CG Oncology Accelerates PIVOT-006 Phase 3 Data Readout to 1H 2026 and Reports Positive Cretostimogene Results

CG Oncology, Inc.

PIVOT-006 topline data for cretostimogene in intermediate-risk NMIBC now expected in first half of 2026, nearly one year ahead of schedule.
BOND-003 Cohort P showed 95.7% HG-EFS at 3 months, 84.6% at 6 months, and 80.4% at 9 months; no Grade 3+ TRAEs or deaths.
CORE-008 Cohort A (BCG-naïve high-risk NMIBC with CIS) achieved 83.7% overall CR rate (79.2% original, 88.0% optimized administration).
No patients in BOND-003 or CORE-008 progressed to MIBC or underwent radical cystectomy; safety profile favorable.
IR NMIBC population in the US estimated over 50,000 patients; no FDA-approved therapies currently exist for adjuvant setting.

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