---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-021036"
form_type: "8-K"
ticker: "BBIO"
cik: "0001743881"
company_name: "BridgeBio Pharma, Inc."
filed_at: "2026-05-13T20:01:37+00:00"
generated_at: "2026-05-13T22:24:51.001426+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# BridgeBio submits NDA to FDA for encaleret in ADH1; Phase 3 data shows 76% achieved target calcium levels

## Summary
- NDA submitted for encaleret, a potential first approved therapy for autosomal dominant hypocalcemia type 1 (ADH1).
- Phase 3 CALIBRATE trial met all primary and key secondary endpoints: 76% on encaleret vs 4.4% on standard of care achieved both serum and urine calcium targets at Week 24 (p<0.0001).
- BridgeBio anticipates U.S. launch in early 2027; NDA may be eligible for priority review.
- Planned MAA submission to EMA in H2 2026; also plans to initiate RECLAIM-HP Phase 3 study in chronic hypoparathyroidism in Summer 2026.
- Safety profile favorable: no discontinuations in encaleret arm; low rates of serious adverse events similar between arms.

## SEC filing metadata
- accession: 0001140361-26-021036
- form_type: 8-K
- ticker: BBIO
- cik: 0001743881
- company_name: BridgeBio Pharma, Inc.
- filed_at: 2026-05-13T20:01:37+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/1743881/000114036126021036/0001140361-26-021036-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/ef20073370_form8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-021036
- JSON: https://secwatch.observer/filing/0001140361-26-021036.json
- Plain text: https://secwatch.observer/filing/0001140361-26-021036.txt

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