CG Oncology, Inc. CGON
CG Oncology, Inc. (Nasdaq: CGON) is an oncology drug developer. Its lead program, cretostimogene grenadenorepvec, is in Phase 3 for BCG-unresponsive high-risk NMIBC with CIS.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| cretostimogene | BCG-unresponsive NMIBC (BOND-003 Cohort C) | gene therapy | Phase 3 |
| cretostimogene | intermediate-risk NMIBC (PIVOT-006) | gene therapy | Phase 3 |
Recent results and decisions
- Feb 27, 2026positive BOND-003 Cohort P HG-EFS of 95.7%, 84.6% and 80.4% at 3, 6 and 9 months (SUO late-breaker, Dec 2025 re-presentation).
Cretostimogene demonstrated HG-EFS at 3- 6- and 9-months of 95.7%, 84.6% and 80.4%, respectively, in HR BCG UR Ta/T1 disease in BOND-003 Cohort P.
Filing - Jan 9, 2026positive Investor deck restates SUO 2025 Cohort P data: high-grade event-free survival 95.7% at 3 months, 84.6% at 6 months, 80.4% at 9 months.
BOND-003 Cohort P (HR BCG UR Ta/T1 Disease)2 95.7% (3-mo) HG-EFS 84.6% (6-mo) 80.4% (9-mo)
Filing - Nov 14, 2025submitted Rolling BLA submission to FDA initiated for cretostimogene monotherapy in HR BCG-unresponsive NMIBC; complete submission expected in 2026.
The Company initiated its rolling BLA submission for cretostimogene with complete submission expected in 2026.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.