---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-011991"
form_type: "8-K"
ticker: "BBIO"
cik: "0001743881"
company_name: "BridgeBio Pharma, Inc."
filed_at: "2026-03-30T23:59:59+00:00"
generated_at: "2026-05-15T08:24:36.913429+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BridgeBio submits NDA to FDA for BBP-418 for LGMD2I/R9; potential first approved therapy

## Summary
- NDA submission for oral BBP-418 in limb-girdle muscular dystrophy type 2I/R9.
- Phase 3 FORTIFY interim analysis met all primary and secondary endpoints at 12 months.
- FDA approval and U.S. launch anticipated in late 2026 / early 2027.
- BBP-418 has Orphan Drug, Fast Track, and Rare Pediatric Disease designations from FDA.
- Company also engaging European regulators for expedited approval path.

## SEC filing metadata
- accession: 0001140361-26-011991
- form_type: 8-K
- ticker: BBIO
- cik: 0001743881
- company_name: BridgeBio Pharma, Inc.
- filed_at: 2026-03-30T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1743881/000114036126011991/0001140361-26-011991-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1743881/000114036126011991/ef20069329_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-011991
- JSON: https://secwatch.observer/filing/0001140361-26-011991.json
- Plain text: https://secwatch.observer/filing/0001140361-26-011991.txt

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