cretostimogene - (PIVOT-006) (EAP)

November 6, 2026: CG Oncology (NASDAQ: CGON) highlighted upcoming 2026 catalysts for cretostimogene grenadenorepvec in non-muscle invasive bladder cancer (NMIBC). For PIVOT-006, a Phase 3 registrational trial in intermediate-risk and high-grade Ta ≤3 cm NMIBC, topline data are anticipated in November 2026. For CORE-008 Cohort CX in BCG-exposed high-risk and BCG-unresponsive NMIBC, and BOND-003 Cohort P in BCG-unresponsive papillary-only NMIBC, 12-month data are expected in December 2026. The company also expects to complete a BLA submission in Q4 2026 for an initial indication in BCG-unresponsive NMIBC with CIS with or without papillary disease.

The release says cretostimogene has been studied in more than 700 NMIBC patients and has FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC. CG Oncology also noted an Expanded Access Program in North America for certain BCG-unresponsive patients.

Financially, cash, cash equivalents, and marketable securities were $984.5 million as of September 30, 2026, which the company says is sufficient to fund operations through 2029. Q3 2026 net loss was $56.9 million, with R&D expense of $39.2 million and G&A expense of $23.0 million.