BridgeBio submits NDA to FDA for BBP-418 for LGMD2I/R9; potential first approved therapy

BridgeBio Pharma, Inc.

NDA submission for oral BBP-418 in limb-girdle muscular dystrophy type 2I/R9.
Phase 3 FORTIFY interim analysis met all primary and secondary endpoints at 12 months.
FDA approval and U.S. launch anticipated in late 2026 / early 2027.
BBP-418 has Orphan Drug, Fast Track, and Rare Pediatric Disease designations from FDA.
Company also engaging European regulators for expedited approval path.

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