 implies possible upside of 30%. (See WWE stock analysis on TipRanks)Ollie's Bargain Outlet (OLLI)Ollie's Bargain Outlet stock had quite a ride last year, increasing by over 50% before crashing back down whilst shedding 40% of its value. 2020 hasn’t kicked off all that well either; Ollie’s is down by nearly 18% year-to-date.The sell-off comes despite a better than expected F3Q19 report. Net sales of $327 million represented an improvement of 15.3% year-over-year and resulted in adjusted (non-GAAP) net income of $26.8 million, an increase of 28% over the same period in the prior year.Ollie’s has also been expanding opportunistically; last year the company bought 12 Toys R Us locations and leased six others around the country following the former toy giant’s bankruptcy. It also purchased almost $200 million dollars of toys from Toys R Us suppliers’ excess inventory.So, with Mr. Market being unkind to Ollie’s, should investors stay away? Not according to RBC analyst Scot Ciccarelli.The 5-star analyst believes the recent sell-off spells opportunity, noting, “We think Ollie’s has one of the best long-term store growth profiles in the Hardlines/Broadlines Retail sector. Further, the company’s stores generate strong cash-on-cash returns of ~60%+, with 4-wall EBITDA of $585,000–600,000 ($630,000 in most recent vintages) on an initial $1 million investment. In addition, its constantly changing/treasure hunt-oriented shopping experience, coupled with its steep clearance-level prices, should help insulate the company against e-commerce cannibalization.”Accordingly, Ciccarelli reiterated an Outperform rating on Ollie’s, while raising his price target from $69 to $76. The new price target represents possible gains in the shape of 42.5%. (To watch Ciccarelli’s track record, click here)Based on the consensus breakdown, the majority on the Street also back the discount retailer’s prospects in 2020. 4 Buys and a single hold assigned over the last 3 months amount to a Strong Buy consensus rating. At $72, the average price target presents possible upside of ~36%. (See OLLI stock analysis on TipRanks)Madrigal Pharmaceuticals Inc (MDGL)Completing our trio of beaten down stocks is Madrigal Pharmaceuticals, which saw its shares falling nearly 20% in 2019.In mid-December, the drugmaker's shares responded negatively to the announcement that a few investment funds affiliated with Bay City Capital are heading for the exits. The funds offered 1,200,000 Madrigal shares at $107.85 apiece -- a 9% discount to the previous closing price. In other words, the funds probably had to price the offering at a discount simply to entice investors.But things aren’t as bad as they may seem, argues Evercore analyst Joshua Schimmer.Madrigal is one of several companies hoping to bring a therapy for NASH disease (Non-Alcoholic SteatoHepatitis), a fatty liver disease that due to the obesity epidemic has been attracting lots of investment capital in search of a possible treatment. NASH medications are expected to increase into a massive market over the next decade, and as there are currently no NASH-specific drugs available, whoever brings a viable solution to the market will likely be well rewarded.Madrigal's lead drug candidate is resmetirom (MGL-3196), an orally administered, thyroid hormone receptor (THR) β-selective agonist. The drug is currently in a Phase 3 trial, after showing positive data in the 2 prior trials.Schimmer thinks “2020 is an execution year” for Madrigal. The 5-star analyst said, “We continue to believe that resmetirom may have a differentiated profile, as a clean, oral therapy… the company’s P2 dataset continues to stack up well to the competition which has seen multiple recent disappointments in the field. We continue to believe that resmetirom (MGL-3196) has a strong chance of success in P3, with results expected in ~2021.”To this end, Schimmer reiterated an Outperform rating on Madrigal along with a price target of $250. This implies upside potential of a massive 192%. (To watch Schimmer’s track record, click here)On the Street, Madrigal’s Strong Buy consensus rating breaks down into 6 Buys and 1 Hold. The average price target of $169.67 implies upside potential in the shape of 100% over the next 12 months. (See Madrigal stock analysis on TipRanks)



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