BBP-418 demonstrates potential to be disease-modifying therapy, restoring cardiac and disease markers to unaffected levels
BBIO•BridgeBio Pharma said BBP-418 met all primary and secondary endpoints at the 12-month interim analysis of its Phase 3 FORTIFY trial. The company said 100% of treated LGMD2I/R9 patients normalized high-sensitivity troponin I at month 12; the drug is under FDA priority review, with a PDUFA date of November 27, 2026.
1. Trial results and review
BridgeBio Pharma said BBP-418 met all primary and secondary endpoints at the 12-month interim analysis of its Phase 3 FORTIFY trial. The company said 100% of treated LGMD2I/R9 patients normalized high-sensitivity troponin I at month 12, and that BBP-418 is under FDA priority review with a PDUFA date of November 27, 2026.
