CG Oncology Targets 2026 BLA Filing After 75.5% CR in BOND-003 Cohort
CG Oncology reported a 75.5% complete response rate in its BOND-003 papillary cohort, with 90% of patients maintaining response at two years and no grade 3 adverse events. The company has initiated BLA submission for BCG-unresponsive CIS indication, expecting completion in 2026 and planning a commercial launch with 75-80 staff.
1. BOND-003 Trial Results
CG Oncology reported a 75.5% complete response rate in the BOND-003 Cohort P (papillary disease) with no grade 3 adverse events. From 12 to 24 months roughly 90% of patients who were in complete response at one year remained in response at two years.
2. BLA Submission Timeline
The company has initiated its BLA submission for the BCG-unresponsive CIS cohort, targeting completion in 2026. Remaining CMC work focuses on facility validation, fill-finish processes and module submissions aligned with FDA flexibility on cell and gene therapy manufacturing.
3. Commercial Launch Preparations
CG Oncology has been in pre-launch mode over 15 months, preparing a commercial organization of 75-80 staff. Medical science liaisons are engaging key accounts, a national accounts team is working with payers, and about 300 urology practices could cover over 70% of the targeted market.