Earnings summaries and quarterly performance for CG Oncology.
Executive leadership at CG Oncology.
Arthur Kuan
Detailed
Chief Executive Officer
CEO
AB
Ambaw Bellete
Detailed
President and Chief Operating Officer
JD
Jim DeTore
Detailed
Interim Principal Financial and Accounting Officer
JP
Joshua Patterson
Detailed
General Counsel, Chief Compliance Officer and Secretary
VK
Vijay Kasturi
Detailed
Chief Medical Officer
Board of directors at CG Oncology.
Research analysts covering CG Oncology.
Recent press releases and 8-K filings for CGON.
CG Oncology Provides Updates on Bladder Cancer Pipeline and Commercial Strategy
CGON
New Projects/Investments
Guidance Update
Product Launch
- CG Oncology is advancing cretostimogene grenadenorepvec (Creto) for bladder cancer, with a BLA submission underway for the BCG-unresponsive indication and a BLA for the intermediate-risk population targeted for 2027.
- Key data readouts are anticipated in the first half of 2026 for the PIVOT-006 trial (intermediate-risk) and CORE-008, Cohort CX (BCG-exposed), with PIVOT-006 enrollment completed nine months ahead of schedule.
- Clinical data for Creto shows a 75.5% complete response rate in BCG-unresponsive patients, with 42% sustained at 24 months, and a strong safety profile with no significant Grade 3 side effects.
- The company maintains a strong financial position with $680 million in cash as of Q3, providing a runway into the first half of 2028 without revenue projections.
- Current manufacturing capacity of 50,000 vials per year is sufficient for the initial launch, with plans to scale up 10 times for the larger intermediate-risk market.
12 hours ago
CG Oncology Provides Updates on Bladder Cancer Programs and BLA Submissions
CGON
Product Launch
Guidance Update
New Projects/Investments
- CG Oncology is focused on developing cretostimogene grenadenorepvec (Credo), an oncolytic immunotherapy for bladder cancer, with a BLA submission for the BCG-unresponsive NMIBC indication set to be completed in 2026.
- In a pivotal trial for BCG-unresponsive NMIBC, Credo demonstrated a 75.5% complete response rate in over 110 patients, with a 42% observed CR rate at 24 months and a 96.4% progression-free rate from muscle-invasive bladder cancer.
- The PIVOT-006 trial for intermediate-risk NMIBC, which enrolled nine months ahead of schedule, is expected to report top-line data in the first half of 2026, with a BLA submission for this indication guided for 2027.
- The company reported a cash balance of $680 million as of Q3 2025, providing a runway into the first half of 2028 without including revenue projections, and plans to launch independently.
- Current manufacturing capacity for Credo is up to 50,000 vials a year, with plans to scale up 10 times to meet future demand.
12 hours ago
CG Oncology Provides Updates on Bladder Cancer Programs and Commercial Strategy
CGON
New Projects/Investments
Product Launch
Guidance Update
- CG Oncology is focused on developing cretostimogene grenadenorepvec (Credo), a bladder-sparing therapeutic for non-muscle invasive bladder cancer (NMIBC), targeting an initial addressable market of 25,000 patients in the BCG-unresponsive segment, with potential expansion to an additional 50,000 patients in the intermediate-risk category.
- The company is currently in the BLA process for its first BCG-unresponsive indication. Key upcoming data readouts include top-line data for the PIVOT-006 intermediate-risk trial and first results for CORE-008, Cohort CX (BCG-exposed) in the first half of 2026. A BLA submission for the intermediate-risk population is guided for 2027.
- Credo has shown best-in-disease efficacy and safety, with a 75.5% complete response rate in BCG-unresponsive patients and a 42% CR at 24 months, demonstrating a strong duration of response and no significant Grade 3 side effects.
- CG Oncology reported a cash balance of $680 million as of Q3 (implied Q3 2025), providing a runway into the first half of 2028 without including revenue projections. The company has current manufacturing capacity for up to 50,000 vials per year and plans to scale up 10 times.
12 hours ago
CG Oncology, Inc. Increases At-The-Market Offering to $550 Million
CGON
- CG Oncology, Inc. filed an Amendment to its Prospectus on January 13, 2026, to increase the aggregate offering price of its common stock available for sale.
- The total aggregate offering price for shares available under the Open Market Sale Agreement with Jefferies LLC has been raised to $550,000,000.
- This increase of $300,000,000 follows the prior sale of $250,000,000 worth of shares under the same agreement.
- The shares offered, when sold and issued, will be validly issued, fully paid, and nonassessable.
2 days ago
CG Oncology Expedites PIVOT-006 Phase 3 Topline Data Timeline
CGON
New Projects/Investments
Guidance Update
- CG Oncology, Inc. announced an expedited timeline for the topline data readout of its PIVOT-006 Phase 3 clinical trial.
- The data for cretostimogene monotherapy in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) is now expected in the first half of 2026, nearly one year ahead of its original schedule.
- This trial is notable as it is the first Phase 3 randomized study in this patient population, for which there are currently no U.S. FDA approved options.
- The intermediate-risk NMIBC patient population in the U.S. is estimated to be greater than 50,000 patients.
7 days ago
CG Oncology Reports Q3 2025 Financial Results and Initiates BLA Submission
CGON
Earnings
Guidance Update
Product Launch
- CG Oncology reported a net loss of $43.8 million, or ($0.57) per share, for the third quarter ended September 30, 2025.
- As of September 30, 2025, the company held $680.3 million in cash, cash equivalents, and marketable securities, which is projected to fund operations into the first half of 2028.
- The company initiated a rolling Biologics License Application (BLA) submission for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC, with complete submission expected in 2026, and completed enrollment for the PIVOT-006 Phase 3 clinical trial.
Nov 14, 2025, 1:15 PM
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