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Monday, May 4, 2026

Mirum's Phase 2b VISTAS trial of volixibat in PSC meets primary pruritus endpoint

 

Mirum's Phase 2b VISTAS trial of volixibat in PSC meets primary pruritus endpoint with statistically significant benefit

  • Results support a planned U.S. NDA submission for volixibat in primary sclerosing cholangitis in second half 2026.
  • Mirum expects to hold a pre-NDA FDA meeting this summer to discuss the volixibat submission strategy.
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