Price Target and Market Performance: Morgan Stanley set a price target of $93 for NASDAQ:CGON, indicating a potential increase of about 71.59% from its current trading price.Strong Buy Rating: CG Oncology received a "Strong Buy" rating due to its pipeline progress and upcoming catalysts, particularly for its bladder cancer treatments.Key Developments and FDA Approval Potential: The company's early completion of enrollment in the phase 3 PIVOT-006 trial and the rolling BLA for cretostimogene highlight signif ...

Core Insights - CG Oncology has appointed Christina Rossi, an experienced life sciences executive, to its Board of Directors, while Simone Song has resigned from the Board [1][2] - The company is at a pivotal moment with the initiation of the Biologics License Application (BLA) for cretostimogene, aiming for a successful launch upon FDA approval [2] - Cretostimogene is an investigational oncolytic immunotherapy being studied in over 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC) through multiple clinical trials [4] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing a bladder-sparing therapeutic for bladder cancer patients [5] - The company aims to enhance the quality of life for urologic cancer patients through innovative immunotherapies [5] Executive Background - Christina Rossi has over 25 years of experience in the pharmaceutical and biotechnology sectors, previously serving as COO of Blueprint Medicines and holding various leadership roles at Sanofi Genzyme and Biogen [3] - Rossi's expertise includes overseeing commercial launches and optimizing operations to improve patient access to therapies [3]

Core Insights - CG Oncology, Inc. is advancing its lead therapeutic candidate, cretostimogene, for bladder cancer, with a focus on high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [2][6][10] - The company has initiated a rolling Biologics License Application (BLA) submission to the U.S. FDA, with complete submission expected in 2026 [6][7] - Financial results for Q3 2025 show a net loss of $43.8 million, an increase from $20.4 million in Q3 2024, attributed to rising R&D and G&A expenses [12][14] Corporate Highlights - The company reported a cash position of $680.3 million as of September 30, 2025, an increase from $661.1 million as of June 30, 2025, providing sufficient funds to support operations into the first half of 2028 [5][8] - Cretostimogene has received Fast Track and Breakthrough Therapy Designations, aimed at expediting its regulatory review process [7] Anticipated Upcoming Milestones - Topline data from the BOND-003 Cohort P trial is expected in Q4 2025, focusing on HR BCG-unresponsive NMIBC without CIS [7] - Initial results from the CORE-008 Cohort A trial are also anticipated in Q4 2025, targeting HR BCG-naïve NMIBC [7] Financial Highlights - Total revenues for Q3 2025 were $1.666 million, compared to $43,000 in Q3 2024, with commercial and development revenue of $1.508 million [14] - R&D expenses increased to $27.9 million in Q3 2025 from $19.6 million in Q3 2024, primarily due to higher clinical trial costs [12][14] - G&A expenses rose to $23.3 million in Q3 2025 from $8.7 million in Q3 2024, driven by increased legal and professional fees [12][14]

Group 1 - CG Oncology, Inc. (NASDAQ:CGON) is recognized as one of the best healthcare stocks with significant upside potential, receiving a Buy rating and a $90 price target from Guggenheim analyst Brad Canino [1] - The company is positioned favorably in the non-muscle invasive bladder cancer market, which is characterized by considerable pricing power and a substantial patient base, contributing to the optimistic outlook for CG Oncology [2] - CG Oncology's product, cretostimogene, is set to enter FDA review in 2026, noted for its "best-in-class" efficacy and safety durability, which are critical factors for its investment appeal [3] Group 2 - CG Oncology, Inc. is a clinical biopharmaceutical company focused on developing and commercializing bladder-sparing therapeutics specifically for bladder cancer, with cretostimogene currently in clinical development for Non-Muscle Invasive Bladder Cancer (NMIBC) [4] - The company is advancing its pipeline to establish a potential backbone therapy for NMIBC, emphasizing a strong tolerability profile and safety that could lead to durable, complete responses in bladder cancer patients [4]

