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CGON Stock Rallies 27% in a Month on Bladder Cancer Study Success
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CG Oncology (CGON - Free Report) shares have rallied 26.5% in a month. This upsurge was observed after the company, in late April, announced superior efficacy data from some cohorts of a late-stage study of its investigational candidate, cretostimogene grenadenorepvec, which is being evaluated as a monotherapy for non-muscle invasive bladder cancer (NMIBC) patients.
Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy, which is being evaluated both as a monotherapy and in combinations across several mid- and late-stage studies for different bladder cancer indications.
CGON’s Phase III Bladder Cancer Study Results in Detail
The eligible patient population for CG Oncology’s phase III BOND-003 Cohort C study of cretostimogene included high-risk NMIBC patients who were unresponsive to Bacillus Calmette-Guérin (BCG) therapy and had carcinoma in situ (CIS), with or without concomitant Ta or T1 disease (papillary tumors).
As of the cut-off date of March 14, 2025, the data from the study showed a complete response (CR) rate of 75.5% at any time point, with 34 confirmed CRs at 24 months and nine patients still awaiting their 24-month assessment. Study results so far show a CR of 46.4% at 12 months and 33.7% at 24 months. The median duration of response was 28 months and continues to be sustained. Importantly, 97.3% of patients remained free from progression to muscle-invasive disease and 91.6% of responders remained cystectomy-free at 24 months.
Year to date, CGON shares have lost 8.6% compared with the industry’s 4.3% decline.
Image Source: Zacks Investment Research
CG Oncology also reported that in Cohort P of the BOND-003 study, which included patients with BCG-unresponsive Ta/T1 bladder cancer without CIS, cretostimogene achieved an estimated high-grade recurrence-free survival rate of 90.5% at both three and nine months among the 24 patients treated.
Despite being highly pre-treated, cretostimogene was well tolerated by the high-risk NMIBC patient population in the phase III BOND-003 Cohort C study. All treatment-related adverse events were mild to moderate. CG Oncology reported that 97.3% of patients completed all planned treatments, indicating strong adherence and compliance.
Based on such encouraging phase III results, management believes that cretostimogene has the potential to become a breakthrough backbone therapy in bladder cancer treatment.
CGON’s Competition in the NMIBC Space
CG Oncology faces significant rivalry from pharma bigwig, Johnson and Johnson (JNJ - Free Report) , in the market for bladder cancer treatments. We remind the investors that in January 2025, J&J initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat the same NMIBC patient population as CGON’s cretostimogene. If approved, TAR-200 will be the first intravesical drug-releasing system in the given indication.
JNJ’s TAR-200 enjoys the FDA’s Breakthrough Therapy designation in the United States for the above NMIBC indication.
ImmunityBio’s (IBRX - Free Report) Anktiva and Merck’s (MRK - Free Report) Keytruda are both approved to treat high-risk NMIBC in patients unresponsive to the BCG vaccine. However, the Merck and ImmunityBio drugs utilize a different mechanism of action compared to JNJ’s TAR-200 and CGON’s cretostimogene — IBRX’s Anktiva is an IL-15 antibody drug, approved for intravesical use in combination with the BCG vaccine. MRK’s Keytruda is a blockbuster PD-1 inhibitor approved for use as a single agent. However, it is administered intravenously.
Although primarily used to prevent tuberculosis, the BCG vaccine is also a standard treatment for some forms of bladder cancer.
Image: Bigstock
CGON Stock Rallies 27% in a Month on Bladder Cancer Study Success
CG Oncology (CGON - Free Report) shares have rallied 26.5% in a month. This upsurge was observed after the company, in late April, announced superior efficacy data from some cohorts of a late-stage study of its investigational candidate, cretostimogene grenadenorepvec, which is being evaluated as a monotherapy for non-muscle invasive bladder cancer (NMIBC) patients.
Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy, which is being evaluated both as a monotherapy and in combinations across several mid- and late-stage studies for different bladder cancer indications.
CGON’s Phase III Bladder Cancer Study Results in Detail
The eligible patient population for CG Oncology’s phase III BOND-003 Cohort C study of cretostimogene included high-risk NMIBC patients who were unresponsive to Bacillus Calmette-Guérin (BCG) therapy and had carcinoma in situ (CIS), with or without concomitant Ta or T1 disease (papillary tumors).
As of the cut-off date of March 14, 2025, the data from the study showed a complete response (CR) rate of 75.5% at any time point, with 34 confirmed CRs at 24 months and nine patients still awaiting their 24-month assessment. Study results so far show a CR of 46.4% at 12 months and 33.7% at 24 months. The median duration of response was 28 months and continues to be sustained. Importantly, 97.3% of patients remained free from progression to muscle-invasive disease and 91.6% of responders remained cystectomy-free at 24 months.
Year to date, CGON shares have lost 8.6% compared with the industry’s 4.3% decline.
Image Source: Zacks Investment Research
CG Oncology also reported that in Cohort P of the BOND-003 study, which included patients with BCG-unresponsive Ta/T1 bladder cancer without CIS, cretostimogene achieved an estimated high-grade recurrence-free survival rate of 90.5% at both three and nine months among the 24 patients treated.
Despite being highly pre-treated, cretostimogene was well tolerated by the high-risk NMIBC patient population in the phase III BOND-003 Cohort C study. All treatment-related adverse events were mild to moderate. CG Oncology reported that 97.3% of patients completed all planned treatments, indicating strong adherence and compliance.
Based on such encouraging phase III results, management believes that cretostimogene has the potential to become a breakthrough backbone therapy in bladder cancer treatment.
CGON’s Competition in the NMIBC Space
CG Oncology faces significant rivalry from pharma bigwig, Johnson and Johnson (JNJ - Free Report) , in the market for bladder cancer treatments. We remind the investors that in January 2025, J&J initiated a rolling submission with the FDA seeking approval for TAR-200, its investigational drug-device combination to treat the same NMIBC patient population as CGON’s cretostimogene. If approved, TAR-200 will be the first intravesical drug-releasing system in the given indication.
JNJ’s TAR-200 enjoys the FDA’s Breakthrough Therapy designation in the United States for the above NMIBC indication.
ImmunityBio’s (IBRX - Free Report) Anktiva and Merck’s (MRK - Free Report) Keytruda are both approved to treat high-risk NMIBC in patients unresponsive to the BCG vaccine. However, the Merck and ImmunityBio drugs utilize a different mechanism of action compared to JNJ’s TAR-200 and CGON’s cretostimogene — IBRX’s Anktiva is an IL-15 antibody drug, approved for intravesical use in combination with the BCG vaccine. MRK’s Keytruda is a blockbuster PD-1 inhibitor approved for use as a single agent. However, it is administered intravenously.
Although primarily used to prevent tuberculosis, the BCG vaccine is also a standard treatment for some forms of bladder cancer.
CG Oncology, Inc. Price and Consensus
CG Oncology, Inc. price-consensus-chart | CG Oncology, Inc. Quote
CGON's Zacks Rank
CG Oncology currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.