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Mirum Pharmaceuticals said its Phase 3 AZURE-4 study for brelovitug reached an important goal.

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Mirum's brelovitug met the main goal in its second Phase 3 study, supporting the company's planned U.S. filing. The drug still needs FDA approval, so a launch is not assured.

MIRM · Mirum Pharmaceuticals, Inc.

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This gives Mirum stronger support for seeking U.S. approval, since AZURE-4 is the second of two Phase 3 studies planned for its filing. The study also reported no new safety signals. Brelovitug is still experimental, and Mirum needs FDA approval before it can sell the drug.

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