Intercept Gifts Shareholders With NASH Refiling
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.
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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.
While neither company reported new data from their ongoing trials at AASLD, the firm’s competing THRβ agonists are viewed as leading lights in the non-alcoholic steatohepatitis competition.
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