{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-039334","form_type":"8-K","ticker":"BBIO","cik":"0001743881","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-10-13T10:01:35+00:00","discovered_at":"2026-10-13T10:05:00.580469+00:00","generated_at":"2026-10-13T10:05:44.630056+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"BridgeBio's oral infigratinib NDA accepted by FDA with Priority Review; PDUFA date Feb 4, 2027","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-039334","json":"https://secwatch.observer/filing/0001140361-26-039334.json","markdown":"https://secwatch.observer/filing/0001140361-26-039334.md","text":"https://secwatch.observer/filing/0001140361-26-039334.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/0001140361-26-039334-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126039334/ef20083591_form8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-13T10:05:44.630056+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}