Filing Flows › Madrigal Pharmaceuticals (MDGL) › Guidance & outlook
Madrigal Pharmaceuticals (MDGL) guidance and outlook
Madrigal Pharmaceuticals' 10-Q filed Nov 3, 2026 makes 30 forward-looking statements.
Guidance and outlook
Forward-looking statements, 10-Q filed Nov 3, 2026
- Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH.
- We are also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO-NASH OUTCOMES trial, that, if successful, is expected to support the full FDA approval of Rezdiffra for noncirrhotic MASH, and expand the eligible patient population for Rezdiffra with an additional indication in patients with compensated MASH cirrhosis.
- We expect data from the MAESTRO-NASH OUTCOMES trial in late 2027.
- In addition, we plan to initiate an additional Phase 3 trial in compensated MASH cirrhosis.
- Together, we expect data from MAESTRO-NASH OUTCOMES and MAESTRO-CSPH to provide us with the most comprehensive dataset in F4c.
- Pending regulatory discussions, we expect to initiate MAESTRO-CSPH in the first half of 2027 and anticipate results in the early 2030s.
- Through our business development efforts, we have acquired rights to MGL-2086, an oral glucagon-like peptide-1 (“GLP-1”) receptor agonist, ervogastat, an oral diacylglycerol O-acyltransferase 2 (“DGAT-2”) inhibitor, MGL-0795 (formerly ARO-PNPLA3), an siRNA asset targeting a mutation in the patatin-like phospholipase domain-containing protein 3 (“PNPLA3”) gene, six small interfering RNA (“siRNA”) programs and…
- We plan to evaluate these candidates with the goal of delivering best-in-disease therapies for the treatment of MASH.
- As we continue to build our pipeline, we will evaluate mechanisms that fit scientifically, strategically and commercially to enhance our leading position in MASH care.
- MAESTRO-NASH remains ongoing as an outcomes trial where we are generating confirmatory outcomes data to 54-months that, if positive, is expected to verify a clinical benefit and support the full FDA approval of Rezdiffra to treat noncirrhotic MASH.
- We expect outcomes data from MAESTRO-NASH in 2028.
- Based on published epidemiology data and an analysis of medical claims using ICD-10 disease diagnosis codes as of year-end 2023, we estimated that 315,000 patients diagnosed with MASH with moderate to advanced fibrosis (stages F2 to F3) were under the care of specialist prescribers which we are targeting during the launch of Rezdiffra in the U.S.
Madrigal Pharmaceuticals' latest quarter
Madrigal Pharmaceuticals, Q3 2026: revenue $431M (+50% year over year), operating margin 13.0%, net earnings $55.4M, operating cash flow $121M. The chart follows the revenue to costs, profit and cash.
Questions
What does Madrigal Pharmaceuticals expect?
Our medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed thyroid hormone receptor beta (“THR-β”) agonist designed to target key underlying causes of MASH. We are also evaluating Rezdiffra in patients with compensated MASH cirrhosis (consistent with F4c fibrosis) in our MAESTRO-NASH OUTCOMES trial, that, if successful, is expected to support the full FDA approval of Rezdiffra for noncirrhotic MASH, and expand the eligible patient population for Rezdiffra with an additional indication in patients with compensated MASH cirrhosis. We expect data from the MAESTRO-NASH OUTCOMES
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.