CG Oncology, Inc. Stock Price, News & Analysis

CG Oncology (NASDAQ: CGON) reported topline results Dec 5, 2025 from BOND-003 Cohort P and CORE-008 Cohort A showing promising efficacy and tolerability for cretostimogene in non‑muscle invasive bladder cancer (NMIBC).

In BOND-003 Cohort P (BCG‑unresponsive papillary-only), HG‑EFS by Kaplan‑Meier at 3/6/9 months was 95.7%, 84.6% and 80.4% (data cut-off Sep 1, 2025; 51 evaluable patients). CORE-008 Cohort A (high‑risk, BCG‑naïve CIS) showed overall CR 83.7% with optimized administration CR 88.0% (data cut-off Sep 1, 2025; 49 evaluable patients). No Grade ≥3 treatment‑related AEs, no treatment‑related discontinuations, and no progressions to MIBC reported.

CG Oncology (NASDAQ: CGON) appointed Christina Rossi to its Board of Directors and reported the resignation of Simone Song effective November 22, 2025. The company noted it has initiated a BLA for cretostimogene, positioning the firm to prepare for a potential commercial launch upon FDA approval.

Ms. Rossi brings >25 years of global pharma and biotech experience, including roles as Chief Operating Officer and Chief Commercial Officer at Blueprint Medicines and prior commercial leadership at Sanofi Genzyme and Biogen. The company emphasized commercial launch readiness and thanked Ms. Song for over a decade of board service.

CG Oncology (NASDAQ: CGON) will present clinical results for cretostimogene grenadenorepvec at the Society of Urologic Oncology (SUO) 26th Annual Meeting in Phoenix, AZ, December 2–5, 2025.

The company will give two late-breaking podium presentations on BOND-003 Cohort P (BCG-unresponsive, papillary-only) and CORE-008 Cohort A (BCG-naïve with carcinoma in situ) on December 5, 2025, plus three posters including 24-month durable outcomes from BOND-003 Cohort C and trials-in-progress for CORE-008 Cohort B and an expanded access program.

CG Oncology (NASDAQ: CGON) reported Q3 2025 results and business updates on Nov 14, 2025. Key clinical progress includes initiation of a rolling BLA submission for cretostimogene in high-risk BCG-unresponsive NMIBC with CIS, with completion expected in 2026, and a reported 24-month complete response (CR) rate of 41.8% (46/110) from BOND-003 Cohort C. The company completed enrollment of the Phase 3 PIVOT-006 trial ~10 months early and expects multiple topline readouts in 4Q'25–1H'26. Financially, cash and marketable securities were $680.3M as of Sept 30, 2025, projected to fund operations into H1 2028.

CG Oncology (NASDAQ: CGON) has reported impressive updated data from its BOND-003 Cohort C trial for cretostimogene, showing a 41.8% complete response (CR) rate at 24 months in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to BCG treatment.

The study demonstrated remarkable durability with 90% of 12-month responders remaining disease-free at 24 months. Among 110 heavily pretreated patients, 96.6% remained free from progression to muscle invasive disease at 24 months. The treatment showed excellent tolerability with no Grade 3 or greater treatment-related adverse events.

The company plans to initiate its BLA submission for cretostimogene in Q4 2025, positioning it as a potential breakthrough bladder-sparing therapeutic option.

CG Oncology (NASDAQ: CGON) has completed enrollment in its Phase 3 PIVOT-006 clinical trial, evaluating cretostimogene grenadenorepvec versus surveillance in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) patients. The study enrolled over 360 patients across 90+ sites, achieving completion nearly a year ahead of schedule.

The trial aims to address a significant unmet need, as IR NMIBC patients face recurrence rates of up to 70% with limited durable treatment options. Cretostimogene's novel approach works by selectively lysing tumor cells while activating anti-cancer immune responses, potentially offering a new treatment paradigm for bladder cancer patients.

CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company developing bladder-sparing therapeutics for bladder cancer, has announced upcoming presentations at two major investor conferences. The company's leadership team, including Chairman & CEO Arthur Kuan and President & COO Ambaw Bellete, will participate in fireside chats at:

- The Cantor Global Healthcare Conference on September 5, 2025, at 10:20am ET
- The Morgan Stanley 23rd Annual Global Healthcare Conference on September 9, 2025, at 7:45am ET

Both presentations will be accessible via webcast on the company's investor relations website and will remain archived for approximately 90 days.

CG Oncology (NASDAQ: CGON) reported significant progress in Q2 2025, highlighted by impressive clinical results for their bladder cancer therapy cretostimogene grenadenorepvec. The company presented best-in-disease durability data showing a 75.5% complete response rate in the BOND-003 Cohort C trial, with 97.3% of patients free from disease progression at 24 months.

Key developments include initiating the CORE-008 Cohort CX trial combining cretostimogene with gemcitabine, and a favorable legal verdict against ANI Pharmaceuticals eliminating future royalty obligations. The company maintains a strong financial position with $661.1 million in cash, expecting to fund operations into H1 2028. Q2 resulted in a net loss of $41.4 million, with plans to initiate BLA submission in Q4 2025.

CG Oncology (NASDAQ: CGON) has secured a significant legal victory as a Delaware Superior Court jury unanimously ruled in the company's favor regarding a lawsuit filed by ANI Pharmaceuticals in March 2024. The Court determined that CG Oncology will not owe any future royalties on sales of cretostimogene grenadenorepvec, their investigational bladder cancer treatment.

The ruling eliminates a potential 5% royalty obligation on commercial sales and confirms no further payments are due to ANI Pharmaceuticals. This decision follows Judge Sheldon K. Rennie's July 16, 2025 ruling that legally barred ANI Pharmaceuticals from claiming royalties on future cretostimogene sales.