Mirum's Brelovitug Hits Phase 3 Primary Endpoint in Chronic Hepatitis Delta; Eyes 2027 BLA Filing

Mirum Pharmaceuticals Inc. (MIRM) said brelovitug met its primary endpoint in the Phase 3 portion of the AZURE-1 study in chronic hepatitis delta virus (HDV), a milestone toward U.S. regulatory submission. The trial achieved virologic response and alanine aminotransferase (ALT) normalization at Week 24 in both dose arms. The 48-week Phase 2b data showed deeper viral suppression, with more patients reaching very low or undetectable HDV RNA levels and higher ALT normalization rates. No new safety signals emerged. Brelovitug, a fully human monoclonal antibody targeting hepatitis B surface antigen, holds FDA Breakthrough Therapy designation and is being developed as a single-agent therapy for chronic HDV. Mirum expects topline Phase 3 AZURE-4 results later in 2026 and plans a Biologics License Application in the first half of 2027, with AZURE-1 and AZURE-4 forming its U.S. registration package. MIRM traded at $88.39, down 1.47%, within a 52-week range of $63.23 to $130.00.