CG Oncology won a lawsuit against ANI Pharmaceuticals, eliminating future royalty payments for its cancer treatment, cretostimogene.
Quiver AI Summary
CG Oncology, Inc. announced a significant legal victory as a jury in Delaware ruled in favor of the company in a lawsuit filed by ANI Pharmaceuticals regarding royalties on their investigational bladder cancer therapy, cretostimogene grenadenorepvec. The jury unanimously dismissed ANI's claims for unjust enrichment damages and confirmed that ANI is not entitled to a future 5% royalty on cretostimogene sales. This ruling allows CG Oncology to focus on its mission of developing bladder-sparing treatment options for patients. The company is advancing cretostimogene through multiple clinical trials aimed at non-muscle-invasive bladder cancer (NMIBC) and has also initiated an Expanded Access Program for eligible patients.
Potential Positives
- CG Oncology achieved a significant legal victory by having a jury unanimously rule in its favor against ANI Pharmaceuticals, entirely rejecting ANI's claims for unjust enrichment damages.
- The court's decision means CG Oncology will not owe ANI Pharmaceuticals a future royalty of 5% on commercial sales of cretostimogene, allowing the company to allocate more resources towards its core mission of developing bladder cancer treatments.
- This legal outcome reinforces CG Oncology's focus and commitment to advancing its investigational oncolytic immunotherapy, cretostimogene, aimed at improving the quality of life for bladder cancer patients.
Potential Negatives
- Despite winning the lawsuit, the company remains vulnerable to potential appeals from ANI Pharmaceuticals, which could prolong legal uncertainties and impact investor confidence.
- The press release heavily emphasizes the uncertainty surrounding the development of cretostimogene, specifically mentioning risks like unexpected adverse side effects, inadequate efficacy, and potential delays in clinical trials, which may concern stakeholders about the product's future.
- The ongoing reliance on third parties for manufacturing and clinical testing introduces additional risks that could hinder the company's progress and operational capabilities.
FAQ
What was the lawsuit outcome for CG Oncology against ANI Pharmaceuticals?
CG Oncology won unanimously on all claims in the lawsuit, with the jury rejecting ANI's claims for unjust enrichment damages.
What is cretostimogene grenadenorepvec?
Cretostimogene is an investigational oncolytic immunotherapy currently being developed for bladder cancer treatment.
How does the ruling affect CG Oncology’s future royalties?
CG Oncology will not owe ANI Pharmaceuticals a future royalty of 5% on sales of cretostimogene, which is a significant victory.
What clinical trials are associated with cretostimogene?
Cretostimogene is involved in two Phase 3 trials, BOND-003 and PIVOT-006, and a Phase 2 trial, CORE-008, for bladder cancer.
Where can I find more information about CG Oncology?
More information about CG Oncology can be found on their official website: www.cgoncology.com.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CGON Insider Trading Activity
$CGON insiders have traded $CGON stock on the open market 4 times in the past 6 months. Of those trades, 0 have been purchases and 4 have been sales.
Here’s a breakdown of recent trading of $CGON stock by insiders over the last 6 months:
- LEONARD E POST has made 0 purchases and 4 sales selling 5,000 shares for an estimated $142,760.
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$CGON Hedge Fund Activity
We have seen 86 institutional investors add shares of $CGON stock to their portfolio, and 56 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- POINT72 ASSET MANAGEMENT, L.P. added 1,358,915 shares (+440.8%) to their portfolio in Q1 2025, for an estimated $33,279,828
- ORBIMED ADVISORS LLC added 1,040,880 shares (+72.7%) to their portfolio in Q1 2025, for an estimated $25,491,151
- MARSHALL WACE, LLP added 960,384 shares (+65.9%) to their portfolio in Q1 2025, for an estimated $23,519,804
- AVORO CAPITAL ADVISORS LLC removed 700,000 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $17,143,000
- UBS GROUP AG added 690,827 shares (+68.1%) to their portfolio in Q1 2025, for an estimated $16,918,353
- PERCEPTIVE ADVISORS LLC removed 419,450 shares (-100.0%) from their portfolio in Q1 2025, for an estimated $10,272,330
- MILLENNIUM MANAGEMENT LLC added 347,055 shares (+139.4%) to their portfolio in Q1 2025, for an estimated $8,499,376
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$CGON Analyst Ratings
Wall Street analysts have issued reports on $CGON in the last several months. We have seen 5 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- RBC Capital issued a "Outperform" rating on 07/16/2025
- Morgan Stanley issued a "Overweight" rating on 06/17/2025
- JP Morgan issued a "Overweight" rating on 05/02/2025
- Cantor Fitzgerald issued a "Overweight" rating on 04/28/2025
- HC Wainwright & Co. issued a "Buy" rating on 04/28/2025
To track analyst ratings and price targets for $CGON, check out Quiver Quantitative's $CGON forecast page.
