secwatch.observer — SEC 8-K summary
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Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2023-07-17T23:59:59+00:00
Accession:  0001140361-23-034684
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

BridgeBio Phase 3 acoramidis hits primary endpoint in ATTR-CM; NDA planned by year-end 2023
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- Primary endpoint met with Win Ratio 1.8 (p<0.0001); 81% on-treatment survival vs 74% placebo.
- 50% relative risk reduction (p<0.0001) in frequency of cardiovascular-related hospitalization.
- All secondary endpoints (NT-proBNP, KCCQ, 6-min walk) statistically significant at 30 months (p<0.0001).
- No safety signals identified; NDA submission to FDA targeted by end of 2023.
- Exploratory analysis suggests 42% greater increase in serum TTR vs tafamidis; 92% improvement in median NT-proBNP.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036123034684/0001140361-23-034684-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036123034684/brhc20055953_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-23-034684

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