CG Oncology Advances Bladder Cancer Therapy, Initiates FDA Submission
Company completes Phase 3 trial enrollment 10 months early and reports strong cash position, signaling a clear path to potential commercialization.
CG Oncology (NASDAQ: CGON) has initiated a rolling Biologics License Application (BLA) to the U.S. Food and Drug Administration for its lead immunotherapy candidate, cretostimogene, marking a critical step toward commercializing a new treatment for high-risk non-muscle invasive bladder cancer (NMIBC).
The Irvine, California-based company announced the regulatory milestone in its third-quarter financial report on Thursday, signaling growing confidence in its oncolytic virus therapy. This BLA submission for patients unresponsive to the standard Bacillus Calmette-Guérin (BCG) treatment is a pivotal development for the company, which aims to address a significant unmet need in bladder cancer care. The full submission is expected to be completed in 2026.
Adding to the positive momentum, CG Oncology also revealed it had completed patient enrollment for its Phase 3 PIVOT-006 clinical trial nearly 10 months ahead of schedule. This trial is evaluating cretostimogene in patients with intermediate-risk NMIBC. The rapid enrollment underscores strong interest from clinicians and patients, potentially accelerating the timeline for bringing the therapy to a broader market.
"Initiating our rolling BLA submission is a landmark achievement for CG Oncology, bringing us one step closer to providing a potential new monotherapy option for patients with BCG-unresponsive NMIBC," said Arthur Kuan, President and CEO of CG Oncology, in a statement. "We are also highly encouraged by the rapid enrollment in our PIVOT-006 study, which we believe reflects the enthusiasm of the clinical community for cretostimogene."
Despite the significant operational progress, the company posted a net loss of $43.8 million, or $0.57 per share, for the quarter ending September 30, 2025. This was wider than the $20.4 million loss reported in the same period last year but was in line with analyst expectations. The increased loss was driven by higher research and development expenses, which grew to $27.9 million, and a rise in general and administrative costs.
However, the company's financial footing remains solid. CG Oncology ended the quarter with $680.3 million in cash, cash equivalents, and marketable securities. This substantial cash reserve is projected to fund the company's operations into the first half of 2028, providing a clear financial runway to navigate the final stages of regulatory review and prepare for a potential product launch without immediate financing pressures.
Data from the company's BOND-003 study continues to support the therapy's potential. The trial showed a 75.5% complete response rate in one cohort, with 90% of those responses proving durable at 24 months, demonstrating both efficacy and long-term tolerability.
With a market capitalization of over $3 billion, CG Oncology has seen its stock gain approximately 31.7% year-to-date, significantly outperforming the broader S&P 500. The clinical advancements have bolstered investor confidence, even amid some recent market volatility. The consensus among Wall Street analysts remains a "Strong Buy," with an average price target of $71.70, suggesting a considerable upside from its current trading levels, according to data from TipRanks.
The primary focus for investors and the medical community will now be on the progress of the BLA review process and upcoming data readouts from its clinical programs. The early completion of the PIVOT-006 trial enrollment could lead to an earlier-than-expected data analysis, providing further validation of cretostimogene's profile across different stages of bladder cancer. CG Oncology's strategic execution on both the clinical and regulatory fronts has positioned it as a key player in the development of novel cancer immunotherapies.