Madrigal Pharmaceuticals Inc. (NASDAQ:MDGL) saw its stock climb 6.1% following the announcement that the U.S. Patent and Trademark Office has issued a Notice of Allowance for its MASH treatment, Rezdiffra.
The patent safeguards the FDA-approved use of Rezdiffra (resmetirom), the first and only FDA-approved therapy for adults suffering from noncirrhotic MASH with moderate to advanced liver fibrosis. This patent protection is set to last until September 30, 2044, and will be included in the FDA’s Orange Book.
The Notice of Allowance covers claims related to Rezdiffra’s commercial dosing regimen based on weight thresholds, as specified in the FDA-approved label. MASH, also called NASH (non-alcoholic steatohepatitis), represents a critical market given its severity and the limited treatment options before Rezdiffra’s approval.
“This issuance marks a pivotal milestone in our long-term Rezdiffra strategy,” said Bill Sibold, Chief Executive Officer of Madrigal. “It recognizes the value of our pioneering clinical development program and will allow our team to continue driving innovation for patients with MASH for years to come.”
This extended patent protection bolsters Madrigal’s competitive edge by blocking generic alternatives for over twenty years, potentially ensuring sustained revenue for the company’s flagship drug.
Madrigal Pharmaceuticals stock price
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