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. reports developments as a late-stage clinical biopharmaceutical company developing cretostimogene grenadenorepvec for bladder cancer. Its updates center on non-muscle invasive bladder cancer, including high-risk BCG-unresponsive, BCG-exposed and intermediate-risk disease settings, and describe clinical studies such as PIVOT-006, BOND-003 and CORE-008.
Recurring company news also covers financial results, FDA-related regulatory planning, clinical data presentations, manufacturing and BLA preparation, investor conference participation and research initiatives tied to NMIBC. The company's disclosures connect its operating cash position and development spending to the advancement of its bladder-sparing immunotherapy program.
CG Oncology (NASDAQ:CGON) reported first Phase 2 results from CORE‑008 Cohort CX, evaluating intravesical cretostimogene grenadenorepvec plus gemcitabine in high‑risk non‑muscle invasive bladder cancer patients who were BCG‑exposed or BCG‑unresponsive.
High‑grade event‑free survival was 96.0% at 3 months and 89.5% at 6 months (median follow‑up 6.6 months). In CIS‑containing patients, complete response rates were 85.7% (24/28) in the ITT population and 92.3% (24/26) in the efficacy‑evaluable population. Efficacy appeared comparable between concurrent and sequential regimens, and no Grade 3 or higher treatment‑related adverse events or deaths were reported.
CG Oncology (NASDAQ: CGON) will participate in the AUA 2026 Annual Meeting in Washington, D.C., on May 15–18, 2026. The company will present first results from its CORE-008 Cohort CX Phase 2 trial in high-risk BCG-exposed and BCG-unresponsive NMIBC.
CG Oncology will also exhibit at booth #3051 and support CG-SUO-CTC NMIBC Research Fellowship presentations highlighting novel research in non-muscle invasive bladder cancer.
CG Oncology (NASDAQ: CGON) reported Q1 2026 results and program updates on May 8, 2026. Key points: $1.1 billion in cash, cash equivalents and marketable securities as of March 31, 2026; net loss $60.2M (Q1 2026); R&D $43.7M and G&A $20.8M for the quarter.
Clinical timelines: PIVOT-006 Phase 3 topline data expected in 1H 2026, CORE-008 Cohort CX Phase 2 first results presented at AUA on May 16, 2026, and BLA completion expected in 4Q 2026.
CG Oncology (NASDAQ: CGON) will present at two investor conferences in May 2026. Arthur Kuan, CEO, and Ambaw Bellete, President & COO, will participate in fireside chats on May 12 at the Bank of America Health Care Conference (10:40–11:10 AM PT, Las Vegas) and May 20 at the RBC Global Healthcare Conference (2:35–3:00 PM ET, New York).
Live audio webcasts will be available via the company's Investor Relations website, with replays archived for approximately 90 days.
CG Oncology (NASDAQ: CGON) reported year-end 2025 results and pipeline timing updates on Feb 27, 2026. The company holds approximately $903.0 million in cash, cash equivalents and marketable securities as of Feb 26, 2026, expected to fund operations into the first half of 2029.
Key clinical milestones include Phase 3 PIVOT-006 topline data and CORE-008 Cohort CX first combination results, both expected 1H 2026. 2025 operating metrics showed higher R&D and G&A spend and a wider net loss versus 2024.
CG Oncology (NASDAQ: CGON) said its CEO Arthur Kuan and President Ambaw Bellete will present at the TD Cowen 46th Annual Health Care Conference on March 2, 2026 at 3:10 PM ET in Boston.
Investors can listen via a live audio webcast on the company website; a replay will be archived for about 90 days after the presentation.
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.