CG Oncology, Inc. - CGON STOCK NEWS

CG Oncology has launched an Expanded Access Program (EAP) for cretostimogene grenadenorepvec in the U.S. for patients with Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The first patient has been dosed, and enrollment is ongoing. This move aims to provide more treatment options for NMIBC patients, reflecting CG Oncology's commitment to addressing this recurrent cancer. Key figures in the bladder cancer community, such as Andrea Maddox-Smith from the Bladder Cancer Advocacy Network, emphasize the hope that EAPs represent for patients who have exhausted all approved treatments.

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.

CG Oncology, Inc. (NASDAQ: CGON) will host a virtual investor event on May 3, 2024, to discuss the results from the Phase 3 BOND-003 trial presented at the 2024 AUA Annual Meeting. The company focuses on developing bladder-sparing therapeutics for bladder cancer patients. The event will feature updates on the progress of its oncolytic immunotherapy cretostimogene. Details of the AUA presentation and webcast replay can be found on the company's investor relations website.

CG Oncology, Inc. (NASDAQ: CGON) to present final results of CORE-001 Phase 2 trial of cretostimogene in combination with pembrolizumab at ASCO 2024. The trial focuses on treating BCG-unresponsive NMIBC, with encouraging data. The abstract will be presented by lead study investigator Roger Li, M.D., at the ASCO Annual Meeting in Chicago, IL, on June 2, 2024.

CG Oncology, Inc. (NASDAQ: CGON) announces the presentation of new 12-month data from the Phase 3 BOND-003 trial at the American Urological Association Annual Meeting. The data highlights cretostimogene, a potential bladder-sparing therapeutic for bladder cancer patients. The company aims to improve outcomes for patients with bladder cancer through these clinical trials.

CG Oncology initiates the PIVOT-006 Phase 3 clinical trial for Non-Muscle Invasive Bladder Cancer patients with cretostimogene. The trial aims to improve recurrence-free survival and progression-free survival, targeting intermediate-risk patients facing limited treatment options.