Welcome to our dedicated page for CG Oncology news (Ticker: CGON), a resource for investors and traders seeking the latest updates and insights on CG Oncology stock.
CG Oncology, Inc. (NASDAQ: CGON) is a late-stage clinical biopharmaceutical company whose news flow centers on the development of cretostimogene grenadenorepvec, an intravesically delivered oncolytic immunotherapy for non-muscle invasive bladder cancer (NMIBC). Company updates frequently highlight progress in its Phase 3 and Phase 2 clinical programs across high-risk BCG-unresponsive, high-risk BCG-naïve, BCG-exposed, and intermediate-risk NMIBC populations.
Investors and healthcare professionals following CGON news can expect regular announcements on clinical trial milestones, such as completion of enrollment in the PIVOT-006 Phase 3 study in intermediate-risk NMIBC, updated efficacy and safety data from the BOND-003 registrational trial in high-risk BCG-unresponsive disease, and emerging results from the CORE-008 Phase 2 trial. The company also issues releases on regulatory developments, including initiation of a rolling Biologics License Application submission to the U.S. FDA for cretostimogene in high-risk BCG-unresponsive NMIBC with carcinoma in situ with or without Ta/T1 disease.
CG Oncology’s news stream additionally covers scientific presentations and collaborations, such as late-breaking abstracts and posters at the Society of Urologic Oncology Annual Meeting, participation in major healthcare investor conferences, and support of the CG-SUO-CTC NMIBC Research Fellowship aimed at advancing clinical research in bladder cancer. Corporate governance and leadership changes, including board appointments and transitions in financial leadership, are disclosed through both press releases and Form 8-K filings.
This CGON news page aggregates these updates so readers can track key developments in cretostimogene’s clinical performance, regulatory interactions, research partnerships, and corporate events over time.
CG Oncology (NASDAQ: CGON) announced that topline Phase 3 data from the PIVOT-006 study in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) is now expected in 1H 2026, roughly one year earlier than previously planned due to expedited enrollment. The randomized, open-label registrational trial compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance after tumor removal in >360 patients across 90+ sites. PIVOT-006 is described as the first Phase 3 randomized trial in this IR NMIBC population and includes the broadest range of patient types per AUA/SUO guidelines.
CG Oncology (NASDAQ: CGON) said its CEO Arthur Kuan and President & COO Ambaw Bellete will present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026 at 8:15 am PT / 11:15 am ET at the Westin St. Francis in San Francisco.
Investors can listen via a live audio webcast accessible from the company's Investor Relations website at www.cgoncology.com. A replay will be posted shortly after the presentation and archived for about 90 days.
CG Oncology (NASDAQ: CGON) and the Society of Urologic Oncology Clinical Trials Consortium announced the second annual CG‑SUO‑CTC NMIBC Research Fellowship on December 18, 2025. Two investigators will each receive a $50,000 grant to support clinical, translational, or basic research in Non‑Muscle Invasive Bladder Cancer (NMIBC). Applications are due February 27, 2026, 5:00 PM ET. Awarded projects must be presented at the SUO meeting during the American Urological Association annual meeting. Selection is based on research plan quality and available resources.
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.
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