secwatch.observer — SEC 8-K summary
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Issuer:     CG Oncology, Inc. (CGON)
CIK:        0001991792
Form:       8-K
Filed at:   2026-01-09T23:59:59+00:00
Accession:  0001193125-26-008329
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

CG Oncology Accelerates PIVOT-006 Phase 3 Data Readout to 1H 2026 and Reports Positive Cretostimogene Results
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- 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.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1991792/000119312526008329/0001193125-26-008329-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1991792/000119312526008329/ck0001991792-20260109.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-008329

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer