Bridgebio Pharma Announced It Has Surpassed Its Interim Analysis Enrollment Target For BBP-418 And Expects Topline Interim Data From Its Phase 3 FORTIFY Study For Limb-girdle Muscular Dystrophy Type 2I/R9 In 2025
$BBIO
Biotechnology: Pharmaceutical Preparations
Health Care
- BridgeBio has surpassed its interim analysis enrollment target for its Phase 3 FORTIFY study of BBP-418 in individuals living with LGMD2I/R9, with top-line results from the interim analysis expected in 2025.
- Recent Type C interactions with U.S. Food and Drug Administration (FDA) focused on the validated glycosylated alpha-dystroglycan (αDG) bioassay and our interim analysis plans reinforce BridgeBio's belief that there is potential to pursue Accelerated Approval for BBP-418.
- Rare Pediatric Disease Designation for BBP-418 highlights that LGMD2I/R9 is a rare disease with serious manifestations, which primarily impacts children, and if BBP-418 is approved, BridgeBio may qualify for a Priority Review Voucher.