Madrigal Pharmaceuticals Inc (MDGL)

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MDGL > 52-week serial liver biopsy Phase 3 study in more than 950 patients, resmetirom achieved both primary endpoints and potentially clinically meaningful effects with both daily oral doses, 80 mg and 100 mg, relative to placebo
NASH resolution (ballooning of 0, inflammation of 0-1) and greater-than or equal to2-point NAS reduction with no worsening of fibrosis (p<0.0001 at both doses)
Fibrosis improvement by at least one stage with no worsening of NAS (p=0.0002 and <0.0001 at 80 and 100 mg, respectively)
Potentially clinically meaningful LDL-lowering, a key secondary endpoint (p<0.0001)
Multiple positive effects on NASH biomarkers and imaging
Resmetirom was safe and well-tolerated in the MAESTRO-NASH study, consistent with the overall safety in Phase 3 MAESTRO trials, expanding the large safety database
Madrigal intends to file a new drug application seeking accelerated approval of resmetirom for the treatment of non-cirrhotic NASH with liver fibrosis