Other Events ·
FDA approves Mirum's Atebrioz for fibrodysplasia ossificans progressiva; brelovitug hits Phase 3 endpoint with $1B revenue potential
MIRMMirum Pharmaceuticals, Inc.
Mirum Pharmaceuticals announced FDA approval of Atebrioz (zilurgisertib) for fibrodysplasia ossificans progressiva, with commercial availability expected in October. The company also reported that brelovitug met its primary endpoint in the Phase 3 AZURE-1 study for chronic hepatitis delta, achieving virologic response and ALT normalization in 56% of patients on the 300 mg dose. Mirum estimates annual revenue potential at over $200 million for Atebrioz and more than $1 billion for brelovitug. The company plans to submit a BLA for brelovitug in early 2027 with a potential launch in late 2027. Mirum Pharmaceuticals operates in the biopharmaceutical industry, developing treatments for rare diseases.