secwatch.observer — SEC 8-K summary
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Issuer:     CG Oncology, Inc. (CGON)
CIK:        0001991792
Form:       8-K
Filed at:   2025-09-05T23:59:59+00:00
Accession:  0001991792-25-000004
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CG Oncology reports 41.8% 24-month CR in Phase 3 BOND-003 for cretostimogene
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- 24-month CR rate of 41.8% (46/110) in BCG-unresponsive HR NMIBC; 12 additional CRs since April 2025 AUA.
- 90% of 12-month responders remained disease-free at 24 months; 96.6% free from progression to muscle-invasive disease.
- No Grade 3+ TRAEs or deaths; median TRAE resolution 1 day; 97.3% completed all treatments.
- Company plans BLA submission for cretostimogene in HR NMIBC unresponsive to BCG in Q4 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1991792/000199179225000004/0001991792-25-000004-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1991792/000199179225000004/ck0001991792-20250905.htm
  HTML page:      https://secwatch.observer/filing/0001991792-25-000004

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