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Madrigal (MDGL) Gains on NASH Treatment's Breakthrough Therapy Tag
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Madrigal Pharmaceuticals' (MDGL - Free Report) shares were up almost 13% on Apr 18, as its pipeline candidate, resmetirom, obtained Breakthrough Therapy designation from the FDA for treating patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis. Additionally, the company announced enrollment completion for the outcomes part of the phase III MAESTRO-NASH biopsy study.
The designation expedites the development and review of drugs for severe or life-threatening conditions. The criteria require preliminary clinical evidence, indicating that the drug may substantially improve at least one clinically significant endpoint over available therapy or over placebo if there is no available therapy.
As the drug receives the "Breakthrough Therapy" title, it becomes eligible for more detailed advice on establishing an effective drug development program and an organizational commitment.
Madrigal Pharmaceuticals’ shares have plunged 269.1% in the past year compared with the industry's 14.9% decline.
Image Source: Zacks Investment Research
NASH is a progressive form of nonalcoholic fatty liver disease, characterized by excessive fat buildup in the liver. It is also accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death.
Resmetirom isa once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Madrigal Pharmaceuticals is currently conducting four phase III clinical trials to demonstrate the safety and efficacy of resmetirom in the treatment of NASH.
The MAESTRO-NASH trial is a multicenter, randomized, double-blind, placebo-controlled study of resmetirom in patients with liver biopsy-confirmed NASH.
The MAESTRO-NAFLD-1 trial is a 52-week multicenter, randomized, placebo-controlled Phase 3 study of resmetirom in more than 1,200 patients with NAFLD.
The MAESTRO-NAFLD-OLE trial is an open-label extension study of MAESTRO-NAFLD-1. The MAESTRO-NASH-OUTCOMES trial is a clinical outcome trial evaluating resmetirom in patients with well-compensated NASH cirrhosis. The data from the trials provide a second and potentially earlier opportunity to support full approval for both noncirrhotic and cirrhotic NASH. The outcome study is fully enrolled with approximately 1750 patients.
MDGL intends to file a new drug application for resmetirom by the second quarter of 2023. NASH is a challenging but promising market, and the successful development of a treatment for the same will significantly boost for the company’s performance.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.22 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company's shares have plunged 9.8% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 61.8% in the past year.
The company's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company's shares have plunged 39.4% in the past year.
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Madrigal (MDGL) Gains on NASH Treatment's Breakthrough Therapy Tag
Madrigal Pharmaceuticals' (MDGL - Free Report) shares were up almost 13% on Apr 18, as its pipeline candidate, resmetirom, obtained Breakthrough Therapy designation from the FDA for treating patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis. Additionally, the company announced enrollment completion for the outcomes part of the phase III MAESTRO-NASH biopsy study.
The designation expedites the development and review of drugs for severe or life-threatening conditions. The criteria require preliminary clinical evidence, indicating that the drug may substantially improve at least one clinically significant endpoint over available therapy or over placebo if there is no available therapy.
As the drug receives the "Breakthrough Therapy" title, it becomes eligible for more detailed advice on establishing an effective drug development program and an organizational commitment.
Madrigal Pharmaceuticals’ shares have plunged 269.1% in the past year compared with the industry's 14.9% decline.
Image Source: Zacks Investment Research
NASH is a progressive form of nonalcoholic fatty liver disease, characterized by excessive fat buildup in the liver. It is also accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death.
Resmetirom isa once daily, oral, thyroid hormone receptor (THR)-β selective agonist designed to target key underlying causes of NASH in the liver.
Madrigal Pharmaceuticals is currently conducting four phase III clinical trials to demonstrate the safety and efficacy of resmetirom in the treatment of NASH.
The MAESTRO-NASH trial is a multicenter, randomized, double-blind, placebo-controlled study of resmetirom in patients with liver biopsy-confirmed NASH.
The MAESTRO-NAFLD-1 trial is a 52-week multicenter, randomized, placebo-controlled Phase 3 study of resmetirom in more than 1,200 patients with NAFLD.
The MAESTRO-NAFLD-OLE trial is an open-label extension study of MAESTRO-NAFLD-1. The MAESTRO-NASH-OUTCOMES trial is a clinical outcome trial evaluating resmetirom in patients with well-compensated NASH cirrhosis. The data from the trials provide a second and potentially earlier opportunity to support full approval for both noncirrhotic and cirrhotic NASH. The outcome study is fully enrolled with approximately 1750 patients.
MDGL intends to file a new drug application for resmetirom by the second quarter of 2023. NASH is a challenging but promising market, and the successful development of a treatment for the same will significantly boost for the company’s performance.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Madrigal Pharmaceuticals, Inc. price-consensus-chart | Madrigal Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Madrigal Pharmaceuticals has a Zacks Rank #3 (Hold).
Some better-ranked stocks for investors interested in the same sector are CRISPR Therapeutics (CRSP - Free Report) , Kala Pharmaceuticals (KALA - Free Report) and Allogene Therapeutics (ALLO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for CRISPR Therapeutics have narrowed from $8.21 to $7.22 for 2023 in the past 60 days.
CRSP's earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, the average surprise being 3.19%. The company's shares have plunged 9.8% in the past year.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $18.34 to $16.54 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. KALA's shares have plunged 61.8% in the past year.
The company's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Loss per share estimates for Allogene Therapeutics have narrowed from $2.83 to $2.44 for 2023 and from $2.69 to $2.46 for 2024 in the past 60 days.
ALLO's earnings beat estimates in each of the trailing four quarters, the average surprise being 8.33%. The company's shares have plunged 39.4% in the past year.