---
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"
generated_at: "2026-05-16T11:07:05.900393+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-008329
- JSON: https://secwatch.observer/filing/0001193125-26-008329.json
- Plain text: https://secwatch.observer/filing/0001193125-26-008329.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.