Articles from CG Oncology, Inc.

CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the closing of its upsized initial public offering of 23,000,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase 3,000,000 additional shares, at an initial public offering price of $19.00 per share. All of the shares were offered by CG Oncology. The aggregate gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, were $437.0 million. CG Oncology’s common stock is listed on the Nasdaq Global Select Market under the ticker symbol “CGON.”

CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, today announced the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share. All of the shares are being offered by CG Oncology. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $380.0 million. CG Oncology’s common stock is expected to begin trading on the Nasdaq Global Select Market on January 25, 2024 under the ticker symbol “CGON.” The offering is expected to close on January 29, 2024, subject to the satisfaction of customary closing conditions. In addition, CG Oncology has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

CG Oncology, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted both Fast Track Designation and Breakthrough Therapy Designation for cretostimogene grenadenorepvec in high-risk Bacillus Calmette-Guérin (BCG)-unresponsive Non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ with or without Ta or T1 (papillary) tumors.

CG Oncology, Inc. today announced that Phase 3 monotherapy data from the BOND-003 clinical trial evaluating the efficacy and safety of cretostimogene grenadenorepvec in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG), showed that 75.7% of evaluable patients achieved a complete response (CR) at any time, as of the cutoff date of October 5, 2023. These data will be featured today in a Late-Breaking Oral Podium Presentation (Abstract #LBA3396) by Mark D. Tyson, M.D., urologic oncologist at Mayo Clinic, at the 24th Annual Meeting of the Society of Urological Oncology (SUO) taking place November 28 – December 1, 2023 in Washington, DC.

CG Oncology, Inc. announced today that interim Phase 3 monotherapy data from the BOND-003 study will be presented as a late-breaking abstract at the upcoming 24th Annual Meeting of the Society of Urologic Oncology (SUO), held November 28-December 1, 2023, at the Omni Shoreham Hotel in Washington, DC.

CG Oncology, Inc. today announced the appointment of three new members to its executive leadership team: Ambaw Bellete as President and Chief Operating Officer, Swapnil Bhargava, Ph.D. as Chief Technical Officer, and Vijay Kasturi, M.D. as Chief Medical Officer.

CG Oncology, Inc., announced today completion of patient enrollment for BOND-003, a single arm, Phase 3, monotherapy study evaluating cretostimogene grenadenorepvec in patients with high-risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

CG Oncology, Inc. announced updated data from the CORE-001 study, an ongoing Phase 2 clinical trial of cretostimogene grenadenorepvec (CG0070) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

CG Oncology, Inc. today announced acceptance of an oral presentation at the American Urological Association (AUA) 2023 Annual Meeting in Chicago, IL from April 28-May 1, 2023. The updated data will be presented from the CORE-001 study, an ongoing Phase 2 clinical trial of cretostimogene grenadenorepvec (CG0070) in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, today announced that Arthur Kuan, Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference in San Francisco, California on Wednesday, January 11, 2023 at 4pm Pacific Standard Time. The presentation will be webcast live and available for replay from the news section of CG Oncology’s website at www.cgoncology.com.

CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, today announced the close of an oversubscribed $120 million Series E financing round, co-led by ORI Capital, Longitude Capital and Decheng Capital, with participation from RA Capital Management, Acorn Bioventures, Malin Corporation, Ally Bridge Group and Sirona Capital. The company has secured a total of over $200 million in funding to date. In connection with the financing, Brian Liu, M.D., Principal from Longitude Capital, will join the company’s board of directors.

CG Oncology, Inc., an oncolytic immunotherapy company focused on developing novel therapeutics for patients with urologic cancers, today announced new updated data from its global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG).

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, today announced interim data on two ongoing clinical studies will be presented at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced interim results from the global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced interim results from the global Phase 2 study (CORE1) of CG0070 in combination with Merck’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced today it has triggered the first development milestone payment under its licensing agreement with Kissei Pharmaceutical Co., Ltd. for its oncology immunotherapy CG0070 for Japan, South Korea, Taiwan and other Asian countries with the exception of China.

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, today announced preliminary Phase 2 study (CORE1) results for CG0070 in combination with KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG).

CG Oncology, Inc., a clinical-stage biotechnology company focused on developing oncolytic immunotherapies for patients with advanced cancer, announced today acceptance of an oral presentation and a poster presentation at The Society for Immunotherapy of Cancer (SITC) Annual Meeting, held virtually and in-person in Washington, DC, November 10-14, 2021.

CG Oncology, Inc. announced today that it has entered into a clinical trial collaboration agreement to evaluate the combination of CG Oncology’s investigational oncolytic immunotherapy CG0070, with Roche’s atezolizumab, an anti-PD-L1 (programmed death-ligand 1) therapy.

CG Oncology, Inc. today announced a clinical trial collaboration to evaluate the safety and efficacy of CG0070, an oncolytic immunotherapy, in combination with OPDIVO® (nivolumab), Bristol Myers Squibb’s anti-PD-1 therapy, for the treatment of metastatic urothelial cancer in a Phase 1/2 clinical study.