CGON Stock Rallies 27% in a Month on Bladder Cancer Study Success

CG Oncology CGON 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.

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, 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 Anktiva and Merck’s MRK 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.

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This article originally published on Zacks Investment Research (zacks.com).

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