Protara Reports Positive Phase 2 Data For TARA-002 In Bladder Cancer Study

(RTTNews) - Protara Therapeutics, Inc. (TARA) on Friday announced positive updated 12-month data from the Phase 2 ADVANCED-2 study evaluating TARA-002 in certain patients with non-muscle invasive bladder cancer (NMIBC).

The study is evaluating intravesical TARA-002 in patients with carcinoma in situ who are Bacillus Calmette-Guérin (BCG)-unresponsive or BCG-naïve.

Results from Cohort A showed a complete response rate of 72.4% in BCG-naïve patients at any time during the study. The complete response rate was 66.7% at six months and 55.0% at 12 months.

Among responders, the Kaplan-Meier estimated probability of maintaining a complete response for six months was 73.1%, while 91.7% of patients maintained their complete response from nine to 12 months.

The company said most treatment-related adverse events were Grade 1 and transient, with no Grade 3 or higher treatment-related adverse events reported.

Protara added that it remains on track to initiate the ADVANCED-3 registrational trial in BCG-naïve patients in the second half of 2026.

The company's shares were down more than 1% in pre-market trading after closing at $5.30 on Thursday.