During its January presentation, CG Oncology detailed the progress of two lead programs: CG-806 in acute myeloid leukemia (AML) and PIVOT-006 in diffuse large B-cell lymphoma (DLBCL). The company reported that CG-806 continues to demonstrate a favorable safety profile, with no dose-limiting toxicities observed in the expansion cohort of 18 patients at the 200 mg daily dose. Investigator-assessed responses include two complete remissions and five partial remissions, yielding an overall response rate of 39%. Management reiterated plans to initiate a registration-directed trial in relapsed or refractory AML by mid-2026.

CG Oncology announced that enrollment in its pivotal PIVOT-006 trial of zanidatamab plus standard immunochemotherapy in first-line HER2-positive gastric cancer reached full enrollment across 92 global sites in December, nearly six months ahead of the original timeline. With 620 patients now randomized, the company expects to report top-line overall survival data in the first half of 2026, accelerating its previous guidance by roughly twelve months. Key secondary endpoints include progression-free survival and objective response rate, with interim safety analyses planned upon 50% of events.

Following the enrollment update and conference presentation, CG Oncology’s shares surged by nearly 32% over five trading days, reflecting renewed investor enthusiasm. Trading volume tripled its 30-day average, indicating heightened market interest. Analysts at two major brokerage firms raised their likelihood-of-approval estimates for both CG-806 and zanidatamab, citing the accelerated trial timelines and robust initial safety data. Institutional investors increased their holdings by an estimated 2.5 million shares during the week, suggesting strong conviction in the company’s late-stage development strategy.