CG Oncology

CG Oncology is a late-stage biopharmaceutical company developing bladder-sparing immunotherapies for patients with urologic cancers. Its lead candidate, cretostimogene grenadenorepvec (formerly CG0070), is an oncolytic immunotherapy delivered directly into the bladder (intravesically) for non-muscle invasive bladder cancer (NMIBC). The company was formerly known as Cold Genesys.

Cretostimogene holds FDA Fast Track and Breakthrough Therapy designations. In the pivotal Phase 3 BOND-003 trial (Cohort C) in high-risk NMIBC that no longer responds to standard BCG treatment, it showed a 41.8% complete response rate at 24 months. The results were published in The Lancet Oncology in July 2026. The company has begun a rolling Biologics License Application (BLA) to the FDA for this indication and expects to complete it in Q4 2026. A Phase 3 trial in intermediate-risk NMIBC, PIVOT-006, has topline results expected soon, and the Phase 2 CORE-008 trial is evaluating patients previously treated with BCG.

CG Oncology went public on Nasdaq (CGON) in January 2024, raising $380M, and is headquartered in Dallas, Texas. Cretostimogene is investigational and not yet approved by any regulatory agency.