Short answer
Mirum Pharmaceuticals, Inc. (MIRM) filed an 8-K current report with the SEC on May 4, 2026 reporting Item 8.01 (Other Events). VISTAS Phase 2b met its primary endpoint in PSC, with placebo-adjusted itch improvement of 1.64 points and p<0.0001.
Mirum Pharmaceuticals, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 8.01 · Other Events
- VISTAS Phase 2b met its primary endpoint in PSC, with placebo-adjusted itch improvement of 1.64 points and p<0.0001
- Volixibat achieved ≥2-point itch reduction in 55.6% versus 26.3% for placebo
- Safety burden elevated: diarrhea 40.3% versus 8.6%, discontinuations 9.1% versus 2.5%
- FDA pre-NDA meeting planned for summer 2026, with NDA submission targeted for the second half of 2026
- VANTAGE Phase 2b topline PBC data now expected in Q1 2027
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