Madrigal Licenses New GLP-1 Drug to Boost MASH Treatment Pipeline With Once-Daily Oral Combo in Sight

Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) ("Madrigal") today announced that it has entered into an exclusive global license agreement with CSPC Pharmaceutical Group Limited (HKEX Stock CodeL 1093) ("CSPC") for SYH2086, a preclinical oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist and orforglipron derivative. Madrigal plans to initiate clinical development in the first half of 2026.

"We've made remarkable progress this year advancing our strategic priorities – from the continued successful launch of Rezdiffra, to securing new IP protection through 2044, to laying the groundwork for Rezdiffra's next stages of growth in F4c and Europe," said Bill Sibold, Chief Executive Officer of Madrigal. "This agreement to acquire global rights to SYH2086 aligns perfectly with our long-term goal to extend our leadership in MASH by building a pipeline anchored by Rezdiffra. We believe a combination of Rezdiffra and SYH2086 has the potential to deliver a best-in-class oral treatment for patients with MASH."

David Soergel, M.D., Chief Medical Officer of Madrigal, added, "The clinical rationale for developing a combination therapy with Rezdiffra and an oral GLP-1 is clear: we want to optimize efficacy and tolerability in MASH by balancing the weight loss from a GLP-1 with the fibrosis and lipid reduction of Rezdiffra in a once-a-day pill. In the pivotal Phase 3 MAESTRO-NASH trial, even modest weight loss of five percent or more enhanced Rezdiffra's antifibrotic benefit, so we are confident that combination therapy with SYH2086 has the potential to provide increased efficacy for patients with MASH."

"We are pleased to announce the in-license of our oral GLP-1 by Madrigal, an innovative company that pioneered the first approved treatment for MASH," said Dongchen Cai, Chairman of the Board, CSPC. "We believe Madrigal's strong clinical development and commercial capabilities will help unlock the full potential of SYH2086 to benefit patients."