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IRVINE, Calif. - CG Oncology, Inc. (NASDAQ:CGON), a clinical-stage biotechnology company with a market capitalization of $2.19 billion, announced updated data from its Phase 3 BOND-003 Cohort C trial showing a 41.8% complete response rate at 24 months for cretostimogene monotherapy in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG treatment. The company’s stock has shown strong momentum, gaining over 15% in the past week, according to InvestingPro data.
The data, which will be presented at the New England Section of the American Urological Association’s annual meeting in Boston, demonstrated that 46 out of 110 patients maintained a complete response at the 24-month mark. Notably, 90% of patients who responded at 12 months remained disease-free at 24 months. Analysts maintain a bullish stance on CGON, with price targets ranging from $40 to $82, reflecting confidence in the company’s clinical progress. For deeper insights into CGON’s valuation and growth potential, InvestingPro subscribers can access comprehensive research reports and additional analyst recommendations.
The study also reported that 96.6% of patients were free from progression to muscle invasive disease at 24 months, with an estimated duration of response rate of 58.3% at 24 months. The median duration of response is 28 months and ongoing.
Safety data remained consistent with previous reports, with no grade 3 or greater treatment-related adverse events or deaths reported. The most common treatment-related adverse events included bladder spasm, pollakiuria, micturition urgency, dysuria, and hematuria.
"The latest data from the BOND-003 Cohort C study demonstrates that if a patient is a responder at 12 months, there is a 90 percent chance they will remain in response at 24 months," said Trinity J. Bivalacqua, MD, PhD, from Penn Medicine, according to the press release.
The company plans to initiate its Biologics License Application submission for cretostimogene in the fourth quarter of 2025. InvestingPro analysis shows CGON maintains a strong financial position with more cash than debt and a healthy current ratio of 22.15, providing adequate resources for its regulatory submission process. The company’s overall financial health score is rated as "FAIR" by InvestingPro’s comprehensive evaluation system.
The trial included 110 heavily pretreated patients who had received a median of 12 prior BCG doses, with some receiving up to 66 doses. Patient adherence was high, with 97.3% completing all expected treatments and no treatment-related discontinuations.
Cretostimogene is an investigational intravesically delivered oncolytic immunotherapy that has not yet received FDA approval.
In other recent news, CG Oncology has completed enrollment in its Phase 3 PIVOT-006 clinical trial for cretostimogene grenadenorepvec, a treatment for intermediate-risk non-muscle invasive bladder cancer. The study enrolled over 360 patients across more than 90 sites, finishing nearly a year ahead of schedule. Piper Sandler has initiated coverage on CG Oncology with an Overweight rating, setting a price target of $55.00. Meanwhile, RBC Capital has lowered its price target to $53.00 but maintained an Outperform rating, citing confidence in the company’s cancer treatment ahead of upcoming updates. Goldman Sachs resumed coverage with a Buy rating and a price target of $40.00, highlighting the competitive clinical profile of CG Oncology’s treatment. Additionally, Morgan Stanley raised its price target from $52.00 to $56.00, maintaining an Overweight rating and noting the anticipated launch of CG Oncology’s treatment in the second half of 2026. These developments reflect ongoing interest and varied expectations from analysts regarding CG Oncology’s progress in the cancer treatment space.
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