CGON News & Events

Wolfe Research notes that CG Oncology announced the departure of the company's COO Ambaw Bellete this morning. The departure sounds more operational in nature and is not indicative of any disruption to ongoing programs, the firm says. adding that the company noted that the change has no impact on CMC, BLA filing timing, or the PIVOT-006 trial. Wolfe also learned that the CCO was not involved in PIVOT-006, which remains blinded and is under Vijay's team. Shares are weak following the news, though the firm views this as a temporary blip and would expect focus to return to the upcoming readout, which it believes is likely to be positive. Wolfe has a Peer Perform rating on the stock.

In a regulatory filing, CG Oncology announced that on May 20, the company and Ambaw Bellete, the company's President & COO, agreed to his separation from the company to be effective June 30. The company thanks Bellete for his contributions and wishes him well in his next endeavors. The company has initiated a search for a Chief Commercial Officer. On May 20, the company's Board of Directors also approved the appointment of Arthur Kuan as President of the company, in addition to his other positions, in connection with Bellete's separation. Shares of CG Oncology are down nearly 4% to $61.69.

CG Oncology announced first results from CORE-008 Cohort CX, a Phase 2 study evaluating intravesical cretostimogene grenadenorepvec in combination with gemcitabine sequential versus concurrent treatment schedules in patients with high-risk non-muscle invasive bladder cancer. This trial includes HR NMIBC patients who are either BCG-exposed or BCG-unresponsive. The data, which demonstrate encouraging high-grade event-free survival, high complete response rates and a well-tolerated safety profile, will be presented tomorrow at the Society of Urologic Oncology Session at the 2026 American Urological Association annual meeting in Washington, D.C. As of the March 13, data cut off, the overall HG-EFS was 96% at 3 months and 89.5% at 6 months, with a median follow-up of 6.6 months, in the overall intent-to-treat population. There were no statistically significant differences in HG-EFS across concurrent and sequential treatment arms. High complete response rates at any time were observed in the CIS-containing population with 85.7% and 92.3% in the ITT population with 85.7% and Efficacy Evaluable population with 92.3%, respectively. Furthermore, complete response rates were maintained across the treatment arms. A favorable safety and tolerability profile was observed with no Grade 3 or greater treatment-related adverse events and no deaths reported. The majority of patients were male, white, and over 65 years of age, with the cohort well-balanced across concurrent and sequential treatment arms. Out of the overall population, 65.6% of patients were BCG-exposed and 34.5% were BCG-unresponsive. More than 80% of patients were treated in community practices.