Gilead's Livdelzi Shows Sustained ALP Normalization in PBC Patients

Event summary

  • Gilead's Livdelzi (seladelpar) achieved 74% sustained ALP normalization in PBC patients with ALP 1–1.67×ULN at 24 months.
  • 83% of evaluable participants achieved composite ALP normalization at 12 months in the Phase 3 ASSURE study.
  • Data presented at EASL Congress 2026 highlights Livdelzi's potential for broader PBC patient populations.
  • Livdelzi maintained a favorable safety profile with no new adverse events observed over two years.

The big picture

Gilead's Livdelzi is emerging as a key player in the PBC treatment landscape, addressing a significant unmet need for patients who do not achieve ALP normalization with first-line therapies. The sustained efficacy and safety data from the ASSURE study strengthen its position in a market where long-term disease control is critical. These results come at a time when the PBC treatment paradigm is evolving, with increasing emphasis on biochemical normalization as a surrogate for improved clinical outcomes.

What we're watching

Regulatory Pathway
Whether Gilead can leverage these data to expand Livdelzi's approved indications or gain broader market access.
Competitive Positioning
How these results position Livdelzi against existing and emerging PBC therapies in terms of efficacy and safety.
Commercial Strategy
The pace at which Gilead can translate these findings into market adoption, particularly among patients with lower ALP levels.