secwatch.observer — SEC 8-K summary
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Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2026-02-12T23:59:59+00:00
Accession:  0001140361-26-004995
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 infigratinib results in achondroplasia; NDA/MAA planned H2 2026
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- PROPEL 3 met primary endpoint: change from baseline in AHV at Week 52 (p<0.0001); mean treatment difference +2.10 cm/year.
- First statistically significant improvement in body proportionality vs placebo in children <8 years (LS mean -0.05, p<0.05).
- Key secondary endpoint height Z-score (achondroplasia reference) LS mean increase +0.41 SD on treatment (p<0.0001).
- No discontinuations or serious AEs related to study drug; 3 cases (4%) mild transient hyperphosphatemia, no FGFR1/2 AEs.
- NDA and MAA submissions for achondroplasia planned in second half of 2026; accelerate hypochondroplasia development.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126004995/0001140361-26-004995-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126004995/ef20065539_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-004995

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