Brelovitug - (AZURE)

November 3, 2026: Mirum Pharmaceuticals (NASDAQ: MIRM) reported Q3 2026 results and multiple catalyst updates. ATEBRIOZ (zilurgisertib) received U.S. FDA approval and was launched for reducing total new heterotopic ossification in adult and pediatric FOP patients aged 12+; positive PROGRESS Cohort 2 data were also reported in pediatric patients aged 6 to <12 years, supporting an sNDA planned for H1 2027.

LIVMARLI (maralixibat): the Phase 3 EXPAND study in additional rare cholestatic liver diseases, including biliary atresia, met the primary endpoint and all prespecified secondary endpoints with statistical significance. An sNDA submission is planned for H1 2027.

Brelovitug: the Phase 3 AZURE-1 study in chronic HDV met its primary endpoint, and 48-week Phase 2b AZURE-1 data showed deepening viral suppression and increased ALT normalization. Full AZURE-1 results will be presented at AASLD The Liver Meeting on November 8, 2026 (late-breaking poster at 1:00 p.m. MT; oral presentation at 2:00 p.m. MT). The program also received FDA Orphan Drug Designation in HDV. AZURE-4 Phase 3 topline data are expected in Q4 2026; a BLA submission is planned for H1 2027, subject to supportive AZURE-4 results.

Other upcoming milestones: volixibat VANTAGE Phase 2b topline data in PBC in Q1 2027 and NDA submission in PSC in H1 2027; MRM-3379 BLOOM Phase 2 topline data in FXS in 2027.