{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-029291","form_type":"8-K","ticker":"BBIO","cik":"0001743881","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-07-22T20:34:14+00:00","discovered_at":"2026-07-22T20:35:00.484813+00:00","generated_at":"2026-07-22T20:35:08.323833+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"BridgeBio announces FDA acceptance of NDA for encaleret in ADH1; PDUFA date May 8, 2027","bullets":["FDA accepted NDA for encaleret for ADH1; PDUFA target action date May 8, 2027; no advisory committee planned.","Encaleret met all primary and key secondary endpoints in Phase 3 CALIBRATE trial, normalizing CaSR-driven markers.","Over 2,100 ADH1 patients diagnosed in U.S. since Oct 2023; BridgeBio plans MAA submission to EMA in H2 2026.","Company also enrolling pediatric Phase 2/3 (CALIBRATE-PEDS) and plans Phase 3 in chronic hypoparathyroidism (RECLAIM-HP)."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-029291","json":"https://secwatch.observer/filing/0001140361-26-029291.json","markdown":"https://secwatch.observer/filing/0001140361-26-029291.md","text":"https://secwatch.observer/filing/0001140361-26-029291.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126029291/0001140361-26-029291-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126029291/ef20078442_form8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-22T20:35:08.323833+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"}