{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-268331","form_type":"8-K","ticker":"VERA","cik":"0001831828","company_name":"Vera Therapeutics, Inc.","filed_at":"2025-11-06T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.688033+00:00","generated_at":"2026-05-16T23:58:17.628918+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Vera Therapeutics announces atacicept Phase 3 data: 46% proteinuria reduction, 42% vs placebo (p<0.0001)","bullets":["Atacicept achieved 46% reduction from baseline in UPCR at week 36; 42% reduction vs placebo (p<0.0001).","Secondary endpoints: Gd-IgA1 reduced by 68%; hematuria resolved in 81% of participants with baseline hematuria.","Safety profile favorable: serious adverse events 0.5% (atacicept) vs 5% (placebo); no deaths in either group.","eGFR results not disclosed per FDA recommendation to sponsors of IgAN registrational trials.","Data presented at ASN Kidney Week and simultaneously published in The New England Journal of Medicine."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-268331","json":"https://secwatch.observer/filing/0001193125-25-268331.json","markdown":"https://secwatch.observer/filing/0001193125-25-268331.md","text":"https://secwatch.observer/filing/0001193125-25-268331.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1831828/000119312525268331/0001193125-25-268331-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1831828/000119312525268331/d30094d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T23:58:17.628918+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":"0001193125-26-252718","ticker":"QMCO","company_name":"QUANTUM CORP /DE/","filed_at":"2026-06-02T14:41:23+00:00","headline":"Quantum raises $100M equity, converts all convertible notes to equity; Q4 revenue above guidance","event_type":"other_material","sec_items":["1.01","2.02","2.03","3.02","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: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-252718","json":"https://secwatch.observer/filing/0001193125-26-252718.json","markdown":"https://secwatch.observer/filing/0001193125-26-252718.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/709283/000119312526252718/0001193125-26-252718-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/709283/000119312526252718/d35173d8k.htm"},"side_by_side_evidence":null},{"accession":"0001493152-26-026761","ticker":"CELC","company_name":"Celcuity Inc.","filed_at":"2026-06-02T12:10:25+00:00","headline":"Gedatolisib doubles PFS vs alpelisib in PIK3CA mutant HR+/HER2- ABC Phase 3 trial","event_type":"other_material","sec_items":["7.01","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: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-026761","json":"https://secwatch.observer/filing/0001493152-26-026761.json","markdown":"https://secwatch.observer/filing/0001493152-26-026761.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/0001493152-26-026761-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1603454/000149315226026761/form8-k.htm"},"side_by_side_evidence":null},{"accession":"0001193125-26-251399","ticker":"IDYA","company_name":"IDEAYA Biosciences, Inc.","filed_at":"2026-06-01T20:05:32+00:00","headline":"IDEAYA's darovasertib combo meets primary endpoint in Phase 2/3 OptimUM-02 trial for metastatic uveal melanoma","event_type":"other_material","sec_items":["7.01","8.01","9.01"],"materiality_score":0.8,"calibrated_materiality_score":0.8,"match_reasons":["same SEC item: 8.01, 9.01","same event type: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-251399","json":"https://secwatch.observer/filing/0001193125-26-251399.json","markdown":"https://secwatch.observer/filing/0001193125-26-251399.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1676725/000119312526251399/0001193125-26-251399-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1676725/000119312526251399/d138848d8k.htm"},"side_by_side_evidence":null},{"accession":"0001193125-26-251394","ticker":"FULC","company_name":"Fulcrum Therapeutics, Inc.","filed_at":"2026-06-01T20:05:16+00:00","headline":"Fulcrum Therapeutics discontinues pociredir program in SCD; initiates strategic review","event_type":"other_material","sec_items":["8.01","9.01"],"materiality_score":0.8,"calibrated_materiality_score":0.8,"match_reasons":["same SEC item: 8.01, 9.01","same event type: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-251394","json":"https://secwatch.observer/filing/0001193125-26-251394.json","markdown":"https://secwatch.observer/filing/0001193125-26-251394.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1680581/000119312526251394/0001193125-26-251394-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1680581/000119312526251394/fulc-20260601.htm"},"side_by_side_evidence":null},{"accession":"0001213900-26-063832","ticker":"USAR","company_name":"USA Rare Earth, Inc.","filed_at":"2026-06-02T13:14:30+00:00","headline":"USA Rare Earth selects South Carolina for $1.2B magnet facility; 490 jobs, 6,400 tpa capacity","event_type":"other_material","sec_items":["1.01","2.03","7.01","9.01"],"materiality_score":0.8,"calibrated_materiality_score":0.8,"match_reasons":["same SEC item: 9.01","same event type: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-063832","json":"https://secwatch.observer/filing/0001213900-26-063832.json","markdown":"https://secwatch.observer/filing/0001213900-26-063832.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1970622/000121390026063832/0001213900-26-063832-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1970622/000121390026063832/ea0293127-8k_usarare.htm"},"side_by_side_evidence":null},{"accession":"0001104659-26-069246","ticker":"SHAK","company_name":"Shake Shack Inc.","filed_at":"2026-06-02T12:06:18+00:00","headline":"Shake Shack cuts Q2 revenue guidance to $415-420M, same-shack sales to 2.5-3.0%","event_type":"other_material","sec_items":["7.01","9.01"],"materiality_score":0.8,"calibrated_materiality_score":0.8,"match_reasons":["same SEC item: 9.01","same event type: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-069246","json":"https://secwatch.observer/filing/0001104659-26-069246.json","markdown":"https://secwatch.observer/filing/0001104659-26-069246.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1620533/000110465926069246/0001104659-26-069246-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1620533/000110465926069246/tm2616608d1_8k.htm"},"side_by_side_evidence":null},{"accession":"0001750155-26-000080","ticker":"CWBHF","company_name":"Charlotte's Web Holdings, Inc.","filed_at":"2026-06-01T21:13:23+00:00","headline":"Charlotte's Web appoints BAT GC to board, closes debt conversion & US$10M investment","event_type":"other_material","sec_items":["5.02","5.07","8.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 8.01","same event type: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001750155-26-000080","json":"https://secwatch.observer/filing/0001750155-26-000080.json","markdown":"https://secwatch.observer/filing/0001750155-26-000080.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1750155/000175015526000080/0001750155-26-000080-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1750155/000175015526000080/cweb-20260528.htm"},"side_by_side_evidence":null},{"accession":"0001213900-26-063486","ticker":"MDAI","company_name":"Spectral AI, Inc.","filed_at":"2026-06-01T20:01:42+00:00","headline":"Spectral AI gets FDA clearance for DeepView burn indication; targets first commercial sales by year-end 2026","event_type":"other_material","sec_items":["5.07","7.01","9.01"],"materiality_score":0.85,"calibrated_materiality_score":0.85,"match_reasons":["same SEC item: 9.01","same event type: other_material","similar materiality"],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-063486","json":"https://secwatch.observer/filing/0001213900-26-063486.json","markdown":"https://secwatch.observer/filing/0001213900-26-063486.md","edgar_index":"https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/0001213900-26-063486-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1833498/000121390026063486/ea0292962-8k_spectral.htm"},"side_by_side_evidence":null}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}