BridgeBio BBP-418 Phase 3 Data Shows Cardiac Marker Normalization, Supports Disease Modification

BridgeBio reported new cardiac data from the Phase 3 FORTIFY trial of BBP-418 in LGMD2I/R9. At Month 12, 100% of treated patients with elevated HS troponin I returned to normal versus 40% on placebo. LVEF stabilized or improved in 54% of treated patients versus 25% on placebo. Glycosylated alpha-DG was restored to asymptomatic carrier levels. BBP-418 is under FDA Priority Review with a PDUFA date of November 27, 2026.