CG Oncology, Inc. Stock Price, News & Analysis

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.

CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company specializing in bladder cancer therapeutics, announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference. Chairman & CEO Arthur Kuan will engage in a fireside chat at the conference in Miami Beach on June 10, 2025, at 11:20 am ET. The presentation will be accessible via live audio webcast through the company's Investor Relations website, with replay available for approximately 90 days post-event. CG Oncology focuses on developing bladder-sparing therapeutic solutions for bladder cancer patients.

CG Oncology (NASDAQ: CGON), a late-stage clinical biopharmaceutical company specializing in bladder cancer therapeutics, has announced its participation in the 2025 RBC Capital Markets Global Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, May 20, 2025, at 11:30 am ET in New York. Investors and interested parties can access the live audio webcast through CG Oncology's website investor relations section, with the replay remaining available for approximately 90 days after the presentation.

The company focuses on developing and commercializing a potential backbone bladder-sparing therapeutic for bladder cancer patients.

CG Oncology (NASDAQ: CGON) reported its Q1 2025 financial results and clinical progress. The company presented promising BOND-003 trial results showing 42.3% complete response rate at 24 months for Cohort C and 90.5% high-grade recurrence-free survival at 3 and 9 months for Cohort P in bladder cancer treatment. The company initiated CORE-008 Cohort CX trial evaluating cretostimogene with gemcitabine. Financially, CGON reported cash position of $688.4M, expected to fund operations into H1 2028. Q1 2025 saw increased expenses with R&D at $27.5M (up from $17.2M) and G&A at $14.8M (up from $5.8M), resulting in a net loss of $34.5M ($0.45 per share). Key upcoming milestones include BLA submission initiation and completion of PIVOT-006 Phase 3 enrollment in H2 2025.

CG Oncology (NASDAQ: CGON) and the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC) have announced the inaugural recipients of their NMIBC Research Fellowship Award. Dr. Saum Ghodoussipour from Rutgers Cancer Institute and Dr. Taylor Goodstein from Emory University were selected for their research projects focusing on intra-tumor heterogeneity and spatial transcriptomic profiling in non-muscle invasive bladder cancer. The fellowship aims to support clinical cancer research investigators dedicated to advancing NMIBC treatment and understanding. The awards were presented at the American Urological Association's 2025 Annual Meeting, with winners expected to present their findings at next year's AUA meeting.

CG Oncology (NASDAQ: CGON) has announced significant results for cretostimogene grenadenorepvec in treating bladder cancer at the 2025 American Urological Association Annual Meeting. The Phase 3 BOND-003 Cohort C study showed impressive durability with a 24-month complete response rate of 42.3% in high-risk non-muscle invasive bladder cancer (NMIBC) patients.

Key findings include:

• 75.5% complete response rate at any time
• 97.3% of patients remained free from progression to muscle invasive disease at 24 months
• 91.6% of responders remained cystectomy-free at 24 months
• Median duration of response of 28 months (ongoing)

Additionally, Cohort P demonstrated 90.5% high-grade recurrence-free survival at 3 and 9 months. The treatment showed excellent safety with no Grade 3 or greater treatment-related adverse events reported.