CG Oncology, Inc. Stock Price, News & Analysis

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.

CG Oncology (NASDAQ: CGON) has announced a conference call and webcast scheduled for April 28, 2025, at 8:00 am ET to discuss the results of their Phase 3 BOND-003 trial. The trial focuses on cretostimogene monotherapy for high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The results will be initially presented at a Plenary Session at the American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada on April 26, 2025. Interested parties can access the webcast through the company's Investor Relations website at https://ir.cgoncology.com, with an archive available after the call.

CG Oncology (NASDAQ: CGON) announced its participation in the 120th American Urological Association (AUA) Annual Meeting, scheduled for April 26-29, 2025, in Las Vegas. The company will present significant updates on their bladder cancer therapeutic cretostimogene grenadenorepvec.

The highlight will be the presentation of BOND-003 study durability results as a late-breaking announcement during the Practice-changing, Paradigm-shifting Clinical Trials in Urology (P2s) session. This study focuses on cretostimogene monotherapy in high-risk BCG-unresponsive non-muscle invasive bladder cancer.

The company will showcase multiple presentations including:

• Translational correlates using urinary genomic disease burden analysis
• Updates to the CORE-008 trial protocol
• Progress updates on BOND-003 Cohort P study
• Details on the Phase 3 PIVOT-006 randomized study

CG Oncology (NASDAQ: CGON) reported significant progress in their bladder cancer therapeutic development for 2024. Their lead candidate cretostimogene demonstrated a 75.5% complete response rate in high-risk BCG-unresponsive non-muscle invasive bladder cancer patients, with response duration exceeding 28 months.

Key developments include:

• Successful completion of a $238 million follow-on public offering, extending runway into H1 2028
• Initiation of CORE-008 clinical trial for BCG-naïve and BCG-exposed NMIBC patients
• Publication of Phase 1b study results in Nature Medicine

Financial results show cash position of $742.0 million as of December 31, 2024. R&D expenses increased to $82.1 million for 2024 (vs $45.8M in 2023), while G&A expenses rose to $33.7 million (vs $9.9M in 2023). Net loss for 2024 was $88.0 million ($1.41 per share).