MDGL - Madrigal Pharmaceuticals: Eli Lilly's NASH Data Threatens Resmetirom's Potential

2024-02-06 19:32:41 ET

Summary

• Madrigal Pharmaceuticals is leading the race to secure approval for its drug Resmetirom to treat NASH, now known as MASH, a form of fatty liver disease.
• Eli Lilly's drug tirzepatide, which has already secured approvals for Type 2 diabetes and obesity, poses a threat to Madrigal's Resmetirom in the NASH market.
• Lilly's Phase 2 data for tirzepatide in NASH / MASH established the drug as a major threat to resmetirom.
• Resmetirom's peak revenue opportunity, once thought to be $5-$10bn, is now estimated to be ~$1bn by some analysts.
• Even that figure may prove hard to reach - Resmetirom's PDUFA date - when the FDA rules on whether to approve it for commercial use - arrives next month.

Investment Overview

Madrigal Pharmaceuticals ( MDGL ), the Conshohocken, Pennsylvania based biotech, is the current leader of the "NASH Dash", that is, the race to secure a first approval for a drug developed to treat nonalcoholic steatohepatitis, or "NASH" an advanced form of non-alcoholic fatty liver disease ("NAFLD"), where buildups of fat in the liver begin to cause inflammation, fibrosis, followed by cirrhosis, which can cause life-threatening morbidities or necessitate a liver transplant....

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