GILD · News · 20261105N

Regulatory Approval Milestones

GILEAD SCIENCES, INC. · 2026-11-05 · Importance 34 · Surprise 42

Gilead said it will engage global regulatory authorities based on Phase 3 IDEAL results for Livdelzi (seladelpar) in primary biliary cholangitis (PBC). Third-party reporting said the results support seeking broader use beyond the drug’s current scope. In the study, 75.4% of patients with lower alkaline phosphatase elevation achieved composite ALP normalization at week 52; no timing or financial impact of a potential expansion was reported.

Key facts

• Gilead will engage global regulatory authorities based on the Phase 3 IDEAL results. source