CG Oncology gets an intermediate-risk bladder boost

CG Oncology is bucking the clinical trial delay trend, announcing on Friday that the Pivot-006 study of its bladder cancer candidate cretostimogene grenadenorepvec would read out in the first half of 2026. The trial had previously been expected to yield data in 2027.

Pivot-006 tests the oncolytic virus as adjuvant therapy, versus surveillance, in patients with intermediate-risk non-muscle invasive bladder cancer. There isn’t yet much competition here, with UroGen’s Zusduri approved last year for intermediate-risk disease, based on a single-arm trial. However, Johnson & Johnson has important bladder cancer ambitions, and also hopes to make a mark here with its erdafitinib-releasing project TAR-210.

Still, investors took the news as a good omen, and CG’s stock closed up 29% on Friday – giving the group a market cap of around $4.4bn.

High vs intermediate-risk

NMIBC accounts for 75% of bladder cancers, with around a third of patients deemed high-risk, and another third intermediate-risk. Much of the recent activity has been in high-risk disease, specifically the BCG-unresponsive setting, where J&J’s gemcitabine-eluting Inlexzo got the FDA nod last September, joining ImmunityBio’s Anktiva, Ferring’s Adstiladrin and Merck & Co’s Keytruda.

Intermediate-risk disease is earlier stage, and could become the next big battleground for bladder cancer, according to Jones Research.

So far UroGen’s intravesical mitomycin formulation has the FDA green light for recurrent disease, but approval was controversial, being based on a single-arm trial, Envision. The lack of a randomised study led to an FDA adcom voting 4-5 against the drug's approval.

CG’s Pivot-006 study is in a different setting, testing adjuvant creto-G, making it difficult to benchmark the results. Following transurethral tumour resection, patients were randomised to receive creto-G or observation; subjects can cross over from the surveillance cohort into the treatment arm on recurrence. The primary endpoint is recurrence-free survival.

Topline data had once been expected in 2027, but CG said the study enrolled more quickly than expected.

Competition 

Various other groups are also targeting intermediate-risk NMIBC, but CG’s biggest competition could come from J&J, whose TAR-210 is in the Moonrise-1 trial in this setting. Still, that’s not set to complete until 2028, and it’s also restricted to patients with FGFR alterations; erdafitinib is an FGFR inhibitor, and an oral formulation is already marketed by J&J as Balversa.

Also focusing on FGFR-altered patients is Tyra Biosciences, whose selective FGFR3 inhibitor dabogratinib (TYRA-300) is in the phase 2 Surf-302 trial in intermediate-risk disease. Topline results are expected this half.

In 2024 Ferring also began the Able-32 phase 3 trial of its gene therapy Adstilatrin in intermediate-risk NMIBC, an attempt to expand beyond that therapy’s high-risk BCG-unresponsive NMIBC label.

The BCG-unresponsive setting is where CG’s creto-G could get its first FDA approval, based on the Bond-003 trial. The company began a rolling BLA submission in 2025, and this is set to complete this year.

The intermediate-risk (IR) NMIBC landscape

Source: OncologyPipeline & Jones Research note, 9 Jan 2026.