Clinical Trial ResultsResmetirom demonstrated encouraging results from the Phase 3 MAESTRO-NASH trial in F2/3 patients, meeting both dual primary endpoints with a consistent safety profile.
Market ExpansionMDGL expects the European Commission decision to potentially make resmetirom the first medication for MASH in the EU, unlocking the next leg of growth for MDGL.
Regulatory ApprovalThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending conditional approval of Rezdiffra for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis.