Protara Therapeutics stock plummets due to trial data release

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Investing.com – Protara Therapeutics Inc (NASDAQ:TARA) stock price fell 19% in after-hours trading on Monday after the company announced the latest interim results from the Phase 2 ADVANCED-2 trial of TARA-002 for high-risk non-muscle invasive bladder cancer patients.

The company reported results for 35 evaluable participants in the BCG non-responder cohort, showing a complete response rate of 68.2% at 6 months and 33.3% at 12 months. In the BCG treatment-naive cohort, which included 29 evaluable participants, as of the data cutoff date of January 28, 2026, the complete response rate was 66.7% at 6 months and 57.9% at 12 months.

TARA-002 is an investigational intravesical cell therapy being evaluated in patients with carcinoma in situ who are BCG non-responders or BCG treatment-naive. The trial showed no treatment-related adverse events of grade 3 or higher, and no related serious adverse events. The most common treatment-related adverse events were dysuria, bladder spasms, fatigue, and urinary urgency, most of which resolved within hours to days.

Among responders in the BCG non-responder cohort, the Kaplan-Meier estimated probability of maintaining a complete response for 6 months was 71.1%. All five patients who maintained response from 9 months to 12 months continued to show complete remission.

Protara expects to complete enrollment of the BCG non-responder cohort in the second half of 2026. Enrollment for the BCG treatment-naive cohort has been completed with 31 patients, and the company plans to initiate the Phase 3 ADVANCED-3 registration trial for BCG-naive patients in the second half of 2026.

These results will be presented on Friday at the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco.

This article was translated with the assistance of artificial intelligence. For more information, please see our Terms of Use.

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