Madrigal Pharmaceuticals' Rezdiffra Surpasses 29,500 Patients, Drives Record Quarterly Sales and Global Expansion

Rezdiffra's Rapid Adoption and Global Growth Are Reshaping MASH Treatment

Madrigal Pharmaceuticals is marking a pivotal moment: its lead therapy, Rezdiffra, notched net sales of $287.3 million in the third quarter of 2025, a leap driven by increased adoption among more than 29,500 patients. With over 10,000 healthcare providers prescribing Rezdiffra and the product’s annualized sales now exceeding $1 billion, Madrigal is setting a new benchmark for specialty therapy launches—while still only tapping a fraction of its addressable population for metabolic dysfunction-associated steatohepatitis (MASH).

Leadership cited strong momentum heading into 2026. CEO Bill Sibold noted, "With greater than 90 percent of our target population yet to be treated, Rezdiffra is poised for significant continued growth." Rezdiffra has recently launched in Germany following European approval and now stands as the only approved therapy for MASH in both the US and the EU.

Pipeline and Patent Protection Set Up Madrigal for the Long Term

Madrigal is making moves to secure its leadership position for years to come. It closed a global licensing deal with CSPC Pharma, adding an oral GLP-1 (MGL-2086) to its pipeline—an asset slated to enter clinical development in early 2026 and positioned for future combination use with Rezdiffra. Management emphasizes a multi-therapy approach will likely define MASH treatment, much like in other complex disease areas.

Intellectual property protection is another bright spot. A new US patent, covering the FDA-approved dosing of Rezdiffra, has been listed in the FDA's Orange Book and provides exclusivity into 2045. This not only secures Madrigal's commercial lead, but also allows for robust, thoughtful investment in additional research and development.

Financial Highlights: Revenue Surge, Strategic Investments, and Solid Cash Reserves

The company's quarterly numbers showcase the effects of Rezdiffra’s launch and commercial build-out. Revenues soared year-over-year, operating expenses increased to fuel expansion and combination-therapy R&D, and Madrigal's cash position remains strong at $1.11 billion. The below table summarizes Madrigal's financial performance for Q3 2025 versus the prior year:

Key Milestones: German Launch, Major Liver Meeting Presence, and Patent News

The momentum isn’t just in numbers. Madrigal’s European rollout is underway, with Rezdiffra already available in Germany post-European Commission approval. The therapy’s effectiveness in reducing fibrosis and resolving MASH has been underscored by pivotal clinical trial results. Rezdiffra’s profile was further bolstered by its new Orange Book-listed patent and a prominent scientific presence—15 abstracts accepted at the American Association for the Study of Liver Diseases (AASLD) meeting, including distinguished oral and poster presentations.

What’s Next for Madrigal?

Madrigal is pressing its first-mover advantage while broadening its clinical ambitions: a Phase 3 trial evaluating Rezdiffra in compensated MASH cirrhosis (F4c) continues to progress, potentially setting the stage for even wider therapeutic adoption. With substantial cash reserves, strengthened intellectual property, and an expanding pipeline, the company is positioned for continued growth even as it ramps commercial and clinical operations.

Investor Perspective: What to Watch

While Madrigal reported an increased net loss as investments scale up, its financials and commercial trajectory paint a story of confidence and long-term vision. Key developments to monitor: progress of the GLP-1 combination program, results from the F4c cirrhosis trial, updates on international launches, and the company's evolving market share in the still underpenetrated MASH population.

With its multi-pronged approach and patent protection extending into the next two decades, Madrigal appears well-positioned to lead in MASH innovation as the field evolves.

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