other material
confidence high
sentiment positive
materiality 0.85
BridgeBio Phase 3 FORTIFY study hits all primary and secondary endpoints for BBP-418 in LGMD2I/R9
BridgeBio Pharma, Inc.
- Primary endpoint: glycosylated αDG increased 1.8x from baseline at 3 months (p<0.0001); sustained at 12 months.
- Serum CK (muscle damage marker) reduced by 82% from baseline vs placebo at 12 months (p<0.0001).
- 100-meter walk test velocity improved 0.27 m/s vs placebo at 12 months (p<0.0001).
- FVC pulmonary function improved ~5% predicted volume vs placebo at 12 months (p=0.0071).
- Company plans to file NDA with FDA in first half 2026; safety profile consistent with prior studies.