AZURE-4 Phase 3 meets primary endpoint in chronic HDV
Mirum announced that the Phase 3 AZURE-4 study of brelovitug met its primary endpoint at Week 24, with 59% (300 mg QW) and 44% (900 mg Q4W) of patients achieving combined virologic response plus ALT normalization versus 0% in the delayed-treatment arm (p<=0.0001). AZURE-4 is the second of two pivotal studies supporting the U.S. registration package, materially de-risking the brelovitug BLA planned for H1 2027 and likely driving a positive near-term stock reaction.
SEC Filing (8-K)