FDA accepts NDA for BBP-418 with Priority Review; PDUFA Nov 27, 2026

BridgeBio Pharma, Inc.

FDA accepted NDA with Priority Review for BBP-418 to treat LGMD2I/R9; PDUFA target action date November 27, 2026.
No advisory committee meeting currently planned for the application.
Phase 3 FORTIFY trial met all primary and secondary endpoints; treated patients improved while placebo declined.
If approved, BBP-418 would be first and only therapy for LGMD2I/R9 and first approved treatment for any form of LGMD.
BridgeBio plans to start studies in patients under 12 years and in LGMD2M/R13 and LGMD2U/R20.

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