Madrigal Pharmaceuticals

Madrigal NASH drug meets goals in much-awaited trial, shares surge

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.

The data gives the company a timely boost after it raised “going concern” doubts in November citing lack of adequate cash.

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 drug resmetirom also showed 1-stage improvement in fibrosis or scarring with no worsening of fatty liver disease in 24% of patients, compared to 26% for a higher 100 milligram dose, and 14% for placebo.

“With these unequivocally positive Phase 3 data in hand, our path forward is clear,” said Chief Executive Officer Paul Friedman.

The company plans to file a marketing application seeking accelerated approval for the drug in the first half of 2023.

Goldman Sachs analyst Andrea Tan has pegged peak global sales for the drug at $4.1 billion in 2033.

Madrigal’s shares more than tripled in premarket trading to $201.

Reporting by Leroy Leo and Raghav Mahobe and Sriparna Roy in Bengaluru; Additional reporting by Manas Mishra; Editing by Sriraj Kalluvila, Krishna Chandra Eluri and Shailesh Kuber

Our Standards: The Thomson Reuters Trust Principles.

Source: Reuters