Mirum's volixibat meets primary endpoint in PSC Phase 2b VISTAS study with statistically significant itch reduction

Mirum Pharmaceuticals, Inc.

Volixibat showed 2.72 point improvement in pruritus vs 1.08 for placebo; placebo-adjusted difference 1.64 (p<0.0001).
55.6% of volixibat patients achieved ≥2 point reduction in Adult ItchRO vs 26.3% for placebo (p=0.0019).
Pre-NDA meeting with FDA scheduled summer 2026; NDA submission planned H2 2026.
VANTAGE Phase 2b study in PBC top-line data now expected Q1 2027.
Most common adverse event was diarrhea (40.3% volixibat vs 8.6% placebo); SAEs in volixibat group not considered related.

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