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Monday, September 28, 2026

Mirum, Incyte win FDA approval for Atebrioz (zilurgisertib) for fibrodysplasia ossificans progressiva

 

Mirum, Incyte win FDA approval for Atebrioz (zilurgisertib) to treat fibrodysplasia ossificans progressiva

  • Atebrioz (zilurgisertib) approved to treat fibrodysplasia ossificans progressiva in adults and children.
  • Phase 3 AZURE-1 trial of brelovitug in chronic hepatitis delta virus met its primary endpoint.
  • AZURE-1 results support Mirum's plans for a U.S. BLA submission in the first half of 2027.
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