Mirum completes enrollment in AZURE-1 study, screening in AZURE-4 study

Mirum Pharmaceuticals (MIRM) announced completion of enrollment in the Phase 3 AZURE-1 study and completion of screening in the Phase 3 AZURE-4 study, both evaluating brelovitug for the treatment of chronic hepatitis delta virus. Achievement of these milestones confirms the expected timing of topline 24-week data in the second half of 2026. AZURE-1 and AZURE-4 together will form the basis of Mirum’s U.S. BLA submission for brelovitug, which has received Breakthrough Therapy designation from the FDA for the treatment of chronic HDV infection. Topline data from AZURE-1 and AZURE-4 are expected in 2H 2026, with a potential BLA submission and launch in the U.S. in 2027.