Mirum and First Tracks report positive trial results

Mirum Pharmaceuticals said its Phase 3 EXPAND trial of LIVMARLI (maralixibat) met its primary endpoint in patients with cholestatic pruritus linked to ultra-rare liver diseases, including biliary atresia. The 52-person study also met all five prespecified secondary endpoints. Mirum plans to submit results to the FDA in the first half of 2027.

First Tracks Biotherapeutics reported positive top-line results from Cohort 1 of its Phase 1b celiac disease trial of ANB033. In a 32-participant gluten-challenge study, treatment significantly reduced gluten-related intestinal damage versus placebo and helped prevent symptom worsening. No serious treatment-related adverse events were reported.

Both updates are early steps, not proof of regulatory approval:
First Tracks expects data from its second cohort in Q1 2027, while Mirum’s reported results would support a potential label expansion.