secwatch.observer — SEC 8-K summary
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Issuer:     CG Oncology, Inc. (CGON)
CIK:        0001991792
Form:       8-K
Filed at:   2024-05-24T23:59:59+00:00
Accession:  0000950170-24-064309
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

CG Oncology reports 54% CR at 24 months for cretostimogene combo in NMIBC
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- Phase 2 CORE-001 final results: 54% (19/35) complete response rate at 24 months in BCG-unresponsive HR-NMIBC with CIS.
- Median duration of response exceeds 21 months; 95% of 12-month CR patients maintained CR for another 12 months.
- Progression-free survival at 24 months was 100%; cystectomy-free survival at 24 months was 80% (100% for CR patients).
- No synergistic toxicity observed; combination with pembrolizumab well tolerated.
- FDA Breakthrough Therapy Designation granted in May 2023; company plans to incorporate findings into planned CORE-008 trial.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1991792/000095017024064309/0000950170-24-064309-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1991792/000095017024064309/ck0001991792-20240524.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-064309

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