CG Oncology initiates rolling BLA for cretostimogene in HR BCG-unresponsive NMIBC

Source excerpt

EX-99.1 2 ck0001991792-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 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 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 Guidelines • Well-positioned to deliver on key milestones with $680.3 million c ash and cash equivalents and marketable securities sufficient to fund operations into the first half of 2028 IRVINE, Calif., November 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 ind

SEC 8-K

More on this asset

Decision-grade

Jul 27, 2026

10:45 PM

CGONCG Oncology

CG Oncology: BOND-003 Phase 3 topline published in The Lancet Oncology

Topline resultsCompany press releaseOpen record