ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) announced that Judge Sheldon K. Rennie denied its post-trial motions for a new trial and judgment as a matter of law regarding the CG Oncology matter on July 16, 2026. The company intends to appeal the rulings to the Delaware Supreme Court to continue seeking the recovery of the value of assets it sold to CG Oncology under the 2010 Agreement. ANI is also pursuing a 5% running royalty on future worldwide sales of cretostimogene grenadenorepvec.

The trial court's decision rejected ANI's claims for unjust enrichment. Nikhil Lalwani, President and Chief Executive Officer at ANI, stated that the company respectfully disagrees with the court's decision and intends to vigorously pursue its legal rights through the appeal process.

Legal Proceedings and Financial Implications

The dispute centers on the 2010 Agreement between ANI Pharmaceuticals and CG Oncology. The following table outlines the key elements of the ongoing legal matter:

The outcome of the appeal could have significant financial implications for ANI Pharmaceuticals, particularly regarding potential royalties from the sales of cretostimogene grenadenorepvec. The company remains focused on its strategy to recover what it believes is the value of the assets sold in 2010.

ANI Pharmaceuticals is a diversified biopharmaceutical company engaged in developing, manufacturing, and commercializing therapeutics. The company operates through its Rare Disease, Generics, and Brands businesses.

ANI Pharmaceuticals, Inc. announced positive topline data from its Phase 4, open-label, single-arm SYNCHRONICITY clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye. The trial met both co-primary endpoints assessing mean change from baseline in best corrected visual acuity (BCVA) letter score and mean change from baseline in central subfield thickness (CST) at 6 months with statistical significance.

SYNCHRONICITY Trial Results

The intent-to-treat (ITT) population included 108 patients. Patients in the ITT population had a mean change in baseline BCVA of +3.6 letters gained (p= <0.0077) at 6 months, with a mean BCVA letter score of 62.5 at baseline compared to 65.8 at month 6. Patients in the ITT population had a mean change in baseline CST of -157.5 microns (p= <.0001) at 6 months, with a mean CST of 505.7 microns at baseline compared to 348.8 microns at month 6.

Safety Profile

The most common adverse events seen in SYNCHRONICITY were consistent with prior trials of the fluocinolone acetonide intravitreal implant. In the safety population, 29% of patients (n=31/108) experienced treatment-related treatment-emergent adverse events; the most common were ocular hypertension in 6% of patients (n=7) and cataract in 5% of patients (n=5). Separately, 18% of patients (n=19/108) experienced an IOP increase of ≥25 mmHg, and 7% of patients (n=8/108) required any laser or surgical IOP-lowering intervention.

Study Design and Population

SYNCHRONICITY was a prospective, Phase 4, open-label, single-arm, two year follow-up study conducted in the U.S. to evaluate the inflammatory control associated with fluocinolone acetonide intravitreal implant, 0.18 mg. Patients enrolled in the study had to have a diagnosis of active, recurrent, unilateral or bilateral NIU-PS with a duration of at least 3 months from initial diagnosis. The study population had a mean age of 64 years and the majority of participants were female (65%). At baseline, 69% of study participants had a history of ocular surgery prior to enrollment.

Future Presentations

Detailed results and additional analyses will be presented at medical conferences in 4Q 2026. The implant is designed to release the corticosteroid fluocinolone acetonide in the eye for up to 36 months.