CG Oncology Stock Rallies Nearly 32% in a Week: Here is Why

Core Insights - CG Oncology (CGON) shares have increased nearly 32% in the past week following the announcement of earlier-than-expected top-line data from the phase III PIVOT-006 study, now anticipated in the first half of 2026 [1][8] - Over the last six months, CGON shares have surged 112.8%, significantly outperforming the industry growth of 22.9% [3] Study Details - The phase III PIVOT-006 study is assessing the efficacy of adjuvant intravesical cretostimogene grenadenorepvec against active surveillance in over 360 adult patients with intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) post-tumor resection [2] - The primary endpoint is recurrence-free survival (RFS), with secondary endpoints including RFS at specific intervals and progression-free survival [2] Regulatory and Development Updates - CG Oncology has reported positive durability and response data from the phase III BOND-003 study for high-risk NMIBC patients unresponsive to Bacillus Calmette Guerin, with the FDA granting Fast Track and Breakthrough Therapy designations in December 2023 [6] - A rolling biologics license application submission is underway, expected to be completed in 2026 [6] - A separate phase II CORE-008 study is also evaluating the safety and effectiveness of cretostimogene in high-risk NMIBC [7] Market Context - With no FDA-approved therapies available for IR NMIBC patients post-surgery, the accelerated timeline for the phase III study and positive late-stage data have bolstered expectations for regulatory approval, enhancing investor confidence [9]