---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-022979"
form_type: "8-K"
ticker: "BBIO"
cik: "0001743881"
company_name: "BridgeBio Pharma, Inc."
filed_at: "2026-05-27T20:01:34+00:00"
generated_at: "2026-05-27T20:06:43.574075+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA accepts NDA for BBP-418 with Priority Review; PDUFA Nov 27, 2026

## Summary
- FDA accepted NDA with Priority Review for BBP-418 to treat LGMD2I/R9; PDUFA target action date November 27, 2026.
- No advisory committee meeting currently planned for the application.
- Phase 3 FORTIFY trial met all primary and secondary endpoints; treated patients improved while placebo declined.
- If approved, BBP-418 would be first and only therapy for LGMD2I/R9 and first approved treatment for any form of LGMD.
- BridgeBio plans to start studies in patients under 12 years and in LGMD2M/R13 and LGMD2U/R20.

## SEC filing metadata
- accession: 0001140361-26-022979
- form_type: 8-K
- ticker: BBIO
- cik: 0001743881
- company_name: BridgeBio Pharma, Inc.
- filed_at: 2026-05-27T20:01:34+00:00
- event_type: regulatory
- 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/1743881/000114036126022979/0001140361-26-022979-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/ef20074977_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-022979
- JSON: https://secwatch.observer/filing/0001140361-26-022979.json
- Plain text: https://secwatch.observer/filing/0001140361-26-022979.txt

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