Phase 3 ASSURE Interim Data: Majority of People in the Study with ALP 1–1.67×ULN Achieved High and Sustained Composite ALP Normalization at 24 Months with Gilead’s Livdelzi (Seladelpar)

Phase 3 ASSURE Interim Data: Majority of People in the Study with ALP 1–1.67×ULN Achieved High and Sustained Composite ALP Normalization at 24 Months with Gilead’s Livdelzi (Seladelpar)

– ALP Is a Key Marker of Disease Activity in People Living With PBC, With Elevations Above Normal Associated with Increased Risk of Disease Progression –

– Further Analyses of the Phase 3 ASSURE Study Demonstrate Sustained ALP Normalization and Show Exploratory Outcomes of Stable or Improved Liver Stiffness, Providing Supportive, Long-term Evidence –

Gilead Sciences, Inc. (Nasdaq: GILD) today shared new results from a post hoc analysis showing that Livdelzi® (seladelpar) was associated with high and sustained rates of normalization of a key liver marker (ALP) in people living with primary biliary cholangitis (PBC). In an ongoing Phase 3 study, participants with elevated ALP levels (between 1.0 and 1.67×ULN) experienced reductions in ALP after treatment. These data highlight the potential role of Livdelzi in people with PBC who continue to have elevated ALP despite prior treatment with first-line therapy.

These findings are highly relevant for people living with PBC with inadequately controlled disease based on elevated ALP levels—a population historically underrepresented in randomized clinical trials. The data will be presented at the European Association for the Study of the Liver (EASL) Congress 2026, held May 27–30 in Barcelona, Spain.