aibioANI loses post-trial motions in CG Oncology royalty case and defends Acella suit
A Delaware court denied ANI's bid for a new trial against CG Oncology on July 16, and ANI plans to appeal. In Minnesota, ANI is defending Acella's Lanham Act suit, with summary judgment argument set for August 25.
Key facts
- Companies
- ANI Pharmaceuticals, Inc. (NASDAQ: ANIP), CG Oncology, Inc. (NASDAQ: CGON)
- News type
- Legal
- Primary source
- ANI Pharmaceuticals 10-Q for the quarter ended June 30, 2026 (SEC EDGAR)
ANI Pharmaceuticals (Nasdaq: ANIP) lost its post-trial motions on July 16, 2026 in its royalty suit against CG Oncology, Inc. (Nasdaq: CGON), according to ANI's 10-Q filed August 7, 2026. The Delaware Superior Court denied ANI's motion for a new trial and for judgment as a matter of law. ANI says it intends to appeal to the Delaware Supreme Court. ANI is also defending a false advertising suit brought by Acella Pharmaceuticals, LLC in federal court in Minnesota.
The parties in the Delaware case are ANI, the plaintiff, and CG Oncology, Inc. f/k/a Cold Genesys, Inc., the defendant, which also counterclaimed. In the Minnesota case the defendant is ANI and the plaintiff is Acella. The 10-Q names no individual defendants in either case.
The case
ANI sued CG Oncology on March 4, 2024. Its complaint alleges that an Assignment and Technology Transfer Agreement dated November 15, 2010 obliges CG Oncology to pay ANI a running royalty of 5 percent of worldwide net sales of cretostimogene, and that CG Oncology wrongfully repudiated that obligation in February 2024. CG Oncology answered and counterclaimed, and ANI added counterclaims for breach and, in the alternative, unjust enrichment.
On July 16, 2025 the court granted CG Oncology partial summary judgment on its counterclaim and defense that the royalty provision is unenforceable under Brulotte, but let ANI's unjust enrichment claim go to trial. A jury trial began July 21, 2025. On July 29, 2025 the jury returned a verdict awarding ANI no damages on unjust enrichment. ANI moved for a new trial on August 12, 2025, and the court heard argument on April 10, 2026 before denying the motions.
Acella sued ANI on March 6, 2024 in the U.S. District Court for the District of Minnesota. Its complaint alleges false advertising under the Lanham Act and unfair trade practices and false advertising under Minnesota law, concerning ANI's natural desiccated thyroid tablets USP. It seeks injunctive relief, damages, disgorgement of profits and fees. ANI denies the claims and has counterclaimed against Acella over its NP Thyroid tablets under the Lanham Act and under Minnesota and Georgia law.
Defendants
Delaware: CG Oncology, Inc. f/k/a Cold Genesys, Inc. is the defendant to ANI's claims, and ANI is the defendant to CG Oncology's counterclaims. Minnesota: ANI is the defendant to Acella's complaint, and Acella is the defendant to ANI's counterclaims. No individuals are named.
Where it stands
CG Oncology's own 10-Q filed August 6, 2026 says that, subject to any appeal, it will not owe ANI a future 5 percent royalty and no further payments are due to ANI under the agreement. It says it will continue to defend any appeals.
In Minnesota, ANI and Acella filed cross motions for summary judgment on April 15, 2026. Fact and expert discovery have closed, the parties have been unable to reach a settlement, and a hearing was set for August 25, 2026. No trial date has been set, and no later ANI filing reports the outcome of the hearing. ANI says it disputes any liability and is defending vigorously.
Why it matters to shareholders
ANI says it cannot predict the outcome of these matters or estimate a range of reasonably possible losses unless it says otherwise, and the 10-Q gives no loss estimate for either case. It adds that its insurance policies have been subject to exclusions for certain classes of drugs, which it says places further risk of financial loss on the company. Legal fees are expensed as incurred.