Protara Therapeutics Announces Positive Updated 12-Month Data Demonstrating Durable Responses in the Fully Enrolled BCG-Naïve Cohort of the Ongoing Phase 2 ADVANCED-2 Trial of TARA-002 in NMIBC

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TARA-002 demonstrates 72% complete response rate at any time, 67% complete response rate at the 6-month landmark and 55% complete response rate at the 12-month landmark in BCG-Naïve patients Favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events Company remains on track to initiate the ADVANCED-3 registrational trial in BCG-Naïve patients in 2H 2026 NEW YORK, May 15, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today announced positive updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC). These results in Bacillus Calmette-Guérin (BCG)-Naïve NMIBC patients will be featured today during a poster session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C. “Today’s presentation demonstrates TARA-002’s impressive 12-month durability data and excellent safety profile for patients with BCG-Naïve NMIBC,” said Mark Tyson, M.D., Professor of Urology, Mayo Clinic Phoenix, and ADVANCED-2 study investigator. “The NMIBC patient community faces a critical unmet need for safe, effective and bladder-sparing treatment options for this devastating disease. These compelling data, coupled with a simple, streamlined administration for both physicians and patients, make TARA-002 a potentially important new treatment option for BCG-Naïve high risk NMIBC patients.” “These data continue to support our conviction that TARA-002 has the potential to make a meaningful difference in the lives of patients with BCG-Naïve NMIBC,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “Notably, the durable 12-month complete response (CR) rate observed in the BCG-Naïve cohort continues to perform competitively among approved treatments and investigational therapies in development. We look forward to completing enrollment in the registrational BCG-Unresponsive cohort of ADVANCED-2 and initiating ADVANCED-3, a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-Naïve and potentially BCG-Exposed patients in the second half of 2026.” Updated Data Results in BCG-Naïve Patients Efficacy Th...

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