CG Oncology sees PIVOT-006 topline data in November, BLA completion in Q4

CG Oncology reported third quarter 2026 results on November 6, 2026, and pointed to a cluster of upcoming milestones for cretostimogene, its investigational oncolytic immunotherapy for non-muscle invasive bladder cancer (NMIBC). The company said PIVOT-006 Phase 3 topline data evaluating cretostimogene monotherapy as an adjuvant therapy in intermediate-risk and high-grade Ta NMIBC is anticipated in November 2026.¹ CEO Arthur Kuan noted that PIVOT-006 is the first randomized registrational trial in intermediate-risk and high-grade Ta NMIBC.¹

The company also said BOND-003 Cohort P and CORE-008 Cohort CX 12-month data are anticipated in December 2026.¹ Separately, BLA completion for BCG-unresponsive NMIBC is anticipated in the fourth quarter of 2026.¹

On the leadership side, CG Oncology strengthened its executive leadership team with the addition of life-science executive Isabel Kalofonos as Chief Commercial Officer in October.¹ The company said Kalofonos brings more than 20 years of experience driving successful launches including PALSONIFY™ (paltusotine) and ELAHERE® (mirvetuximab soravtansine) through strong commercial execution, helping bring innovative therapies to patients at scale across the biotechnology and pharmaceutical industries.¹

On financing, the company reported cash, cash equivalents and marketable securities as of September 30, 2026 were $984.5 million, compared with $1.0 billion as of June 30, 2026.¹ The company said it anticipates its existing cash, cash equivalents and marketable securities as of this date will be sufficient to fund operations through 2029.¹

Cretostimogene's broader program includes a clinical development program with more than 700 patients with NMIBC, including two Phase 3 trials, BOND-003 for BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk and high-grade Ta ≤ 3cm NMIBC.¹ The drug has received FDA Fast Track and Breakthrough Therapy designations for BCG-unresponsive NMIBC.¹