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Madrigal Shares Skyrocket After Successful NASH Study
  • Madrigal Pharmaceuticals Inc MDGL has announced positive topline results from the pivotal Phase 3 MAESTRO-NASH biopsy trial of resmetirom.
  • In the 52-week serial liver biopsy 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 was observed in 26% and 30% in 80 mg and 100 mg doses, respectively, vs. 10% in the placebo.
  • Related: Analysts Believe Madrigal’s Resmetirom Shows Impressive Overall Profile In Liver Fibrosis.
  • Fibrosis improvement by at least one stage with no worsening of NAS at 80 and 100 mg was 24% and 26% vs. 14%.
  • Potentially clinically meaningful LDL-lowering, a key secondary endpoint, was observed at -12% and -16% vs. 1%. Multiple positive effects on NASH biomarkers and imaging.
  • Resmetirom was safe and well-tolerated. Madrigal intends to file a new drug application seeking accelerated approval of resmetirom for non-cirrhotic NASH with liver fibrosis.
  • Price Action: MDGL shares are up 219.6% at $203.89 during the premarket session on the last check Monday.

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