---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-25-039463"
form_type: "8-K"
ticker: "BBIO"
cik: "0001743881"
company_name: "BridgeBio Pharma, Inc."
filed_at: "2025-10-27T23:59:59+00:00"
generated_at: "2026-05-17T02:12:15.198248+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BridgeBio Phase 3 FORTIFY study hits all primary and secondary endpoints for BBP-418 in LGMD2I/R9

## Summary
- 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.

## SEC filing metadata
- accession: 0001140361-25-039463
- form_type: 8-K
- ticker: BBIO
- cik: 0001743881
- company_name: BridgeBio Pharma, Inc.
- filed_at: 2025-10-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1743881/000114036125039463/0001140361-25-039463-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1743881/000114036125039463/ef20057750_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-25-039463
- JSON: https://secwatch.observer/filing/0001140361-25-039463.json
- Plain text: https://secwatch.observer/filing/0001140361-25-039463.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.