secwatch.observer — SEC 8-K summary
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Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2025-10-29T23:59:59+00:00
Accession:  0001140361-25-039705
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BridgeBio reports positive Phase 3 results for encaleret in ADH1; 76% met primary endpoint
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- 76% of encaleret-treated patients achieved both serum and urine calcium targets vs 4% on conventional therapy (p<0.0001).
- 91% on encaleret achieved intact PTH above lower limit vs 7% on conventional therapy (p<0.0001).
- Encaleret was well-tolerated with no discontinuations related to study drug.
- NDA submission to FDA planned H1 2026; EMA submission to follow.
- BridgeBio plans to initiate registrational trials in pediatric ADH1 and chronic hypoparathyroidism in 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036125039705/0001140361-25-039705-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036125039705/ef20057894_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-039705

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer