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Mirum reports brelovitug met primary endpoint in Phase 3 AZURE-4 study for chronic hepatitis delta
MIRMMirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals announced that its investigational drug brelovitug met the primary endpoint in the Phase 3 AZURE-4 study for treating chronic hepatitis delta virus (HDV). At Week 24, 59% of patients receiving 300 mg weekly and 44% receiving 900 mg every four weeks achieved a combined endpoint of virologic response and ALT normalization, compared to 0% in the delayed-treatment arm. The company plans to submit a Biologics License Application (BLA) to the FDA in the first half of 2027, with a potential U.S. commercial launch in the fourth quarter of 2027 if approved. Mirum Pharmaceuticals operates as a biopharmaceutical company focused on developing treatments for liver diseases.