GlobeNewswire·Jan 9, 2026, 8:30 AM ET

CG Oncology Provides Updated Timeline for PIVOT-006 Phase 3 Topline Data in Intermediate-Risk NMIBC

CG Oncology expects topline data from the Phase 3 PIVOT-006 trial in the first half of 2026, nearly one year ahead of schedule.
The PIVOT-006 trial is the first randomized Phase 3 study to evaluate an investigational therapy in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC).
The trial compares adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in over 360 patients across more than 90 sites.
Study enrollment included the broadest range of patient types per AUA/SUO Guidelines, such as HG Ta solitary lesions under 3cm.
Cretostimogene is an investigational oncolytic immunotherapy with no current U.S. FDA approved options for the adjuvant IR NMIBC indication.
The company's clinical development program includes over 400 patients, two Phase 3 trials (BOND-003 & PIVOT-006), a Phase 2 trial (CORE-008), & an Expanded Access Program.
The IR NMIBC patient population in the U.S. is estimated to exceed 50,000 individuals.
CG Oncology warns that actual results may differ from forward-looking statements due to risks including data changes, enrollment delays, capital constraints, & regulatory uncertainties.