Mirum's volixibat meets Phase 2b endpoint in PSC, plans H2 2026 NDA submission

Filed May 4, 2026 · Period ending May 4, 2026 · ~1 min read

Key Changes

• high

  Volixibat achieved statistically significant 1.64-point improvement over placebo (p<0.0001) in cholestatic pruritus among 111 PSC patients with moderate-to-severe itch, supporting potential first-in-class treatment claim.

  Item 8.01 — Other Events verify on EDGAR →
• high

  Pre-NDA meeting scheduled with FDA for summer 2026, with New Drug Application submission planned for second half of 2026, representing near-term regulatory milestone.

  Item 8.01 — Other Events verify on EDGAR →
• high

  Safety profile showed 40.3% diarrhea rate versus 8.6% placebo, with 9.1% premature discontinuation versus 2.5% placebo; gastrointestinal events and liver enzyme elevations consistent with IBAT inhibition mechanism.

  Item 8.01 — Other Events verify on EDGAR →