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Madrigal (MDGL) Stock Up as FDA Approves First Drug for NASH
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Madrigal Pharmaceuticals (MDGL - Free Report) announced that the FDA has granted accelerated approval to its drug, resmeritom, to treat patients with nonalcoholic steatohepatitis (NASH) with moderate- to-advanced liver fibrosis. The drug, which is the first and the only medication approved by the FDA for treating NASH, will be marketed by the name of Rezdiffra. NASH is also known as metabolic dysfunction associated steatohepatitis (MASH).
Shares of the company were up 23.8% in after-hours trading on Mar 14 following the FDA approval. The approval of Rezdiffra is a huge boost for Madrigal. With no treatment currently approved to treat NASH, the market opportunity is substantially large. Importantly, the drug’s label does not include a requirement for liver biopsy for diagnosis.
Madrigal shares have plunged 0.9% in the past year compared with the industry's 4.2% decline.
Image Source: Zacks Investment Research
Rezdiffra is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist, designed to target key underlying causes of NASH in the liver.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver, inducing chronic inflammation and resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
The approval of Rezdiffra was based on data from a phase III study called MAESTRO-NASH. In the study, treatment with Rezdiffra for 52 weeks led to a statistically significant improvement in scarring/fatty deposits and also fibrosis, the two main goals of the study. Rezdiffra is expected to be launched in April.
The full approval of Rezdiffra will remain contingent upon verification of clinical benefit in a confirmatory study. MAESTRO-NASH is ongoing as an outcomes study, which will serve as the confirmatory study. Another outcomes study is also ongoing, which is evaluating Rezdiffra versus placebo for progression to liver decompensation events in patients with well-compensated NASH cirrhosis.
Several other companies, like Viking Therapeutics (VKTX - Free Report) and Akero Therapeutics (AKRO - Free Report) , are developing a treatment for NASH/MASH.
Viking is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. In October 2023, Viking reported positive data from the VOYAGE study, a phase IIb study designed to evaluate VK2809 in patients with NASH and fibrosis. The study met its primary endpoint of a statistically significant reduction in liver fat content in NASH, along with significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides and atherogenic lipoproteins against placebo. The 52-week biopsy data from this study are expected to be announced in the first half of 2024.
Akero is evaluating its lead candidate, efruxifermin (EFX), for treating NASH. Toward the end of 2023, Akero initiated two phase III studies as part of the late-stage SYNCHRONY program to evaluate EFX for the treatment of patients with pre-cirrhotic MASH. In February 2024, it reported data from the second on-treatment biopsy in the 96-week phase IIb HARMONY study in patients with pre-cirrhotic MASH. Akero expects to initiate its third phase III SYNCHRONY study in patients with cirrhosis due to MASH later this year.
Meanwhile, Eli Lilly’s (LLY - Free Report) highly successful dual GIP and GLP-1 receptor agonist, tirzepatide, is also being evaluated in mid-stage studies for NASH. Lilly’s tirzepatide is approved as Mounjaro for treating type-II diabetes and as Zepbound to treat obesity. Novo Nordisk’s semaglutide, also a GLP-1 drug, is being evaluated in a phase III study for NASH. Semaglutide is approved as Ozempic and Rybelsus for type II diabetes and Wegovy for obesity.
Image: Bigstock
Madrigal (MDGL) Stock Up as FDA Approves First Drug for NASH
Madrigal Pharmaceuticals (MDGL - Free Report) announced that the FDA has granted accelerated approval to its drug, resmeritom, to treat patients with nonalcoholic steatohepatitis (NASH) with moderate- to-advanced liver fibrosis. The drug, which is the first and the only medication approved by the FDA for treating NASH, will be marketed by the name of Rezdiffra. NASH is also known as metabolic dysfunction associated steatohepatitis (MASH).
Shares of the company were up 23.8% in after-hours trading on Mar 14 following the FDA approval. The approval of Rezdiffra is a huge boost for Madrigal. With no treatment currently approved to treat NASH, the market opportunity is substantially large. Importantly, the drug’s label does not include a requirement for liver biopsy for diagnosis.
Madrigal shares have plunged 0.9% in the past year compared with the industry's 4.2% decline.
Image Source: Zacks Investment Research
Rezdiffra is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist, designed to target key underlying causes of NASH in the liver.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver, inducing chronic inflammation and resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
The approval of Rezdiffra was based on data from a phase III study called MAESTRO-NASH. In the study, treatment with Rezdiffra for 52 weeks led to a statistically significant improvement in scarring/fatty deposits and also fibrosis, the two main goals of the study. Rezdiffra is expected to be launched in April.
The full approval of Rezdiffra will remain contingent upon verification of clinical benefit in a confirmatory study. MAESTRO-NASH is ongoing as an outcomes study, which will serve as the confirmatory study. Another outcomes study is also ongoing, which is evaluating Rezdiffra versus placebo for progression to liver decompensation events in patients with well-compensated NASH cirrhosis.
Several other companies, like Viking Therapeutics (VKTX - Free Report) and Akero Therapeutics (AKRO - Free Report) , are developing a treatment for NASH/MASH.
Viking is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. In October 2023, Viking reported positive data from the VOYAGE study, a phase IIb study designed to evaluate VK2809 in patients with NASH and fibrosis. The study met its primary endpoint of a statistically significant reduction in liver fat content in NASH, along with significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides and atherogenic lipoproteins against placebo. The 52-week biopsy data from this study are expected to be announced in the first half of 2024.
Akero is evaluating its lead candidate, efruxifermin (EFX), for treating NASH. Toward the end of 2023, Akero initiated two phase III studies as part of the late-stage SYNCHRONY program to evaluate EFX for the treatment of patients with pre-cirrhotic MASH. In February 2024, it reported data from the second on-treatment biopsy in the 96-week phase IIb HARMONY study in patients with pre-cirrhotic MASH. Akero expects to initiate its third phase III SYNCHRONY study in patients with cirrhosis due to MASH later this year.
Meanwhile, Eli Lilly’s (LLY - Free Report) highly successful dual GIP and GLP-1 receptor agonist, tirzepatide, is also being evaluated in mid-stage studies for NASH. Lilly’s tirzepatide is approved as Mounjaro for treating type-II diabetes and as Zepbound to treat obesity. Novo Nordisk’s semaglutide, also a GLP-1 drug, is being evaluated in a phase III study for NASH. Semaglutide is approved as Ozempic and Rybelsus for type II diabetes and Wegovy for obesity.
Zacks Rank
Madrigal Pharmaceuticals currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Madrigal Pharmaceuticals, Inc. price-consensus-chart | Madrigal Pharmaceuticals, Inc. Quote