MDGL wins EU nod for Rezdiffra as the first and only approved MASH therapy. The drug's launch in Europe is expected in the fourth quarter of 2025.
Rezdiffra's Q2 '25 net sales surged 55% to $212.8M, beating expectations and highlighting strong commercial momentum for Madrigal Pharmaceuticals, Inc. Despite robust revenue growth, Madrigal Pharmaceuticals still reported a net loss of $42.3M, though profitability may be near. Approval of Rezdiffra in the EU could come in August 2025, with a launch by MDGL in Germany in H2 '25 possible.
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL ) Q2 2025 Earnings Conference Call August 5, 2025 8:00 AM ET Company Participants David Soergel - Executive VP & Chief Medical Officer Mardi C. Dier - Executive VP & CFO Tina E.
Madrigal (MDGL) came out with a quarterly loss of $1.9 per share versus the Zacks Consensus Estimate of a loss of $3.48. This compares to a loss of $7.1 per share a year ago.
Madrigal Pharmaceuticals, Inc.'s Rezdiffra showed strong Q1 2025 sales of $137.3M that highlight robust U.S. demand and early commercial momentum in non-cirrhotic NASH patients. Key catalysts include potential European approval in August 2025, label expansion to compensated MASH cirrhosis 2027, and new GLP-1 combo therapy trial initiation in 2026. The global license for SYH2086 aims to boost Rezdiffra's efficacy in MASH, with phase 1 combo trials expected to start in 1st half of 2026.
Madrigal Pharmaceuticals stock jumps 11% after securing a new U.S. patent for Rezdiffra's dosing, reinforcing exclusivity through 2044.
Madrigal (MDGL) was a big mover last session on higher-than-average trading volume. The latest trend in earnings estimate revisions might not help the stock continue moving higher in the near term.
Madrigal Pharmaceuticals' Rezdiffra for NASH achieved $137.3M in Q1 '25 sales, surpassing analyst estimates and indicating strong growth, but the stock hasn't rallied. Near-term catalysts include potential approval of Rezdiffra in Europe, Q2 '25 earnings and business development, with MDGL indicating they are keen to add to their pipeline. Results from the MAESTRO-NASH OUTCOMES trial are not expected until 2027, but recent data from MAESTRO-NAFLD-1 provide some hint of the potential efficacy of Rezdiffra in some patients with cirrhosis.
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL ) Q1 2025 Earnings Conference Call May 1, 2025 8:00 AM ET Company Participants Tina Ventura - Chief Investor Relations Officer Bill Sibold - Chief Executive Officer and Director Mardi Dier - Chief Financial Officer Conference Call Participants Eliana Merle - UBS Andrea Newkirk - Goldman Sachs Ritu Baral - TD Cowen Akash Tewari - Jefferies Yasmeen Rahimi - Piper Sandler Liisa Bayko - Evercore Jay Olson - Oppenheimer Mayank Mamtani - B. Riley Securities Prakhar Agrawal - Cantor Fitzgerald Operator Good day, and thank you for standing by.
MDGL stock is rising as it reports better-than-expected first-quarter results, beating earnings and revenue estimates, driven by strong Rezdiffra sales.
Madrigal (MDGL) came out with a quarterly loss of $3.32 per share versus the Zacks Consensus Estimate of a loss of $3.62. This compares to loss of $7.38 per share a year ago.
Madrigal (MDGL) reported earnings 30 days ago. What's next for the stock?