Inventiva Revises Phase III NASH Plans For Broader Indication
While plans to obtain accelerated approval of lanifibranor remain unchanged, Inventiva now plans to conduct the confirmatory Phase III in cirrhotic patients, meaning a shorter trial duration and possibly broader label.
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Madrigal Phase III Success In NASH Spurs Buyout Speculation
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.
NASH Drug Development Questions? US FDA Has Many Of The Answers
From biomarkers to treatment effect size, agency officials respond to some of more than a hundred questions that poured in during a webinar on development of drugs to treat the liver disease.
Year Of NASH Upheaval Means Incremental Data At AASLD
With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.