Dec 19 (Reuters) - Madrigal Pharmaceuticals' (MDGL.O) experimental drug for fatty liver disease met both of the main goals in a highly anticipated late-stage study, it said on Monday, sending the company's shares soaring over 200%.
The positive data sets the stage for the drug, resmetirom, to become the first approved treatment for NASH, or nonalcoholic steatohepatitis, a disease that affects about 5% of adults in the United States.
Data from the trial shows a lower 80 milligram dose helped 26% of patients reach NASH resolution, compared to 30% for a higher 100 milligram dose, and 10% for placebo.
NASH is a form of nonalcoholic fatty liver disease, characterized by the organ developing fibrosis or scarring, which can progress to cirrhosis and liver failure.
The company plans to file a marketing application seeking accelerated approval for the drug in the first half of 2023.