CG Oncology wins Delaware jury trial against ANI Pharmaceuticals

IRVINE, Calif. - CG Oncology, Inc. (NASDAQ:CGON) announced Tuesday that a Delaware Superior Court jury unanimously ruled in its favor in a lawsuit brought by ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) in March 2024. ANI Pharmaceuticals, with a market capitalization of $1.29 billion and showing strong revenue growth of 30% over the last twelve months according to InvestingPro, has been focusing on expanding its pharmaceutical portfolio.

The verdict means CG Oncology will not owe ANI Pharmaceuticals a 5% royalty on future commercial sales of cretostimogene grenadenorepvec, its investigational bladder cancer treatment. The jury rejected all of ANI’s claims for unjust enrichment damages. Despite this setback, ANI maintains a strong financial position with a current ratio of 2.66, indicating solid liquidity to meet its short-term obligations.

This ruling follows a July 16 decision by Judge Sheldon K. Rennie that determined ANI Pharmaceuticals was not entitled to any royalties on future sales of the therapy as a matter of law.

"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," said Arthur Kuan, Chairman and Chief Executive Officer at CG Oncology, according to the company’s press release.

Cretostimogene is an intravesically delivered oncolytic immunotherapy being developed for bladder cancer. The experimental treatment has been studied in more than 400 patients with Non-Muscle Invasive Bladder Cancer (NMIBC) across multiple clinical trials, including two Phase 3 studies.

The therapy is currently being evaluated in the BOND-003 trial for high-risk BCG-unresponsive NMIBC and the PIVOT-006 trial for intermediate-risk NMIBC. The company has also initiated an Expanded Access Program in North America for eligible patients unresponsive to BCG.

It remains unclear whether ANI Pharmaceuticals will appeal any aspect of the decisions, according to the statement released by CG Oncology. Looking ahead, InvestingPro analysis shows ANI is expected to return to profitability this year, with analysts maintaining a positive outlook on the company’s future performance. For deeper insights into ANI Pharmaceuticals and over 1,400 other stocks, including comprehensive Fair Value analysis and expert research reports, investors can access the full suite of tools on InvestingPro.

In other recent news, ANI Pharmaceuticals reported a strong performance for the first quarter of 2025. The company achieved earnings per share of $1.70, surpassing the forecasted $1.34, and generated revenue of $197.1 million, marking a 43% year-over-year increase. This financial success comes amid mixed results from the company’s NEW DAY clinical trial for ILUVIEN in patients with diabetic macular edema. The trial did not meet its primary endpoint, as the mean number of supplemental aflibercept injections required did not reach statistical significance. Despite these trial results, H.C. Wainwright has maintained its Buy rating for ANI Pharmaceuticals with a price target of $84.00. Additionally, ANI Pharmaceuticals announced updates to its stock incentive and employee stock purchase plans following its recent Annual Meeting. These updates include an increase in the number of authorized shares of common stock, which were detailed in the company’s SEC filings.

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