CG oncology Inc

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CG Oncology, Inc. is a clinical biopharmaceutical company, which engages in the development and commercialization of bladder-sparing therapeutic for patients afflicted with bladder cancer. It offers cretostimogene, a product initially in clinical development for the treatment of patients with Non-Muscle Invasive Bladder Cancer (NMIBC). The company was founded by Alex Yeung and Paul A. DeRidder on September 24, 2010 and is headquartered in Irvine, CA.

IRVINE, Calif., Dec. 16, 2024 (GLOBE NEWSWIRE) -- 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 public offering of 9,200,000 shares of its common stock, 8,500,000 of which were offered by CG Oncology, which includes the exercise in full by the underwriters of their option to purchase 1,200,000 additional shares, and 700,000 of which were offered by an existing stockholder of CG Oncology, each at a public offering price of $28.00 per share.

CG Oncology Announces Closing of Public Offering and Full Exercise of Underwriters' Option to Purchase Additional Shares

CG Oncology, Inc. reported positive phase 3 BOND-003 results for Cretostimogene in treating BCG-unresponsive NMIBC, presented at the SUO 25th Annual Meeting. The company aims to use Cretostimogene as a backbone therapy for NMIBC and has shown increased response rates when combined with KEYTRUDA. CG Oncology plans to expand Cretostimogene's use to intermediate-risk NMIBC patients with the phase 3 PIVOT-006 trial, targeting enrollment completion in 1H 2026.

CG Oncology: Positive Phase 3 Outcome Could Lead To BLA Of Cretostimogene

IRVINE, Calif., Dec. 12, 2024 (GLOBE NEWSWIRE) -- 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 public offering of 8,000,000 shares of its common stock, 7,300,000 of which are being offered by CG Oncology and 700,000 of which are being offered by an existing stockholder of CG Oncology, each at a public offering price of $28.00 per share.

CG Oncology Announces Pricing of Public Offering

IRVINE, Calif., Dec. 11, 2024 (GLOBE NEWSWIRE) -- 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 that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed underwritten public offering of 7,300,000 shares of its common stock.

CG Oncology Announces Proposed Public Offering

An experimental immunotherapy drug is a potentially effective treatment for patients with bladder cancer who no longer respond to current therapies, researchers reported on Thursday at the Society of Urologic Oncology meeting in Dallas.

Health Rounds: Experimental CG Oncology immunotherapy shows promise in bladder cancer

SUO-CTC and CG Oncology Announce the First Annual Non-Muscle Invasive Bladder Cancer (NMIBC) Research Fellowship Award

Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle

Groundbreaking Cretostimogene Grenadenorepvec Monotherapy Data Demonstrates Sustained, Durable Complete Responses in High-Risk BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

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IRVINE, Calif., Aug. 30, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that Arthur Kuan, Chairman & Chief Executive Officer, is scheduled to participate in a fireside chat on Friday, September 6, 2024, at 10:45 am ET, in New York, NY.

CG Oncology to Participate in the Morgan Stanley 22nd Annual Global Healthcare Conference

CG Oncology's bladder cancer molecule, cretostimogene, showed high success with a 75.2% complete response rate in a phase 3 monotherapy study. Cretostimogene, an oncolytic immunotherapy, works by selectively replicating in cancer cells and encoding GM-CSF to activate the immune system. The market potential for cretostimogene is significant, targeting BCG-unresponsive NMIBC patients with a multi-billion dollar opportunity.

CG Oncology: Promising Data, But Looks Expensive

– Final positive safety and efficacy findings from CORE-001 study of Cretostimogene Grenadenorepvec in combination with Pembrolizumab in BCG-Unresponsive NMIBC simultaneously published online by Nature Medicine and featured at ASCO 2024 – – Announced 54% complete response (CR) rate in the intention-to-treat population at 24-month landmark and meets primary endpoint in the CORE-001 study – – Demonstrated 75.2% CR rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer in Cretostimogene Monotherapy BOND-003 study – – Initiated and dosed first patient in Expanded Access Program for Cretostimogene Grenadenorepvec; Enrollment ongoing –  IRVINE, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the second quarter ended June 30, 2024, and provided business updates.