$CGON Price Targets
Multiple analysts have issued price targets for $CGON recently. We have seen 7 analysts offer price targets for $CGON in the last 6 months, with a median target of $56.0.
Here are some recent targets:
- Leonid Timashev from RBC Capital set a target price of $53.0 on 07/16/2025
- Jeffrey Hung from Morgan Stanley set a target price of $56.0 on 06/17/2025
- Brian Cheng from JP Morgan set a target price of $41.0 on 05/02/2025
- Josh Schimmer from Cantor Fitzgerald set a target price of $75.0 on 04/28/2025
- Andres Maldonado from HC Wainwright & Co. set a target price of $75.0 on 04/28/2025
- An analyst from Scotiabank set a target price of $23.0 on 04/16/2025
Full Release
IRVINE, Calif., July 29, 2025 (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 a jury in the Superior Court of the State of Delaware (the “Court”) unanimously found in favor of CG Oncology on all claims in a March 2024 lawsuit brought by ANI Pharmaceuticals, Inc. (Nasdaq: ANIP) (“ANI”). The jury unanimously rejected all of ANI Pharmaceuticals’ claims for unjust enrichment damages after Judge Sheldon K. Rennie, on July 16, 2025, had ruled in favor of CG Oncology that, as a matter of law, ANI Pharmaceuticals was not entitled to any royalties on future sales of cretostimogene grenadenorepvec. At present CG Oncology has not been advised as to whether ANI Pharmaceuticals will appeal any aspect of the decisions. As a result of today’s decision CG Oncology will not owe ANI Pharmaceuticals a future royalty of 5% on commercial sales of cretostimogene and there are no further payments due to ANI Pharmaceuticals for damages. Cretostimogene is CG Oncology’s investigational, intravesically delivered oncolytic immunotherapy in development for bladder cancer.
“CG Oncology thanks both Judge Rennie and the jury for their thoughtful evaluation and decisions in the case which represent a major victory for bladder cancer patients who could benefit from cretostimogene,” said Arthur Kuan, Chairman & Chief Executive Officer at CG Oncology. “The decisions allow CG Oncology to continue to focus our resources and energy on delivering on our mission to bring forward innovative immunotherapies that help bladder cancer patients live with dignity and have an enhanced quality of life.”
About Cretostimogene Grenadenorepvec
Cretostimogene is an investigational, intravesically delivered oncolytic immunotherapy that has been studied in a clinical development program, which includes more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC). This program includes two Phase 3 clinical trials: BOND-003 for high-risk BCG-unresponsive NMIBC and PIVOT-006 for intermediate-risk NMIBC. CG Oncology also has a Phase 2 trial, CORE-008, evaluating the safety and efficacy of cretostimogene in high-risk NMIBC. Additionally, we have initiated an Expanded Access Program for cretostimogene in North America for patients who are unresponsive to BCG and meet certain program eligibility requirements. Cretostimogene is an investigational candidate, and its safety and efficacy have not been established by the FDA or any other health authority.
About CG Oncology
CG Oncology is a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer. CG Oncology sees a world where urologic cancer patients may benefit from our innovative immunotherapies to live with dignity and have an enhanced quality of life. To learn more, please visit: www.cgoncology.com.
Forward-Looking Statements
CG Oncology cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding our anticipated cash runway, future results of operations and financial position; the anticipated timing and conduct of our ongoing and planned clinical trials and preclinical studies for cretostimogene, including anticipated next milestones in our development pipeline; the timing and likelihood of regulatory filings and approvals for cretostimogene; and the potential therapeutic benefits of cretostimogene for high-risk and intermediate-risk NMIBC patients. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: interim results of a clinical trial are not necessarily indicative of final results and one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data becomes available; potential delays in the commencement, enrollment and completion of clinical trials, including the BOND-003 and PIVOT-006 trials; we may use our capital resources sooner than expected and they may be insufficient to allow us to achieve our anticipated milestones; our dependence on third parties in connection with manufacturing, shipping and clinical and preclinical testing; results from earlier clinical trials and preclinical studies not necessarily being predictive of future results; unexpected adverse side effects or inadequate efficacy of cretostimogene that may limit its development, regulatory approval, and/or commercialization; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K and other filings that we make with the SEC from time to time (which are available at http://www.sec.gov). You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contacts:
Media
Sarah Connors
Vice President, Communications and Patient Advocacy, CG Oncology
(508) 654-2277
[email protected]
Investor Relations
Chau Cheng
Vice President, Investor Relations, CG Oncology
(949) 342-8939
[email protected]