Madrigal Solidifies Presumed NASH Lead With 52-Week Data
Full-year findings for resmetirom reported at EASL confirm 16-week data in non-alcoholic steatohepatitis presented in 2020. Analysts say these data continue to de-risk the drug, but more important readouts await.
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Nearly two-and-a-half years after an FDA complete response letter stalled obeticholic acid’s path to the first approval in non-alcoholic steatohepatitis, Intercept refiled its NDA on 23 December.
With resmetirom hitting its co-primary endpoints, Madrigal intends to file the THRβ agonist for approval during H1 2023 in the liver disease, an unmet medical need with blockbuster earnings potential.
Resmetirom, Madrigal’s THRβ agonist, demonstrates safety and tolerability, and succeeds on secondary efficacy endpoints in a study serving as a precursor to the firm’s pivotal Phase III trial.