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CG Oncology, Inc. (CGON)

CG Oncology, Inc., a late-stage clinical biopharmaceutical company, develops and commercializes cretostimogene grenadenorepvec for patients with bladder cancer in the United States. The company’s product candidate is cretostimogene, an investigational oncolytic immunotherapy, which is in phase 2 clinical trials of cretostimogene in patients with high-risk NMIBC after BCG failure; a phase 3 clinical trials to evaluate the safety and efficacy of cretostimogene as monotherapy in the treatment of patients who have received adequate BCG therapy with high-risk BCG-unresponsive, CIS-containing NMIBC and BCG-unresponsive Ta, or T1 papillary tumors; phase 3 BOND-003 Cohort C trials as a single agent; phase 3 BOND-003 Cohort P as a single agent in patients with BCG-UR papillary-only NMIBC. It also develops cretostimogene monotherapy for intermediate-risk NMIBC following TURBT, which is in phase 3 PIVOT-006 clinical trials to assess the safety and efficacy of adjuvant cretostimogene; and cretostimogene monotherapy for high-risk NMIBC in phase 2 CORE-008 clinical trials to assess the safety and clinical outcomes of cretostimogene in treating patients with high-risk NMIBC, including BCG-exposed and BCG-naïve NMIBC. The company was formerly known as Cold Genesys, Inc. and changed its name to CG Oncology, Inc. in June 2020. CG Oncology, Inc. was founded in 2010 and is headquartered in Irvine, California.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

CG Oncology Inc. logo

CG Oncology Inc.

NASDAQ:CGONHealthcare
+1.91%$64.68
AH$64.68+0.00%vs close
Mkt Cap$5.73B
Float68.64M
O/S88.64M
Vol
$ Vol
RVOL
Inst Own-
SI12.9%
Earnings
Dilution
Phase Distribution
8 lead-sponsored trials·3 active·2 completed
Phase 24
Phase 2/31
Phase 32
Not applicable1
(1 more as collaborator)
Status Overview
Recruiting1
Active, not recruiting2
Completed2
Stopped2
Expanded access1

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 3
    Active, not recruiting

    Study of Cretostimogene Given in Patients With Non-Muscle Invasive Bladder Cancer ,Unresponsive to Bacillus-Calmette-Guerin

    Cretostimogene Grenadenorepvec

    Non Muscle Invasive Bladder Cancer, High-grade Ta/ T1 Papillary Disease Bladder Cancer

    Enrollment
    190
    Start
    Oct 2020
    Primary Completion
    Jun 2030est.
    Completion
    Dec 2031est.
    NCT04452591
  • Phase 3
    Active, not recruiting

    A Study of Adjuvant Cretostimogene Grenadenorepvec for Treatment of Intermediate Risk NMIBC Following TURBT

    Cretostimogene Grenadenorepvec

    Non Muscle Invasive Bladder Cancer, Urologic Cancer +2

    Enrollment
    367
    Start
    Dec 2023
    Primary Completion
    Nov 2026est.
    Completion
    Feb 2029est.
    NCT06111235
  • Phase 2/3
    Terminated

    Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer

    CG0070 Adenovirus Vector

    Transitional Cell Carcinoma, Bladder Cancer +2

    Enrollment
    22
    Start
    Mar 2014
    Primary Completion
    Jun 2016
    Completion
    Jun 2016
    NCT01438112
  • Phase 2
    Withdrawn

    Safety and Efficacy of CG0070 Oncolytic Virus Regimen in Patients With High Grade Non-Muscle Invasive Bladder Cancer

    oncolytic adenovirus expressing GMCSF

    Bladder Cancer, High Grade +1

    Enrollment
    0
    Start
    Mar 2014
    Primary Completion
    Mar 2015
    Completion
    Mar 2015
    NCT02143804
  • Phase 2
    Completed

    Safety and Efficacy of CG0070 Oncolytic Virus Regimen for High Grade NMIBC After BCG Failure

    CG0070

    Bladder Cancer

    Enrollment
    66
    Start
    Jun 2015
    Primary Completion
    Aug 2018
    Completion
    Feb 2019
    NCT02365818
  • Phase 2
    Completed

    Study of CG0070 Given in Combination With Pembrolizumab, in Non-Muscle Invasive Bladder Cancer, Unresponsive to Bacillus Calmette-Guerin

    CG0070, Pembrolizumab Injection

    Non Muscle Invasive Bladder Cancer

    Enrollment
    35
    Start
    Dec 2020
    Primary Completion
    Mar 2023
    Completion
    May 2024
    NCT04387461
  • Phase 2
    Recruiting

    Phase 2 Study to Evaluate Safety and Efficacy of Cretostimogene Grenadenorepvec in High-Risk NMIBC

    Cretostimogene Grenadenorepvec

    High-Risk Non-Muscle-Invasive Bladder Cancer

    Enrollment
    325
    Start
    Sep 2024
    Primary Completion
    Mar 2027est.
    Completion
    Dec 2027est.
    NCT06567743
  • Expanded access
    Available

    An Expanded Access Program of Cretostimogene Grenadenorepvec for Treatment of NMIBC for Patients Unresponsive to BCG

    Cretostimogene Grenadenorepvec

    Non-Muscle Invasive Bladder Cancer, Urothelial Carcinoma +2

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT06443944