Delaware Superior Court Jury Issues Unanimous Verdict that CG Oncology Owes No Future Royalties or Other Payments to ANI Pharmaceuticals
CG Oncology (NASDAQ: CGON) has secured a significant legal victory as a Delaware Superior Court jury unanimously ruled in the company's favor regarding a lawsuit filed by ANI Pharmaceuticals in March 2024. The Court determined that CG Oncology will not owe any future royalties on sales of cretostimogene grenadenorepvec, their investigational bladder cancer treatment.
The ruling eliminates a potential 5% royalty obligation on commercial sales and confirms no further payments are due to ANI Pharmaceuticals. This decision follows Judge Sheldon K. Rennie's July 16, 2025 ruling that legally barred ANI Pharmaceuticals from claiming royalties on future cretostimogene sales.
CG Oncology (NASDAQ: CGON) ha ottenuto una vittoria legale significativa: una giuria della Corte Superiore del Delaware ha deciso all'unanimità a favore dell'azienda riguardo a una causa intentata da ANI Pharmaceuticals nel marzo 2024. La Corte ha stabilito che CG Oncology non dovrà corrispondere alcuna royalty futura sulle vendite di cretostimogene grenadenorepvec, il loro trattamento sperimentale per il cancro alla vescica.
La sentenza elimina un potenziale obbligo di royalty del 5% sulle vendite commerciali e conferma che non sono dovuti ulteriori pagamenti ad ANI Pharmaceuticals. Questa decisione segue la sentenza del giudice Sheldon K. Rennie del 16 luglio 2025, che ha legalmente impedito ad ANI Pharmaceuticals di richiedere royalty sulle future vendite di cretostimogene.
CG Oncology (NASDAQ: CGON) ha logrado una victoria legal significativa, ya que un jurado del Tribunal Superior de Delaware falló por unanimidad a favor de la compañía en una demanda presentada por ANI Pharmaceuticals en marzo de 2024. El Tribunal determinó que CG Oncology no deberá pagar regalías futuras por las ventas de cretostimogene grenadenorepvec, su tratamiento experimental para el cáncer de vejiga.
El fallo elimina una posible obligación de regalías del 5% sobre las ventas comerciales y confirma que no se deben más pagos a ANI Pharmaceuticals. Esta decisión sigue a la sentencia del juez Sheldon K. Rennie del 16 de julio de 2025, que prohibió legalmente a ANI Pharmaceuticals reclamar regalías sobre futuras ventas de cretostimogene.
CG Oncology (NASDAQ: CGON)가 중대한 법적 승리를 거두었습니다. 델라웨어 고등법원 배심원단이 2024년 3월 ANI Pharmaceuticals가 제기한 소송과 관련하여 만장일치로 회사의 손을 들어주었습니다. 법원은 CG Oncology가 크레토스티모젠 그레나데노레프벡(방광암 임상 치료제) 판매에 대해 앞으로 로열티를 지불하지 않아도 된다고 판결했습니다.
이번 판결로 상업적 판매에 대한 5% 로열티 의무가 제거되었으며, ANI Pharmaceuticals에 대한 추가 지급 의무가 없음을 확인했습니다. 이 결정은 2025년 7월 16일 Sheldon K. Rennie 판사가 ANI Pharmaceuticals가 향후 크레토스티모젠 판매에 대해 로열티를 청구하지 못하도록 법적으로 금지한 판결에 따른 것입니다.
CG Oncology (NASDAQ : CGON) a remporté une victoire juridique importante, un jury de la Cour supérieure du Delaware ayant statué à l'unanimité en faveur de la société dans une affaire intentée par ANI Pharmaceuticals en mars 2024. Le tribunal a déterminé que CG Oncology ne devra verser aucune redevance future sur les ventes de crétostimogène grenadénorépvec, leur traitement expérimental contre le cancer de la vessie.
Cette décision supprime une éventuelle obligation de redevance de 5 % sur les ventes commerciales et confirme qu'aucun paiement supplémentaire n'est dû à ANI Pharmaceuticals. Cette décision fait suite au jugement du juge Sheldon K. Rennie du 16 juillet 2025, qui a légalement interdit à ANI Pharmaceuticals de réclamer des redevances sur les ventes futures de crétostimogène.
CG Oncology (NASDAQ: CGON) hat einen bedeutenden juristischen Erfolg erzielt, da eine Jury des Delaware Superior Court einstimmig zugunsten des Unternehmens in einem von ANI Pharmaceuticals im März 2024 eingereichten Rechtsstreit entschieden hat. Das Gericht stellte fest, dass CG Oncology keine zukünftigen Lizenzgebühren auf den Verkauf von Cretostimogene Grenadenorepvec, ihrer experimentellen Behandlung gegen Blasenkrebs, zahlen muss.
Das Urteil beseitigt eine potenzielle 5% Lizenzgebührenverpflichtung auf kommerzielle Verkäufe und bestätigt, dass keine weiteren Zahlungen an ANI Pharmaceuticals fällig sind. Diese Entscheidung folgt auf das Urteil von Richter Sheldon K. Rennie vom 16. Juli 2025, das ANI Pharmaceuticals rechtlich untersagte, Lizenzgebühren auf zukünftige Verkäufe von Cretostimogene geltend zu machen.
- None.
- Potential for appeal by ANI Pharmaceuticals creates ongoing legal uncertainty
Insights
CG Oncology wins lawsuit against ANI Pharmaceuticals, eliminating 5% future royalty obligation on their lead bladder cancer drug.
The unanimous jury verdict represents a significant financial victory for CG Oncology, completely eliminating what would have been a substantial future financial burden. By rejecting ANI Pharmaceuticals' claims for unjust enrichment damages and confirming Judge Rennie's earlier ruling that ANI isn't entitled to royalties, the company has removed a 5% royalty obligation that would have impacted all future commercial sales of cretostimogene grenadenorepvec.
This favorable outcome directly strengthens CG Oncology's financial position in two critical ways. First, it preserves the company's future revenue potential from their lead asset, which could represent tens or hundreds of millions in savings over the commercial life of the product. Second, it eliminates ongoing litigation uncertainty that has likely been weighing on investor sentiment.
For biotechnology companies with a primary focus on a single lead asset, royalty obligations can significantly impact profitability margins and commercial competitiveness. The elimination of this 5% royalty requirement will enhance CG Oncology's ability to price its therapy optimally while maintaining stronger margins once commercialized. While ANI Pharmaceuticals might still appeal the decision, this represents a complete first-round legal victory that strengthens CG Oncology's position in any potential settlement discussions.
The verdict allows the company to focus exclusively on the clinical development and potential commercialization of cretostimogene without the distraction and expense of ongoing litigation, potentially accelerating their path to market for this bladder-sparing therapeutic.
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
“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
sarah.connors@cgoncology.com
Investor Relations
Chau Cheng
Vice President, Investor Relations, CG Oncology
(949) 342-8939
chau.cheng@cgoncology.com
FAQ
What was the outcome of the Delaware Court ruling for CG Oncology (NASDAQ: CGON)?
How much in royalties will CG Oncology save from the court verdict?
What is cretostimogene grenadenorepvec being developed for by CG Oncology?
When did ANI Pharmaceuticals file the lawsuit against CG Oncology?
Can ANI Pharmaceuticals appeal the Delaware Court's decision against CGON?
