Sundry Photography Gilead Sciences ( NASDAQ: GILD ) said that interim results from an open-label trial of seladelpar, its candidate for the liver disease primary biliary cholangitis, led to improvements in markers of cholestasis and reduced inflammation. Results from the ASSURE study showed that 70% of 148 patients who finished a year of treatment met the clinically meaningful composite response endpoint. Among those on seladelpar, 37% experienced mean alkaline phosphatase (ALP) normalization, with a mean ALP change from baseline of -44%.
Of 20 patients who completed 24 months of treatment, 70% achieved the composite response endpoint and 25% saw ALP normalization. The U.S.
FDA is slated to act on Gilead's ( GILD ) application by Aug. 14. Gilead gained seladelpar through its $4.
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