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 a wider third-quarter net loss as research and development spending increased from the prior-year period. Net loss was $56.9 million, or $0.64 per share, versus $43.8 million, or $0.57 per share. Revenue declined to $1.604 million from $1.666 million. Research and development expenses rose to $39.2 million, while general and administrative expenses fell to $23.0 million.
The company anticipates PIVOT-006 Phase 3 topline data in November 2026, 12-month data from CORE-008 Cohort CX and BOND-003 Cohort P in December, and completion of its initial cretostimogene biologics license application in Q4 2026. The application targets BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary disease. Cash and securities totaled $984.5 million at September 30, down from $1.0 billion at June 30; the company expects funding to last through 2029.
CG Oncology (CGON) appointed Isabel Kalofonos as Chief Commercial Officer to lead the company's commercial strategy and execution ahead of a potential launch.
The company is preparing for a potential first commercial launch of cretostimogene grenadenorepvec, subject to approval. Kalofonos brings more than 20 years of commercial leadership experience. She most recently served as Chief Commercial Officer at Crinetics Pharmaceuticals, where she helped launch PALSONIFY. Previously, she held the same role at ImmunoGen, where she led the launch of ELAHERE in ovarian cancer.
CG Oncology (CGON) will participate in fireside chat presentations at the Cantor Fitzgerald and Morgan Stanley Global Healthcare Conferences in New York City in September 2026.
The Cantor Fitzgerald Global Healthcare Conference presentation is scheduled for Wednesday, September 9, 2026 at 8:00 a.m. ET, and the Morgan Stanley Global Healthcare Conference presentation will take place on Monday, September 14, 2026 at 4:50 p.m. ET. Live audio webcasts and replays will be available via the Investor Relations section of the company’s website for about 90 days.
CG Oncology (NASDAQ: CGON) reported second quarter 2026 results and clinical, regulatory and legal updates. For the quarter ended June 30, 2026, total revenue was $1.2 million, driven by commercial and development revenue, while the company recorded a net loss of $79.1 million or $(0.90) per share.
R&D expenses rose to $54.7 million and G&A to $29.0 million, reflecting higher clinical, CMC and personnel costs. Cash, cash equivalents and marketable securities were about $1.0 billion, which CG Oncology expects will fund operations through 2029. Phase 3 PIVOT-006 topline data in intermediate-risk NMIBC are anticipated near term, and completion of a BLA for high-risk BCG-unresponsive NMIBC is expected in 4Q 2026. Phase 3 BOND-003 Cohort C results were published in The Lancet Oncology, and a Delaware court ruling upheld a prior jury verdict maintaining the company’s agreement with ANI.
CG Oncology (NASDAQ: CGON) reported that pivotal Phase 3 BOND-003 Cohort C results for intravesical cretostimogene grenadenorepvec monotherapy in high-risk, BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ were published in The Lancet Oncology. The single-arm trial met its primary endpoint with statistical significance, with 75.5% of patients achieving a complete response at any time.
According to CG Oncology, 12- and 24-month duration of response rates were 64.2% and 60.1%, with median duration of response at least 27.9 months and ongoing, and one patient disease-free beyond 51 months. Approximately 89% of patients maintained their bladders at 12 months and 81% at 24 months, while 96.6% remained free from progression to muscle-invasive disease at 48 and 96 weeks. No Grade 3 or higher treatment-related adverse events, discontinuations, or deaths were reported, and administration is office-based without need for prophylactic medication, operating room time, or anesthesia.
CG Oncology (NASDAQ: CGON) announced that Chairman, President & CEO Arthur Kuan will participate in fireside chats at two June 2026 healthcare investor conferences.
He will present at the Jefferies Global Healthcare Conference on June 3 in New York and the Goldman Sachs 47th Annual Global Healthcare Conference on June 9 in Miami, with live and archived webcasts available.
CG Oncology (NASDAQ: CGON) and the Society of Urologic Oncology Clinical Trials Consortium announced recipients of the second annual NMIBC Research Fellowship, supporting Non-Muscle Invasive Bladder Cancer research with grants up to $50,000 each.
Grants were awarded to Dr. Patrick Hensley and Dr. Daniel Joyce for projects in AI prognostic biomarkers and price transparency.
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.