---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-029291"
form_type: "8-K"
ticker: "BBIO"
cik: "0001743881"
company_name: "BridgeBio Pharma, Inc."
filed_at: "2026-07-22T20:34:14+00:00"
generated_at: "2026-07-22T20:35:08.323833+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# BridgeBio announces FDA acceptance of NDA for encaleret in ADH1; PDUFA date May 8, 2027

## Summary
- FDA accepted NDA for encaleret for ADH1; PDUFA target action date May 8, 2027; no advisory committee planned.
- Encaleret met all primary and key secondary endpoints in Phase 3 CALIBRATE trial, normalizing CaSR-driven markers.
- Over 2,100 ADH1 patients diagnosed in U.S. since Oct 2023; BridgeBio plans MAA submission to EMA in H2 2026.
- Company also enrolling pediatric Phase 2/3 (CALIBRATE-PEDS) and plans Phase 3 in chronic hypoparathyroidism (RECLAIM-HP).

## SEC filing metadata
- accession: 0001140361-26-029291
- form_type: 8-K
- ticker: BBIO
- cik: 0001743881
- company_name: BridgeBio Pharma, Inc.
- filed_at: 2026-07-22T20:34:14+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1743881/000114036126029291/0001140361-26-029291-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1743881/000114036126029291/ef20078442_form8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-029291
- JSON: https://secwatch.observer/filing/0001140361-26-029291.json
- Plain text: https://secwatch.observer/filing/0001140361-26-029291.txt

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