Madrigal (MDGL), Soars when Resmetirom Reaches Goal in NASH Studies
Shares Madrigal Pharmaceuticals, Inc. MDGL rose 268.1% to close at 268.9% on December 19, after MDGL announced positive top-line results from phase III MAESTRO–NASH, which evaluated its lead candidate resmetirom in treating nonalcoholic steatohepatitis 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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Patients receiving both the 80 mg and 100 mg daily doses of resmetirom were able to achieve both primary and secondary endpoints. This was in comparison to patients receiving placebo.
The FDA proposed that the study achieve liver histological improvement endpoints. This is expected to predict clinical benefit and support the FDA’s rapid approval of resmetirom in the treatment of NASH with fibrosis.
Resmetirom treatment also showed potentially clinically meaningful LDL reduction, a key secondary outcome of the above-mentioned research.
Resmetirom treatment was well tolerated and safe.
Madrigal intends to file a NDA (new drug application) seeking an expedited approval of resmetirom treatment for non-cirrhotic NASH/liver fibrosis. This will be done in the first quarter 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, a progressive form non-alcoholicfatty liver disease, is characterised by excessive fat buildup and inflammation in the liver. Inflammation and fibrosis can lead to liver failure, cancer, and even death.
The NASH market has potential, even though there aren’t any approved treatments. It is however challenging because many companies are trying to create a treatment.
Intercept Pharmaceuticals ICPT is evaluating obeticholic acids (OCA) in NASH.
In June 2022 ICPT reported positive top-line numbers from a new interim study of the pivotal phase III REGENERATE clinical trial. This was evaluating OCA’s efficacy in patients with liver fibrosis (NASH) and other conditions.
Based on the study’s results, Intercept will resubmit its NDA for OCA to treat liver fibrosis due to NASH.
Intercept received a complete FDA reply letter in June 2020.
Another company Viking Therapeutics VKTX is currently developing VK2809 to treat biopsy-confirmed NASH/fibrosis.
VK2809 is being evaluated in a phase IIb trial in NASH patients. VKTX anticipates that the study will be completed in the near future.
Akero Therapeutics AKRO is currently evaluating efruxifermin (EFX), its lead candidate for NASH treatment.
AKRO reported positive results from cohort C in its phase IIa Balanced study, evaluating EFX to treat NASH.
Akero is currently evaluating EFX for two phase IIb studies in patients diagnosed with biopsy-confirmed NASH. These are the HARMONY and SYMMETRY studies in patients with precirrhotic NASH.
Zacks Rank
Madrigal currently has a Zacks rank #4 (Sell).
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