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Madrigal (MDGL) Gains on NDA for NASH Therapy Acceptance by FDA
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Madrigal Pharmaceuticals’ (MDGL - Free Report) new drug application (NDA) for resmeritom to treat patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis, got accepted by the FDA for review. Shares of the company were up 7.7% on Sep 13, following the development.
The regulatory body granted priority review and set a Prescription Drug User Fee Act date of 14 Mar, 2024.The company is seeking approval to treat patients with NASH and liver fibrosis through the FDA’s accelerated approval pathway.
Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist, designed to target key underlying causes of NASH in the liver.
The FDA grants Priority Review to applications for medicines that, if approved, would mark significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. A Priority Review designation signifies FDA’s intent to take action on an application within six months (compared to 10 months under standard review).
The clinical development of resmeritom was based on eighteen clinical studies, including twelve early-stage, two mid-stage and four late-stage studies.
Madrigal shares have plunged 34.4% year to date compared with the industry's 3.2% decline.
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 potential approval and successful commercialization of resmeritom will be a huge boost for Madrigal. With no treatment currently approved to address this disease, the market opportunity is substantially large.
Several other companies like Viking Therapeutics (VKTX - Free Report) and Akero Therapeutics (AKRO - Free Report) are trying to develop a treatment for the same condition.
Viking is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. In May, 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 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.
Akero is evaluating its lead candidate efruxifermin (EFX) for treating NASH. It is on track to report 36-week treatment data from the phase IIb SYMMETRY main study evaluating EFX in adult patients with cirrhotic NASH in October 2023. Akero is also on track to initiate two phase III studies as part of the late-stage SYNCHRONY program in second-half 2023 to evaluate EFX in NASH.
Madrigal Pharmaceuticals, Inc. Price and Consensus
In the past 90 days, the Zacks Consensus Estimate for Anika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.32 for 2023. The bottom-line estimate has narrowed from a loss of 79 cents to a loss of 64 cents for 2024 during the same time frame. Shares of the company have lost 42.4% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
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Madrigal (MDGL) Gains on NDA for NASH Therapy Acceptance by FDA
Madrigal Pharmaceuticals’ (MDGL - Free Report) new drug application (NDA) for resmeritom to treat patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis, got accepted by the FDA for review. Shares of the company were up 7.7% on Sep 13, following the development.
The regulatory body granted priority review and set a Prescription Drug User Fee Act date of 14 Mar, 2024.The company is seeking approval to treat patients with NASH and liver fibrosis through the FDA’s accelerated approval pathway.
Resmetirom is a once daily, oral, thyroid hormone receptor (THR)-β selective agonist, designed to target key underlying causes of NASH in the liver.
The FDA grants Priority Review to applications for medicines that, if approved, would mark significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. A Priority Review designation signifies FDA’s intent to take action on an application within six months (compared to 10 months under standard review).
The clinical development of resmeritom was based on eighteen clinical studies, including twelve early-stage, two mid-stage and four late-stage studies.
Shares of the company also soared earlier in April, as resmeritom was granted Breakthrough Therapy designation by the FDA for treating patients with NASH with liver fibrosis. The designation expedites the development and review of drugs for severe or life-threatening conditions.
Image Source: Zacks Investment Research
Madrigal shares have plunged 34.4% year to date compared with the industry's 3.2% decline.
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 potential approval and successful commercialization of resmeritom will be a huge boost for Madrigal. With no treatment currently approved to address this disease, the market opportunity is substantially large.
Several other companies like Viking Therapeutics (VKTX - Free Report) and Akero Therapeutics (AKRO - Free Report) are trying to develop a treatment for the same condition.
Viking is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. In May, 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 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.
Akero is evaluating its lead candidate efruxifermin (EFX) for treating NASH. It is on track to report 36-week treatment data from the phase IIb SYMMETRY main study evaluating EFX in adult patients with cirrhotic NASH in October 2023. Akero is also on track to initiate two phase III studies as part of the late-stage SYNCHRONY program in second-half 2023 to evaluate EFX in NASH.
Madrigal Pharmaceuticals, Inc. Price and Consensus
Madrigal Pharmaceuticals, Inc. price-consensus-chart | Madrigal Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to Consider
Madrigal currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the same industry is Anika Therapeutics (ANIK - Free Report) , carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Anika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.32 for 2023. The bottom-line estimate has narrowed from a loss of 79 cents to a loss of 64 cents for 2024 during the same time frame. Shares of the company have lost 42.4% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.