{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-039463","form_type":"8-K","ticker":"BBIO","cik":"0001743881","company_name":"BridgeBio Pharma, Inc.","filed_at":"2025-10-27T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.317753+00:00","generated_at":"2026-05-17T02:12:15.198248+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"BridgeBio Phase 3 FORTIFY study hits all primary and secondary endpoints for BBP-418 in LGMD2I/R9","bullets":["Primary endpoint: glycosylated αDG increased 1.8x from baseline at 3 months (p<0.0001); sustained at 12 months.","Serum CK (muscle damage marker) reduced by 82% from baseline vs placebo at 12 months (p<0.0001).","100-meter walk test velocity improved 0.27 m/s vs placebo at 12 months (p<0.0001).","FVC pulmonary function improved ~5% predicted volume vs placebo at 12 months (p=0.0071).","Company plans to file NDA with FDA in first half 2026; safety profile consistent with prior studies."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-039463","json":"https://secwatch.observer/filing/0001140361-25-039463.json","markdown":"https://secwatch.observer/filing/0001140361-25-039463.md","text":"https://secwatch.observer/filing/0001140361-25-039463.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036125039463/0001140361-25-039463-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036125039463/ef20057750_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T02:12:15.198248+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"}