LLY - Madrigal Wins The 'MASH Dash' And A Chance To Shape The Market Before GLP-1 Challenge

2024-03-15 13:32:49 ET

Summary

• Madrigal Pharmaceuticals has secured accelerated approval from the FDA for its drug Resmetirom, which treats nonalcoholic steatohepatitis (NASH), now known as metabolic dysfunction-associated steatohepatitis ("MASH").
• The drug has received accelerated approval, meaning it could be withdrawn from the market if its post-confirmatory study fails to show clinical benefit.
• Madrigal estimates a market opportunity of $15 billion for Resmetirom, with no current competition in the market.
• That competition may arrive soon, however, in the form of Lilly's all-conquering GLP-1 agonist tirzepatide.
• There are other competitors and Rezdiffra is by no means a perfect drug, but its first mover advantage does give the company an exciting opportunity to dictate market dynamics.

Investment Overview

Considered to be one of the most lucrative untapped markets in healthcare for decades, which has seen multiple Big Pharma concerns, and scores of biotech companies try, and ultimately fail, to persuade the Food and Drug Agency to approve its drugs in the indication, Madrigal Pharmaceuticals ( MDGL ), the West Conshohocken, Pennsylvania based biotech, can now officially be declared the winner of the "NASH Dash".

More of a marathon than a "dash", a race which has lasted so long the disease target, nonalcoholic steatohepatitis, has undergone a name change, to metabolic dysfunction-associated steatohepatitis, or "MASH" for short, is now over....

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