Madrigal Pharmaceuticals (NASDAQ:MDGL) said Rezdiffra continued to post strong commercial growth in the second quarter of 2026, while the company expanded its development pipeline around the MASH therapy and prepared for several potential clinical catalysts.
Speaking at a Canaccord Genuity event, Chief Financial Officer Mardi Dier said the company reported $364 million in second-quarter revenue, representing a 71% increase from the comparable period a year earlier. Rezdiffra’s trailing-12-month revenue run rate was approximately $1.3 billion after nine quarters on the market, she said.
“This is putting us on a trajectory of a mega blockbuster,” Dier said, adding that the company sees Rezdiffra as a long-term growth opportunity in a MASH market that remains early in its development.
Prescriber Base and Competitive Landscape
Chief Commercial Officer Carole Huntsman said Madrigal established a broad group of prescribers early in Rezdiffra’s launch, surpassing 10,000 prescribers last year and continuing to add new prescribers regularly. The company is now focused on increasing prescribing depth, she said.
Huntsman said physicians have reported that Rezdiffra has performed above their expectations in clinical practice, citing its liver-directed efficacy, once-daily oral dosing and tolerability profile. She also pointed to data discussed during the company’s earnings call that showed efficacy across patient subtypes.
Addressing competition, Huntsman said Madrigal has not observed a significant negative impact on Rezdiffra from Wegovy’s approval in MASH. She characterized Wegovy as more of a background therapy, noting that less than 1% of weekly Wegovy prescriptions are written by hepatologists or gastroenterologists for MASH patients, according to the company.
“We welcome competition,” Huntsman said. “Competition helps grow the market” by increasing education among providers and patients.
Pipeline Built Around Rezdiffra Combinations
Madrigal has expanded from a pipeline consisting of Rezdiffra in two indications to a portfolio of 10 assets, Dier said. The company spent less than $300 million upfront to build that pipeline and expects to use the assets primarily in combination with Rezdiffra.
Chief Medical Officer David Soergel outlined the rationale for several programs. MGL-2086, a small-molecule GLP-1 agonist based on an orforglipron scaffold, is intended to deliver modest weight loss that could enhance Rezdiffra’s anti-fibrotic effects. Soergel said data from the MAESTRO-NASH study showed that patients losing 5% of body weight experienced a potentiated effect from resmetirom, Rezdiffra’s active ingredient.
The company has initiated a first-in-human study of MGL-2086 and anticipates starting a combination study with resmetirom in MASH patients next year.
Madrigal also licensed ervogastat, a DGAT-2 inhibitor, from Pfizer. Soergel said Pfizer had advanced the asset through a Phase 2b study and generated evidence of liver-fat reduction in MASH patients. Madrigal expects to begin a Phase 1 drug-drug interaction study later this year, followed by a Phase 2 program next year.
In addition, the company licensed an siRNA targeting PNPLA3 from Arrowhead Pharmaceuticals. Soergel said PNPLA3 is a genetic driver of MASH severity, particularly among Hispanic patients, and that up to 30% of Hispanic patients have mutations that could potentially be addressed through PNPLA3 silencing.
Madrigal expects to have three Phase 2 combination studies beginning next year, subject to discussions with regulators. Soergel said the company will use those data to decide which programs, if any, advance into Phase 3. He stressed that the threshold for advancing a combination is high because Rezdiffra already has broad efficacy and intellectual-property protection through 2045.
Upcoming Studies and International Plans
Soergel said Madrigal has two ongoing Phase 3 studies. The 54-month continuation of MAESTRO-NASH, expected in 2028, is designed to confirm benefit in the F2-F3 population following accelerated approval. A separate event-driven MAESTRO-NASH Outcomes study is evaluating patients with F4 disease.
According to Soergel, positive results from either study could support full approval in F2-F3, while positive F4 outcomes data could support an expanded indication in F4 disease. Huntsman said there are approximately 245,000 diagnosed F4 compensated-cirrhosis patients in the U.S. and that the opportunity could potentially double Rezdiffra’s addressable market across F2 through F4 compensated cirrhosis.
Outside the U.S., Madrigal has received European Union approval, launched in Germany last September and received approval in the U.K., Huntsman said. However, she said sales in Europe will likely remain negligible in 2026 as the company works through reimbursement issues and uncertainty related to the U.S. administration’s most-favored-nation strategy.
About Madrigal Pharmaceuticals (NASDAQ:MDGL)
Madrigal Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the development of innovative therapies for cardiovascular, metabolic and liver diseases. The company’s pipeline centers on novel, liver-directed agents designed to address significant unmet medical needs, with an emphasis on nonalcoholic steatohepatitis (NASH) and related metabolic disorders.
The lead product candidate, resmetirom (MGL-3196), is an orally administered, selective thyroid hormone receptor-β agonist in Phase 3 development for the treatment of NASH.
