CG Oncology Soars 20.97% on Breakthrough Bladder Cancer Trial Results

On April 28, 2025, CG Oncology's stock surged by 20.97% in pre-market trading, driven by significant developments in its clinical trials.

CG Oncology recently announced impressive results from its Phase 3 BOND-003 trial, focusing on the effectiveness of cretostimogene grenadenorepvec in treating bladder cancer. The trial demonstrated a 24-month complete response rate of 42.3% in high-risk non-muscle invasive bladder cancer (NMIBC) patients who were unresponsive to BCG treatment. Additionally, 97.3% of patients remained free from progression to muscle-invasive disease at 24 months, and 91.6% of responders remained cystectomy-free at the same duration. The treatment also showed an excellent safety profile with no Grade 3 or greater treatment-related adverse events reported.

These findings were presented at the 2025 American Urological Association Annual Meeting, highlighting the potential of cretostimogene as a breakthrough therapy for BCG-unresponsive high-risk NMIBC. The data showed that 90.5% of patients in Cohort P, which included those with Ta/T1 disease without CIS, achieved high-grade recurrence-free survival at 3 and 9 months. This broadens the potential utility of cretostimogene beyond CIS-containing disease, positioning it as a potential backbone therapy for multiple NMIBC presentations.

The robust efficacy and safety data from the BOND-003 trial significantly enhance CG Oncology's clinical and commercial profile. The company is preparing to reveal the outcomes of its Phase 3 BOND-003 trial, which is expected to further validate the potential of cretostimogene as a groundbreaking treatment for bladder cancer. The positive results from the trial have materially enhanced CG Oncology's position in the bladder cancer space, supporting its strategic efforts to bring this innovative therapy to patients.