Protara To Review New Interim Data From Phase 2 Trial Of TARA-002 In Bladder Cancer

(RTTNews) - Protara Therapeutics, Inc. (TARA), a clinical-stage company, is scheduled to host a conference call and live webcast to review new interim data from its phase 2 ADVANCED-2 trial on December 3, 2025.

ADVANCED-2 is a phase 2 trial assessing intravesical TARA-002 in adults 18 years of age or older with high-risk non-muscle invasive bladder cancer (NMIBC), specifically those with carcinoma in situ (CIS) who are BCG-unresponsive or BCG-naïve.

The study includes two cohorts, A and B.

Cohort A:

Participants with CIS who are BCG naive, or Participants with CIS who are BCG exposed and have not received intravesical BCG for at least 24 months before the most recent CIS diagnosis

Cohort B:

Participants with persistent or recurrent CIS who are BCG unresponsive within 12 months of completion of adequate BCG therapy.

Bladder cancer is the 10th leading cause of cancer death in the United States, according to the American Cancer Society. If the tissue that lines the inner surface of the bladder is affected by cancer, it is known as non-muscle invasive bladder cancer.

Bacillus Calmette-Guérin (BCG) is currently the standard intravesical therapy for non-muscle-invasive bladder cancer (NMIBC) as it can prevent disease recurrence and progression and lower mortality. However, some patients do not respond to BCG therapy, and they come under the category known as BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC).

According to the ADVANCED-2 trial results, reported this April, TARA-002 achieved a 100% complete response rate at any time and a 67% complete response rate at 12 months in BCG-Unresponsive patients. Among BCG-naïve patients, TARA-002 demonstrated a 76% complete response rate at any time and a 43% complete response rate at 12 months.

During the conference call, the company will also provide an update on the feedback from the FDA on a registrational path forward for TARA-002 in BCG-Naïve patients.

TARA closed Monday's trading at $6.74, down 8.67%.