FDA grants priority review to BridgeBio's BBP-418 for treating LGMD2I/R9 with decision due Nov 27, 2026

BridgeBio Pharma announced the FDA has accepted its New Drug Application for BBP-418, an oral therapy for limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9), with a Priority Review and a target action date of November 27, 2026. If approved, BBP-418 would be the first treatment for LGMD2I/R9 and any form of LGMD, addressing a significant unmet medical need. The Phase 3 FORTIFY trial showed BBP-418 improved patient outcomes while placebo patients declined. BridgeBio plans to launch the drug upon approval and is pursuing regulatory approval in Europe as well.