secwatch.observer — SEC 8-K summary
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Issuer:     BridgeBio Pharma, Inc. (BBIO)
CIK:        0001743881
Form:       8-K
Filed at:   2026-10-13T10:01:35+00:00
Accession:  0001140361-26-039334
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

BridgeBio's oral infigratinib NDA accepted by FDA with Priority Review; PDUFA date Feb 4, 2027
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- FDA accepted for filing the NDA for oral infigratinib in children with achondroplasia under Priority Review, with a PDUFA target action date of February 4, 2027.
- PROPEL 3 Phase 3 met primary endpoint of annualized height velocity at Week 52: LS mean treatment difference +1.74 cm/yr, mean difference +2.10 cm/yr, p<0.0001; height Z-score also significant.
- First therapy to show statistically significant body-proportionality improvement in a randomized achondroplasia trial (mean difference -0.05, ages 3-8, p<0.05); arm span z-score +0.37 SD, p<0.0001.
- Drug was well tolerated with no discontinuations or serious adverse events related to study drug; data published in The New England Journal of Medicine and presented at ICCBH 2026.
- BridgeBio plans an EU Marketing Authorization Application in Q4 2026 and says it is prepared to launch oral infigratinib in the U.S. upon approval.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/0001140361-26-039334-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_form8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-039334

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