MIRM

Mirum Pharmaceuticals announced that its Phase III EXPAND study met the primary endpoint for Livmarli (maralixibat) in treating cholestatic pruritus in patients with ultra-rare cholestatic liver diseases. Livmarli showed a 1.81-point improvement in itch severity versus 0.83 for placebo and achieved a 69% reduction in serum bile acids.

The company plans to submit a supplemental new drug application to the FDA in the first half of 2027. Livmarli sales have grown 50.2% year-over-year in the first half of 2026, reaching $242.5 million.

Mirum Pharmaceuticals announced that brelovitug met the primary endpoint in the phase III AZURE-1 study for chronic hepatitis delta virus (HDV) treatment. 56% of patients on 300 mg weekly and 45% on 900 mg every four weeks achieved virologic response and ALT normalization compared to 0% in the delayed-treatment arm.

The drug was well-tolerated with no new safety concerns. Phase III AZURE-4 data are expected in Q4 2026, with a potential BLA submission planned for H1 2027 and commercial launch expected in Q4 2027.