{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-011991","form_type":"8-K","ticker":"BBIO","cik":"0001743881","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-03-30T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.056259+00:00","generated_at":"2026-05-15T08:24:36.913429+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 submits NDA to FDA for BBP-418 for LGMD2I/R9; potential first approved therapy","bullets":["NDA submission for oral BBP-418 in limb-girdle muscular dystrophy type 2I/R9.","Phase 3 FORTIFY interim analysis met all primary and secondary endpoints at 12 months.","FDA approval and U.S. launch anticipated in late 2026 / early 2027.","BBP-418 has Orphan Drug, Fast Track, and Rare Pediatric Disease designations from FDA.","Company also engaging European regulators for expedited approval path."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-011991","json":"https://secwatch.observer/filing/0001140361-26-011991.json","markdown":"https://secwatch.observer/filing/0001140361-26-011991.md","text":"https://secwatch.observer/filing/0001140361-26-011991.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126011991/0001140361-26-011991-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126011991/ef20069329_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T08:24:36.913429+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"}