CG Oncology, Inc. 8-K

What Happened

• On January 9, 2026, CG Oncology (CGON) issued a press release and updated its investor presentation announcing an expedited timeline for topline results from PIVOT-006, its Phase 3 trial in intermediate-risk non‑muscle invasive bladder cancer (IR NMIBC). Topline data are now expected in the first half of 2026.
• The company also reported topline results from December 2025 for earlier-stage trials: BOND-003 Cohort P (BCG-unresponsive papillary-only NMIBC) and CORE-008 Cohort A (high-risk, BCG‑naïve NMIBC with CIS), showing encouraging efficacy and a favorable safety profile for cretostimogene grenadenorepvec (cretostimogene).

Key Details

• PIVOT-006: Phase 3 randomized trial comparing adjuvant intravesical cretostimogene vs surveillance in IR NMIBC; company notes U.S. intermediate-risk population estimated >50,000 patients. Topline readout expected H1 2026.
• BOND-003 Cohort P (data cut-off Sept 1, 2025): in 51 evaluable patients, Kaplan‑Meier High-Grade Event‑Free Survival (HG‑EFS) was 95.7% at 3 months, 84.6% at 6 months, and 80.4% at 9 months. No Grade ≥3 treatment‑related adverse events (TRAEs), no deaths, no radical cystectomies or progression to muscle‑invasive disease; study enrollment completed with 56 treated patients across 35 U.S. and Japan sites.
• CORE-008 Cohort A (data cut-off Sept 1, 2025): overall Complete Response (CR) rate at any time in evaluable patients was 83.7% (41/49). CR by administration: original (five‑step) 79.2% (19/24); optimized (two‑step) 88.0% (22/25). Safety: no related serious adverse events, no Grade ≥3 AEs, and no treatment‑related discontinuations.

Why It Matters

• An H1 2026 topline readout from the PIVOT‑006 Phase 3 trial is a near‑term clinical milestone that could materially affect CG Oncology’s regulatory and commercial outlook for cretostimogene in a sizable intermediate‑risk NMIBC population.
• The reported BOND‑003 and CORE‑008 topline results show strong early efficacy signals and a tolerable safety profile across multiple NMIBC settings, which investors typically view as supportive when assessing the drug’s development progress and risk profile.
• The company noted these are forward‑looking expectations; actual outcomes and regulatory paths depend on full data, ongoing analyses, and standard clinical and regulatory risks.