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CGON CG Oncology

CG Oncology Inc is a late-stage clinical biopharmaceutical company focused on developing and commercializing its product candidate, cretostimogene grenadenorepvec, for patients with bladder cancer. The company's candidate, cretostimogene grenadenorepvec, is a targeted oncolytic intravesically delivered immunotherapy ag…

Assets on file: cretostimogene grenadenorepvec

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Catalyst calendar

Dated catalysts for CGON, including recently decided ones.

November 2026

Nov 2026

~ Nov 2026

CGONCG Oncology

cretostimogene grenadenorepvec: Phase 3 trial NCT06111235 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

March 2027

Mar 2027

Mar 31, 2027

in 151 days

CGONCG Oncology

cretostimogene grenadenorepvec: Phase 2 trial NCT06567743 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

December 2027

Dec 2027

Dec 31, 2027

in 426 days

CGONCG Oncology

cretostimogene grenadenorepvec: Phase 2 trial NCT07283835 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

June 2030

Jun 2030

Jun 16, 2030

in 1324 days

CGONCG Oncology

cretostimogene grenadenorepvec: Phase 3 trial NCT04452591 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.gov

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Decision-gradeMaterialNotableMinor

Jul 27, 2026

10:45 PM

CGONCG Oncology

CG Oncology: BOND-003 Phase 3 topline published in The Lancet Oncology

The pivotal Phase 3 BOND-003 Cohort C results for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with CIS were published in The Lancet Oncology. The trial met its primary endpoint with a 75.5% complete response rate and a median duration of response of at least 27.9 months. These data support the ongoing BLA submission and potential FDA approval for this indication.

Topline resultsCompany press release Open record

Nov 14, 2025

01:15 PM

CGONCG Oncology

CG Oncology initiates rolling BLA for cretostimogene in HR BCG-unresponsive NMIBC

CG Oncology began a rolling BLA submission to FDA for cretostimogene monotherapy in high-risk BCG-unresponsive NMIBC with CIS ± Ta/T1 disease. The company expects to complete the submission in 2026 and already holds Fast Track and Breakthrough Therapy designations. No PDUFA date or advisory-committee date is stated in the release.

Application submittedSEC 8-K Open record