Gilead’s Liver Disease Drug Shows Sustained Benefits in Long-Term Study

Recent long-term clinical data has reinforced the therapeutic profile of Livdelzi (seladelpar), a treatment for primary biliary cholangitis (PBC) now owned by Gilead Sciences. The drug, which came into Gilead's portfolio following its acquisition of CymaBay Therapeutics, continues to demonstrate durable efficacy in managing this rare liver condition according to the latest research findings.

Gilead Sciences solidified its position in the liver disease therapeutic area in March 2024 by acquiring CymaBay Therapeutics for approximately $4.3 billion, a deal centered on obtaining seladelpar. The strategic move is now being validated by consistent clinical results and a growing list of regulatory approvals across key markets.

Following an accelerated approval from the U.S. Food and Drug Administration (FDA) in August 2024, the drug, marketed as Livdelzi, received conditional marketing authorization from the European Commission in February 2025. Subsequent approvals were granted in the United Kingdom in January 2025 and in Canada in October 2025, underscoring Gilead's successful global rollout.

Extended Data Confirms Durability of Response

Updated findings from the Phase 3 ASSURE study were showcased by Gilead at the American Association for the Study of Liver Diseases (AASLD) Liver Meeting in November 2025. The data indicates that Livdelzi can stabilize or enhance liver health in PBC patients for treatment durations extending to three years.

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Key outcomes from the presentation include:
* Liver Stiffness Measurement (LSM) Stability: 85% of trial participants maintained stable or showed improved LSM scores.
* High-Risk Group Improvement: Patients within the high-risk cohort, defined by a baseline LSM of ≥16.9 kPa, experienced a median reduction of -5.2 kPa, representing a significant 29.7% decrease.
* Symptom Relief: More than half of the patients who began the study with moderate to severe pruritus (itching) reported a substantial alleviation of this burdensome symptom, with the relief persisting for up to 30 months.

Path to Full Regulatory Approval

The accelerated FDA approval granted in 2024 remains contingent upon the outcomes of the ongoing confirmatory trial, named AFFIRM. Gilead's current focus is on completing this study to secure a full, traditional approval from the U.S. regulator.

The accumulating body of positive clinical evidence from multiple studies continues to support the strategic rationale behind Gilead's acquisition and strengthens Livdelzi's potential to become a long-term, cornerstone therapy in its liver disease division.