CG Oncology Reports Second Quarter 2024 Financial Results and Provides Business Updates

CG Oncology's cretostimogene shows high potential to disrupt the NMIBC market with promising efficacy and safety data. The company is initially targeting high-risk NMIBC patients who no longer respond to the BCG vaccine, but intermediate-risk patients could bring the addressable market above 60,000. Cretostimogene is the company's only asset and there is likely to be significant competition, most likely from Johnson & Johnson.

CG Oncology Bringing Undervalued Innovation To Bladder Cancer

CG Oncology Announces Nature Medicine Publication of Final Results from CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab

CG Oncology Announces Nature Medicine Publication of Final Results from CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive NMIBC

IRVINE, Calif., May 24, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced final results from the Phase 2 CORE-001 clinical trial of its oncolytic immunotherapy candidate, cretostimogene, in combination with pembrolizumab for the treatment of BCG-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) with Carcinoma in Situ (CIS).

CG Oncology to Present Positive Final Results from Phase 2 CORE-001 Study of Cretostimogene Grenadenorepvec in Combination with Pembrolizumab in BCG-Unresponsive High-Risk NMIBC at ASCO 2024 Annual Meeting

Cretostimogene Monotherapy Demonstrated 75.2% Complete Response (CR) Rate at Any Time in Bacillus Calmette Guerin (BCG)-Unresponsive, High-Risk Non-Muscle Invasive Bladder Cancer (HR-NMIBC) First Patient Dosed in PIVOT-006 Phase 3 Clinical Trial of Cretostimogene in Intermediate-Risk NMIBC (IR-NMIBC) Final Results from CORE-001 Phase 2 Clinical Trial of Cretostimogene in Combination with Pembrolizumab in BCG-Unresponsive HR-NMIBC will be presented at ASCO 2024 Completed Oversubscribed and Upsized $437 Million Initial Public Offering that Extends Expected Runway Through 2027 IRVINE, Calif., May 09, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today reported financial results for the first quarter ended March 31, 2024, and provided business updates.

CG Oncology Reports First Quarter 2024 Financial Results and Provides Business Updates

CG Oncology, Inc. achieved positive results from its phase 3 BOND-003 study using cretostimogene for the treatment of high-risk BCG unresponsive NMIBC patients; Final data expected end of 2024.

CG Oncology: ASCO Play And Top-Line Data End Of 2024 Could Drive Further Value

- Phase 3 BOND-003 study results showed sustained, durable complete responses over 12 months with novel investigational oncolytic immunotherapy - - Company will hold an investor conference call today at 4:30pm EDT - IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a complete response (CR) at any time, as of the cutoff date of April 1, 2024.

Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

IRVINE, Calif., April 26, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, will host a virtual investor event on Friday, May 3, 2024, at 4:30pm EDT.

CG Oncology to Host Virtual Investor Event on Friday, May 3, 2024

IRVINE, Calif., April 24, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. (NASDAQ: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients with bladder cancer, today announced that an abstract with final results of CORE-001, its Phase 2 trial of cretostimogene in combination with pembrolizumab, will be presented at the American Society of Clinical Oncology (ASCO) 2024 Annual Meeting, which will take place from May 31-June 4, 2024, at McCormick Place Convention Center, in Chicago, IL.

CG Oncology to Unveil Encouraging Results on Cretostimogene in Combination with Pembrolizumab at ASCO 2024

- New 12-month data from the Phase 3 BOND-003 trial to be featured in an oral presentation in the Paradigm-shifting, Practice-changing Clinical Trials in Urology plenary session - - New 12-month data from the Phase 3 BOND-003 trial to be featured in an oral presentation in the Paradigm-shifting, Practice-changing Clinical Trials in Urology plenary session -

CG Oncology to Present Results on Cretostimogene at the AUA 2024 Annual Meeting

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