{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-021036","form_type":"8-K","ticker":"BBIO","cik":"0001743881","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-05-13T20:01:37+00:00","discovered_at":"2026-05-13T20:03:00.785430+00:00","generated_at":"2026-05-13T22:24:51.001426+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 submits NDA to FDA for encaleret in ADH1; Phase 3 data shows 76% achieved target calcium levels","bullets":["NDA submitted for encaleret, a potential first approved therapy for autosomal dominant hypocalcemia type 1 (ADH1).","Phase 3 CALIBRATE trial met all primary and key secondary endpoints: 76% on encaleret vs 4.4% on standard of care achieved both serum and urine calcium targets at Week 24 (p<0.0001).","BridgeBio anticipates U.S. launch in early 2027; NDA may be eligible for priority review.","Planned MAA submission to EMA in H2 2026; also plans to initiate RECLAIM-HP Phase 3 study in chronic hypoparathyroidism in Summer 2026.","Safety profile favorable: no discontinuations in encaleret arm; low rates of serious adverse events similar between arms."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-021036","json":"https://secwatch.observer/filing/0001140361-26-021036.json","markdown":"https://secwatch.observer/filing/0001140361-26-021036.md","text":"https://secwatch.observer/filing/0001140361-26-021036.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/0001140361-26-021036-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126021036/ef20073370_form8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-13T22:24:51.001426+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":[],"comparable_filings":[{"accession":"0001104659-26-068659","ticker":"OTLK","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-06-01T13:15:32+00:00","headline":"Outlook Therapeutics resubmits BLA for ONS-5010 to FDA; Class 1 review, PDUFA in 60 days","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-068659","json":"https://secwatch.observer/filing/0001104659-26-068659.json","markdown":"https://secwatch.observer/filing/0001104659-26-068659.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/0001104659-26-068659-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926068659/tm2616461d1_8k.htm"},"side_by_side_evidence":null},{"accession":"0001178913-26-002988","ticker":"SLXN","company_name":"Silexion Therapeutics Corp","filed_at":"2026-05-29T11:00:25+00:00","headline":"Silexion Therapeutics completes 1-for-10 reverse share split; warrants adjusted","event_type":"regulatory","sec_items":["3.03","5.03","8.01","9.01"],"materiality_score":0.7,"calibrated_materiality_score":0.7,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001178913-26-002988","json":"https://secwatch.observer/filing/0001178913-26-002988.json","markdown":"https://secwatch.observer/filing/0001178913-26-002988.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/2022416/000117891326002988/0001178913-26-002988-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/2022416/000117891326002988/zk2635442.htm"},"side_by_side_evidence":null},{"accession":"0001213900-26-062172","ticker":"RR","company_name":"RICHTECH ROBOTICS INC.","filed_at":"2026-05-28T20:49:32+00:00","headline":"Richtech Robotics receives Nasdaq delisting notice for late Q1 10-Q filing","event_type":"regulatory","sec_items":["3.01","8.01","9.01"],"materiality_score":0.75,"calibrated_materiality_score":0.75,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-062172","json":"https://secwatch.observer/filing/0001213900-26-062172.json","markdown":"https://secwatch.observer/filing/0001213900-26-062172.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1963685/000121390026062172/0001213900-26-062172-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1963685/000121390026062172/ea0292546-8k_richtech.htm"},"side_by_side_evidence":null},{"accession":"0001140361-26-022979","ticker":"BBIO","company_name":"BridgeBio Pharma, Inc.","filed_at":"2026-05-27T20:01:34+00:00","headline":"FDA accepts NDA for BBP-418 with Priority Review; PDUFA Nov 27, 2026","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-022979","json":"https://secwatch.observer/filing/0001140361-26-022979.json","markdown":"https://secwatch.observer/filing/0001140361-26-022979.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/0001140361-26-022979-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1743881/000114036126022979/ef20074977_8k.htm"},"side_by_side_evidence":null},{"accession":"0001193125-26-240645","ticker":"JAGX","company_name":"Jaguar Health, Inc.","filed_at":"2026-05-27T13:10:06+00:00","headline":"Jaguar Health regains Nasdaq Bid Price compliance; monitoring until May 2027","event_type":"regulatory","sec_items":["7.01","8.01","9.01"],"materiality_score":0.7,"calibrated_materiality_score":0.7,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-240645","json":"https://secwatch.observer/filing/0001193125-26-240645.json","markdown":"https://secwatch.observer/filing/0001193125-26-240645.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1585608/000119312526240645/0001193125-26-240645-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1585608/000119312526240645/d129501d8k.htm"},"side_by_side_evidence":null},{"accession":"0001493152-26-025171","ticker":"MBOT","company_name":"Microbot Medical Inc.","filed_at":"2026-05-26T12:30:22+00:00","headline":"Microbot Medical receives Israeli regulatory approval for LIBERTY System, first outside U.S.","event_type":"regulatory","sec_items":["7.01","8.01","9.01"],"materiality_score":0.7,"calibrated_materiality_score":0.7,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-025171","json":"https://secwatch.observer/filing/0001493152-26-025171.json","markdown":"https://secwatch.observer/filing/0001493152-26-025171.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/883975/000149315226025171/0001493152-26-025171-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/883975/000149315226025171/form8-k.htm"},"side_by_side_evidence":null},{"accession":"0001104659-26-065992","ticker":"OTLK","company_name":"Outlook Therapeutics, Inc.","filed_at":"2026-05-26T11:15:41+00:00","headline":"FDA grants Outlook Therapeutics appeal; BLA resubmission planned for June 2026","event_type":"regulatory","sec_items":["8.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-065992","json":"https://secwatch.observer/filing/0001104659-26-065992.json","markdown":"https://secwatch.observer/filing/0001104659-26-065992.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/0001104659-26-065992-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649989/000110465926065992/tm2615583d1_8k.htm"},"side_by_side_evidence":null},{"accession":"0001213900-26-060667","ticker":"LRHC","company_name":"La Rosa Holdings Corp.","filed_at":"2026-05-22T21:20:15+00:00","headline":"La Rosa Holdings receives Nasdaq deficiency notice for late 10-K and 10-Q filings","event_type":"regulatory","sec_items":["3.01","8.01","9.01"],"materiality_score":0.75,"calibrated_materiality_score":0.75,"match_reasons":["same SEC item: 8.01, 9.01","same event type: regulatory","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-060667","json":"https://secwatch.observer/filing/0001213900-26-060667.json","markdown":"https://secwatch.observer/filing/0001213900-26-060667.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1879403/000121390026060667/0001213900-26-060667-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1879403/000121390026060667/ea0291964-8k_larosa.htm"},"side_by_side_evidence":null}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}