BridgeBio says Phase 3 FORTIFY data show BBP-418 normalizes HS troponin I by Month 12
BBIO•BridgeBio said 12-month exploratory cardiac data from its Phase 3 FORTIFY trial showed more LGMD2I/R9 patients treated with BBP-418 returned to normal heart-injury blood marker ranges than patients on placebo. BBP-418 is under FDA Priority Review, with a target action date of November 27, 2026.
1. Cardiac data
BridgeBio presented 12-month exploratory cardiac data from its Phase 3 FORTIFY trial of BBP-418 in LGMD2I/R9. Results indicated improvements in heart-injury blood markers, with more treated patients returning to normal ranges than on placebo; more treated patients also showed stable or improved heart pumping function.
2. FDA review
BBP-418 is under FDA Priority Review, with a PDUFA target action date of November 27, 2026.
