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CONSHOHOCKEN, Pa. - Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), currently valued at $6.9 billion, announced Wednesday that the United States Patent and Trademark Office has issued a Notice of Allowance covering the FDA-approved use of Rezdiffra (resmetirom), its treatment for adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. According to InvestingPro data, the company maintains a strong financial position with more cash than debt on its balance sheet.
The patent, which provides protection through September 30, 2044, includes claims directed to Rezdiffra’s commercial weight-threshold dosing regimen as prescribed in the FDA-approved label. It will be listed in the FDA’s Orange Book, officially known as the Approved Drug Products with Therapeutic Equivalence Evaluations.
"This issuance marks a pivotal milestone in our long-term Rezdiffra strategy," said Bill Sibold, Chief Executive Officer of Madrigal, according to the company’s press release.
Rezdiffra is the first and only FDA-approved treatment for MASH with moderate to advanced fibrosis (stages F2 to F3). The once-daily, oral medication is a liver-directed THR-β agonist designed to target underlying causes of the disease.
The company is currently conducting a Phase 3 outcomes trial evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (stage F4c).
MASH, previously known as nonalcoholic steatohepatitis (NASH), is a liver disease with significant unmet medical needs.
The information in this article is based on a press release statement from Madrigal Pharmaceuticals.
In other recent news, Madrigal Pharmaceuticals reported that the U.S. launch of its drug Rezdiffra has surpassed expectations, with over 17,000 patients using the drug, leading to sales exceeding consensus estimates. The company is preparing for the European launch of Rezdiffra, with a regulatory decision anticipated in August. The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of resmetirom, marketed as Rezdiffra, for treating noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. This follows the U.S. FDA’s accelerated approval earlier this year. Analyst firms have weighed in on Madrigal’s prospects; Citizens JMP maintained a Market Outperform rating with a price target of $470, while Citi reaffirmed a Buy rating with a $456 target. Conversely, BofA Securities maintained an Underperform rating with a $248 target, citing uncertainties in assessing Rezdiffra’s overall benefit. Madrigal continues to engage the medical community with upcoming presentations and discussions on Rezdiffra’s potential, including at a medical conference where it will be compared with other treatments. These developments reflect ongoing interest and varying perspectives on the company’s drug and its market potential.
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