Core Insights - CG Oncology Inc. (NASDAQ:CGON) is recognized as a promising investment opportunity, with Guggenheim analyst Brad Canino initiating coverage with a Buy rating and a price target of $90, citing the significant patient population and pricing power in the non-muscle invasive bladder cancer market [1][3] - The company is developing cretostimogene grenadenorepvec, an investigational oncolytic immunotherapy aimed at providing bladder-sparing treatment for non-muscle invasive bladder cancer (NMIBC) [2][4] - CG Oncology has initiated the CORE-008 Cohort CX trial to evaluate the combination of cretostimogene and gemcitabine in high-risk NMIBC patients, with key upcoming milestones including the completion of Phase 3 enrollment for the PIVOT-006 trial in Q3 and the initiation of a Biologics License Application (BLA) submission for cretostimogene in Q4 [3] Company Overview - CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing bladder-sparing therapeutics for bladder cancer patients [4]

Core Viewpoint - CG Oncology is a clinical-stage biotech company focused on developing treatments for non-muscle invasive bladder cancer (NMIBC), with a recent bullish research report boosting its share price significantly [1][2][3]. Company Overview - CG Oncology is currently concentrated on one type of cancer, NMIBC, and has a promising drug candidate, cretostimogene, which has shown efficacy and safety in clinical trials [3][4]. - The company has received a buy rating from Guggenheim with a price target of $90 per share, indicating a potential for more than double the current share price [2]. Market Potential - There is a large addressable market for NMIBC treatments, and a successful drug could provide significant pricing power for CG Oncology [4]. - The company is expected to seek FDA approval for its investigational drug next year, which adds to the optimism surrounding its prospects [5].

Core Insights - CG Oncology is advancing cretostimogene as a potential backbone therapy for non-muscle invasive bladder cancer (NMIBC), with plans to submit a Biologics License Application (BLA) in the second half of 2025 [2][4] - The company reported a net loss of $34.5 million for Q1 2025, an increase from $16.9 million in Q1 2024, primarily due to rising research and development expenses [11][15] - Cash and cash equivalents as of March 31, 2025, were $688.4 million, down from $742.0 million at the end of 2024, with sufficient funds projected to last into the first half of 2028 [5] Clinical Development Updates - The BOND-003 trial showed a 24-month complete response rate of 42.3% for Cohort C, with a 75.5% complete response at any time [6][7] - Cohort P demonstrated a promising 90.5% high-grade recurrence-free survival at 3 and 9 months [6][7] - The CORE-008 trial has been initiated to evaluate the combination of cretostimogene and gemcitabine in high-risk BCG-exposed NMIBC patients [6][7] Financial Performance - Research and development expenses for Q1 2025 were $27.5 million, up from $17.2 million in Q1 2024, driven by increased clinical trial costs and headcount [11] - General and administrative expenses rose to $14.8 million in Q1 2025 from $5.8 million in Q1 2024, attributed to higher personnel-related costs and professional fees [11] - License and collaboration revenue decreased to $52,000 in Q1 2025 from $529,000 in Q1 2024 [15] Future Milestones - The company anticipates completing enrollment for the Phase 3 PIVOT-006 trial in the second half of 2025 [6][4] - The initiation of the BLA submission for cretostimogene monotherapy in HR BCG-unresponsive NMIBC is expected [6][7] - Topline data from ongoing clinical trials, including CORE-008 and BOND-003, are anticipated in the near future [6][7]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Table of Contents As filed with the Securities and Exchange Commission on January 23, 2024 Registration No. 333-276350 Washington, D.C. 20549 AMENDMENT NO.2 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 37-1611499 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identi ...

Table of Contents As filed with the Securities and Exchange Commission on January 18, 2024 Registration No. 333-276350 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO.1 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 37-1611499 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identi ...

Table of Contents As filed with the Securities and Exchange Commission on January 2, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 CG ONCOLOGY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2836 37-1611499 (I.R.S. Employer Identification No.) 400 Spec ...