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Madrigal (MDGL) Soars as Resmetirom Meets Goal in NASH Study

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Shares of Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) were up a whopping 268.1% on Dec 19 after the company announced positive top-line data from the pivotal phase III MAESTRO-NASH study evaluating its lead candidate resmetirom for treating nonalcoholic steatohepatitis (NASH) and liver fibrosis.

The stock has surged 177.1% so far this year against the industry’s decline of 31.3%.

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Data from the 52-week serial liver biopsy phase III study showed that patients treated with both daily oral doses of resmetirom (80 mg and 100 mg) achieved both primary endpoints and potentially clinically meaningful effects as compared to placebo.

The study achieved both liver histological improvement endpoints as proposed by the FDA, which is likely to predict clinical benefit to support accelerated approval of resmetirom for the treatment of NASH with liver fibrosis.

Treatment with resmetirom also demonstrated potentially clinically meaningful LDL-reduction, a key secondary endpoint of the above-mentioned study.

Treatment with resmetirom was safe and well-tolerated.

Madrigal plans to file a new drug application or NDA seeking accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis in the first half of 2023.

Apart from MAESTRO-NASH, Madrigal is presently conducting MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE, and MAESTRO-NASH-OUTCOMES to demonstrate the safety and efficacy of resmetirom for the treatment of NASH.

NASH is a progressive form of non-alcoholic fatty liver disease, characterized by excessive fat buildup in the liver, accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death.

While the NASH market holds potential with no approved therapies yet, it is challenging as several companies are trying to develop a successful treatment for the same.

Intercept Pharmaceuticals (ICPT - Free Report) is evaluating obeticholic acid (OCA) for NASH.

In June 2022, ICPT announced positive top-line data from a new interim analysis of its pivotal phase III REGENERATE study, evaluating the efficacy of OCA in patients with liver fibrosis due to NASH.

Based on the study’s results, Intercept will resubmit its NDA for OCA to treat liver fibrosis due to NASH.

Intercept received a complete response letter from the FDA in June 2020.

Another company, Viking Therapeutics (VKTX - Free Report) , is developing VK2809 for biopsy-confirmed NASH and fibrosis.

VK2809 is currently being evaluated in a phase IIb study in patients with NASH. VKTX expects to complete enrollment in the study shortly.

Akero Therapeutics (AKRO - Free Report) is evaluating its lead candidate efruxifermin (EFX) for treating NASH.

In August 2022, AKRO announced positive results from cohort C of its phase IIa BALANCED study, evaluating EFX for treating NASH.

Presently, Akero is also evaluating EFX in two phase IIb studies in patients with biopsy-confirmed NASH, namely, the HARMONY study being conducted in patients with pre-cirrhotic NASH and the SYMMETRY study in cirrhotic patients.

Zacks Rank

Madrigal currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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