{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-008329","form_type":"8-K","ticker":"CGON","cik":"0001991792","company_name":"CG Oncology, Inc.","filed_at":"2026-01-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:36.944500+00:00","generated_at":"2026-05-16T11:07:05.900393+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"confidence":"high","headline":"CG Oncology Accelerates PIVOT-006 Phase 3 Data Readout to 1H 2026 and Reports Positive Cretostimogene Results","bullets":["PIVOT-006 topline data for cretostimogene in intermediate-risk NMIBC now expected in first half of 2026, nearly one year ahead of schedule.","BOND-003 Cohort P showed 95.7% HG-EFS at 3 months, 84.6% at 6 months, and 80.4% at 9 months; no Grade 3+ TRAEs or deaths.","CORE-008 Cohort A (BCG-naïve high-risk NMIBC with CIS) achieved 83.7% overall CR rate (79.2% original, 88.0% optimized administration).","No patients in BOND-003 or CORE-008 progressed to MIBC or underwent radical cystectomy; safety profile favorable.","IR NMIBC population in the US estimated over 50,000 patients; no FDA-approved therapies currently exist for adjuvant setting."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-008329","json":"https://secwatch.observer/filing/0001193125-26-008329.json","markdown":"https://secwatch.observer/filing/0001193125-26-008329.md","text":"https://secwatch.observer/filing/0001193125-26-008329.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1991792/000119312526008329/0001193125-26-008329-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1991792/000119312526008329/ck0001991792-20260109.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-16T11:07:05.900393+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"}