secwatch.observer — SEC 8-K summary
======================================

Issuer:     CG Oncology, Inc. (CGON)
CIK:        0001991792
Form:       8-K
Filed at:   2024-05-03T23:59:59+00:00
Accession:  0001193125-24-130800
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

CG Oncology Phase 3 BOND-003: cretostimogene achieves 75.2% complete response in high-risk NMIBC
--------------------------------------------------------------------------------

- 75.2% complete response (79/105 patients; 95% CI: 65-83) at any time in BCG-unresponsive high-risk NMIBC.
- 29 patients maintained CR for ≥12 months; median duration of response not reached as of April 1, 2024.
- 92.4% cystectomy-free-survival; no CR patient had radical cystectomy or nodal/metastatic progression.
- No Grade 3+ TRAEs; 1.8% serious TRAEs (Grade 2 cystitis, clot retention); no treatment discontinuations.
- Topline data from fully enrolled Phase 3 BOND-003 expected by end of 2024.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1991792/000119312524130800/0001193125-24-130800-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1991792/000119312524130800/d823423d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-130800

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