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CG Oncology, Inc. (CGON) delivers timely updates on its pioneering work in bladder cancer immunotherapy. This page consolidates official announcements, clinical trial progress, and strategic developments for stakeholders tracking advancements in non-muscle invasive bladder cancer (NMIBC) treatments.
Access verified information on phase three trial milestones, regulatory interactions, and research partnerships shaping the future of oncolytic therapies. Investors and medical professionals will discover structured updates on cretostimogene grenadenorepvec's development, including combination therapies with checkpoint inhibitors.
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Bookmark this page for streamlined access to CGON's latest developments in bladder-sparing immunotherapies. Regularly updated to reflect the company’s progress through critical clinical and regulatory stages.
CG Oncology (NASDAQ: CGON) has published final results from its Phase 2 CORE-001 trial of cretostimogene and pembrolizumab in BCG-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) in Nature Medicine and presented them at ASCO 2024.
The trial met its primary endpoint with a 54% complete response (CR) rate at 24 months in the intention-to-treat (ITT) population. The 12-month CR was 57%, with 95% of these patients maintaining CR for an additional 12 months.
Progression-free survival (PFS) at 24 months was 100%, with no patients advancing to muscle invasive or metastatic disease. Cystectomy-free survival (CFS) at 24 months was 80%, and 100% for patients in CR. Treatment-related adverse events were consistent with those of the individual agents.
The combination received FDA Breakthrough Therapy Designation in May 2023, and cretostimogene monotherapy also received Fast Track and Breakthrough Therapy Designations in December 2023. Topline data from the Phase 3 BOND-003 trial is expected by the end of 2024.
CG Oncology (NASDAQ: CGON) has announced final results from its Phase 2 CORE-001 trial of cretostimogene in combination with pembrolizumab for treating BCG-Unresponsive High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC). The trial achieved a 54% complete response (CR) rate at 24 months, meeting its primary endpoint. The data will be presented at the ASCO 2024 Annual Meeting. Results show significant efficacy with 83% CR rate at any time and 77.3% at 12 months. Moreover, 95% of patients in CR at 12 months remained in CR for another 12 months. Progression-free survival at 24 months is 100%, with no progression to muscle-invasive or metastatic disease. The Kaplan-Meier estimates for CR rate at 24 months are 69.6%. Treatment-related adverse events were consistent with individual agents. The combination therapy has received FDA Breakthrough Therapy Designation, and CG Oncology plans to incorporate these findings into a future CORE-008 trial.
CG Oncology reported their financial results for the first quarter of 2024, showcasing a 75.2% Complete Response Rate for their Cretostimogene Monotherapy in patients with High-Risk Non-Muscle Invasive Bladder Cancer. The company also dosed the first patient in a Phase 3 trial and presented final results from a Phase 2 trial of Cretostimogene in combination with Pembrolizumab. In addition, they completed an oversubscribed $437 million IPO and expect their cash runway to last until 2027.
CG Oncology, Inc. announced positive Phase 3 BOND-003 study results for cretostimogene monotherapy in treating high-risk, BCG-unresponsive Non-Muscle Invasive Bladder Cancer. The study showed a 75.2% complete response rate with durable responses over 12 months. No Grade 3 or higher treatment-related adverse events were reported. Cretostimogene has the potential to be a preferred therapy over surgical options in this patient population.
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