CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) reported strong second-quarter results, led by surging demand for Rezdiffra™, its recently launched treatment for metabolic dysfunction-associated steatohepatitis (MASH). The company also outlined a series of strategic milestones aimed at solidifying its leadership in liver disease therapeutics.
Net sales of Rezdiffra reached $212.8 million for the quarter, up sharply from $14.6 million in the same period last year. As of June 30, more than 23,000 patients were on the therapy, according to the company.
“This was another exceptional quarter driven by continued strong Rezdiffra demand,” said CEO Bill Sibold. He credited the growth to Madrigal’s long-term strategy to dominate the MASH market through expanded geographic reach, pipeline development, and robust commercialization.
Patent and Pipeline Expansion
A new U.S. patent for Rezdiffra, expected to be issued today, extends exclusivity to February 4, 2045. The patent protects the drug’s FDA-approved weight-based dosing regimen and will be listed in the FDA’s Orange Book, reinforcing the company’s IP position as it scales distribution.
In July, Madrigal licensed global rights to SYH2086, an oral GLP-1 receptor agonist developed by CSPC Pharma. The compound, an orforglipron derivative, is expected to enter clinical trials in early 2026. The move supports Madrigal’s strategy to build combination therapies for MASH anchored by Rezdiffra.
The company also strengthened its financial position with a new credit facility from Blue Owl Capital, providing up to $500 million in non-dilutive financing. The initial $350 million tranche was used to repay an earlier loan, and an additional $150 million is available through 2027. The deal also includes the option for $250 million in incremental financing for potential business development.
Clinical Progress and Market Outlook
New two-year data from a compensated MASH cirrhosis (F4c) cohort, presented at the EASL Congress in May, showed sustained improvements across a range of liver health indicators. These results support the ongoing MAESTRO-NASH OUTCOMES trial, with pivotal data expected in 2027. If approved, Rezdiffra would become the first approved treatment for F4c MASH patients in the U.S., where the addressable population is estimated at 245,000 individuals.
In Europe, the company received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in June. A final decision from the European Commission is expected in August, which could make Rezdiffra the first MASH therapy approved in the EU.
Financials
Second-quarter operating expenses totaled $260 million, up from $177.2 million a year earlier. The increase was driven primarily by commercial investments in Rezdiffra, including expanded headcount and marketing. R&D spending declined to $54.1 million, down from $71.1 million, reflecting lower clinical trial activity. Selling, general, and administrative (SG&A) expenses nearly doubled year-over-year to $196.9 million.
Madrigal ended the quarter with $802 million in cash and marketable securities, down from $931.3 million at the start of the year, due to funding of operations.
Governance
In August, the company appointed Dan Brennan, former CFO of Boston Scientific, to its Board of Directors, adding further financial expertise to guide its next phase of growth.
As Madrigal continues to scale its lead product and advance its pipeline, the company is positioning itself as a long-term force in the global MASH treatment landscape.
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