The strong Phase 2 data enhance the probability of success for cretostimogene in high-risk NMIBC, but the stock already reflects significant optimism (95% analyst buy). Watch for durability data later this year and next catalysts from Phase 3 trials (BOND-003, PIVOT-006).
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Executive Summary
CG Oncology announced positive Phase 2 data for cretostimogene + gemcitabine in high-risk NMIBC, showing 89.5% HG-EFS at 6 months and 85.7% CR in CIS patients, with no grade 3+ TRAEs. The data support a potential intravesical combination regimen but remain early and require durability follow-up.
Key Facts
- HG-EFS of 96.0% at 3 months and 89.5% at 6 months in ITT population (median follow-up 6.6 months)
- CR rate of 85.7% in CIS-containing ITT population (95% CI 67.3%-96.0%) and 92.3% in efficacy-evaluable population (95% CI 74.9%-99.1%)
- No grade 3 or greater treatment-related adverse events reported; favorable safety profile
- Data to be presented at AUA 2026; durability data expected later in 2026
Financial Impact
Positive read-through for cretostimogene's commercial potential in NMIBC; no revenue impact yet as product remains investigational
Risk Factors
- Early data with small sample size (28 CIS patients); durability results could disappoint
- Phase 3 trials (BOND-003, PIVOT-006) still ongoing and may not replicate these results
- Competitive landscape includes other intravesical therapies (e.g., retifanlimab, targeted agents)
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295777 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 6, 2026 8w ago | Press Release | $74.85 $74.33 | ▲ +0.69% | ▲ +1.29% | $67.38 (+9.98%) |
Aug 6, 2026 8w ago | 424B5 | $74.85 $74.33 | ▲ +0.69% | ▲ +1.29% | $67.38 (+9.98%) |
Jul 27, 2026 9w ago | Press Release | $72.62 $78.95 | ▲ +8.72% | ▲ +5.34% | $67.38 (−7.22%) |
Jul 17, 2026 11w ago | Insider Cluster | $71.85 $75.03 | ▲ +4.43% | ▼ −0.02% | $67.38 (−6.22%) |
Jul 16, 2026 11w ago | Court Ruling | $69.50 $74.71 | ▲ +7.50% | ▲ +3.88% | $67.38 (−3.05%) |
Jun 24, 2026 14w ago | 144 | $72.84 $71.12 | ▼ −2.36% | ▼ −2.89% | $67.38 (−7.50%) |
Jun 22, 2026 14w ago | 144 | $65.73 $70.19 | ▲ +6.79% | ▲ +5.63% | $67.38 (+2.51%) |
Jun 12, 2026 16w ago | Institutional Cluster | $59.56 $75.24 | ▲ +26.33% | ▲ +24.55% | $67.38 (+13.13%) |
May 26, 2026 18w ago | 8-K | $61.89 $70.25 | ▲ +13.50% | ▲ +15.45% | $67.38 (+8.87%) |
May 15, 2026 20w ago | Press Release | $66.93 $59.56 | ▼ −11.01% | ▼ −13.13% | $67.38 (+0.67%) |
US Market Status
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