Protara reported interim results from its ADVANCED-2 study of TARA-002 in non-muscle invasive bladder cancer, showing a 68% complete response at six months (n=22) and 33% at 12 months (n=15). Management attributed the 12-month rate to early sample variability and anticipates the durability rate rising toward ~40% as the trial expands to 100 patients before end-2026. The company plans ADVANCED-3, a randomized front-line trial positioning TARA-002 as an alternative when BCG is unavailable or inappropriate.

At the STARBORN-1 study, Protara continues enrollment in its OK-432 derived whole-cell therapeutic for macrocystic and mixed lymphatic malformations, with dosing of 1 KE per injection for up to four doses. The company has scheduled a multi-disciplinary FDA meeting to define a registrational path, targeting approximately 1,000–1,200 new patients annually, and plans separate branding, dosing regimens, and distribution channels distinct from its NMIBC program.

Protara highlighted its intravenous choline chloride program addressing roughly 35,000 U.S. patients on long-term total parenteral nutrition, where THRIVE-1 data showed around 80% choline deficiency and 68% liver injury. The company intends to establish PK and liver-function endpoints in upcoming studies, leveraging an Orange Book-listed patent extending through 2041 to secure market exclusivity.