CG Oncology(US:CGON) Globenewswire·2026-01-09 13:30Core Insights - CG Oncology has announced that topline data from the Phase 3 PIVOT-006 clinical trial is now expected in the first half of 2026, nearly one year ahead of schedule due to rapid enrollment [1][2][3] - The PIVOT-006 trial is the first randomized registrational study evaluating an investigational therapy for intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) [1][3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies for bladder cancer, aiming to improve the quality of life for patients [5] - The company is developing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy, which has been studied in over 400 patients with non-muscle invasive bladder cancer [4] Clinical Trial Details - The PIVOT-006 study involves more than 360 patients and compares adjuvant intravesical cretostimogene grenadenorepvec against surveillance following bladder tumor removal [3] - The trial encompasses a broad range of patient types according to AUA/SUO Guidelines, including high-grade Ta solitary lesions less than 3 cm [1][3] Market Potential - The IR NMIBC patient population in the U.S. is estimated to exceed 50,000, indicating a significant unmet medical need [2][4] - The rapid enrollment across over 90 sites highlights the real-world relevance of the trial and the demand for effective treatment options in this patient demographic [2][3]