Business
CG Oncology Reports Third Quarter 2025 Financial Results and Provides Business Updates
Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle
About this update from Cg Oncology, Inc.
[{"type":"text","content":"Initiated rolling Biologics License Application (BLA) submission to U.S. FDA for cretostimogene monotherapy in high-risk (HR) BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)Demonstrated continued best-in-disease durability and tolerability in BOND-003 Cohort C with robust 24-month complete response (CR) rate of 41.8% observed for cretostimogene monotherapy in patients with HR NMIBC unresponsive to Bacillus Calmette Guerin (BCG)Completed enrollment of PIVOT-006, one of the largest randomized Phase 3 studies in intermediate risk (IR) NMIBC encompassing broadest range of patients per AUA/SUO GuidelinesWell-positioned to deliver on key milestones with $680.3 million cash and cash equivalents and marketable securities sufficient to fund operations into the first half of 2028 IRVINE, Calif., Nov. 14, 2025 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the third quarter ended September 30, 2025, and provided business updates. “I am proud of the meaningful progress we have made over the last few months, most notably, the initiation of our BLA submission of cretostimogene for our lead indication of HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease. With cretostimogene’s unique profile, we remain committed to advancing a robust clinical, regulatory, and technical strategy designed to support an optimized label and expansion into additional indications—positioning cretostimogene as a potential backbone therapy for a broad range of NMIBC patients,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “We look forward to sharing additional data from BOND-003 Cohort P and CORE-008 Cohort A before year-end.” Corporate Highlights Initiated BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC with CIS with or without Ta/T1 disease. The Company initiated its rolling BLA submission for cretostimogene with complete submission expected in 2026. Cretostimogene has both Fast Track and Breakthrough Therapy Designations which are intended to accelerate the path to U.S. FDA submission.Presented Best-in-Disease Durability and Tolerability Data from BOND-003 Cohort C. In Septembe...