---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-039334"
form_type: "8-K"
ticker: "BBIO"
cik: "0001743881"
company_name: "BridgeBio Pharma, Inc."
filed_at: "2026-10-13T10:01:35+00:00"
generated_at: "2026-10-13T10:05:44.630056+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# BridgeBio's oral infigratinib NDA accepted by FDA with Priority Review; PDUFA date Feb 4, 2027

## Summary
- FDA accepted for filing the NDA for oral infigratinib in children with achondroplasia under Priority Review, with a PDUFA target action date of February 4, 2027.
- PROPEL 3 Phase 3 met primary endpoint of annualized height velocity at Week 52: LS mean treatment difference +1.74 cm/yr, mean difference +2.10 cm/yr, p<0.0001; height Z-score also significant.
- First therapy to show statistically significant body-proportionality improvement in a randomized achondroplasia trial (mean difference -0.05, ages 3-8, p<0.05); arm span z-score +0.37 SD, p<0.0001.
- Drug was well tolerated with no discontinuations or serious adverse events related to study drug; data published in The New England Journal of Medicine and presented at ICCBH 2026.
- BridgeBio plans an EU Marketing Authorization Application in Q4 2026 and says it is prepared to launch oral infigratinib in the U.S. upon approval.

## SEC filing metadata
- accession: 0001140361-26-039334
- form_type: 8-K
- ticker: BBIO
- cik: 0001743881
- company_name: BridgeBio Pharma, Inc.
- filed_at: 2026-10-13T10:01:35+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/1743881/000114036126039334/0001140361-26-039334-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_form8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-039334
- JSON: https://secwatch.observer/filing/0001140361-26-039334.json
- Plain text: https://secwatch.observer/filing/0001140361-26-039334.txt

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