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Investing.com -- Shares of Protara Therapeutics, Inc. (NASDAQ:TARA) tumbled 19% after the company released interim results from its ongoing Phase 2 ADVANCED-2 trial of TARA-002 in patients with Non-Muscle Invasive Bladder Cancer (NMIBC). Despite demonstrating a 100% complete response rate at any time and a 67% 12-month landmark complete response rate in BCG-Unresponsive patients, investors appeared skeptical, leading to the stock’s decline.
The trial’s interim data, presented at the American Urological Association 2025 Annual Meeting, showed promising efficacy and safety profiles for TARA-002, with no Grade 3 or greater treatment-related adverse events reported. The BCG-Naïve patient cohort also showed a 76% complete response rate at any time and a 43% 12-month landmark complete response rate.
Analysts have weighed in on the results, with TD Cowen’s Stacy Ku, Ph.D., commenting, "TARA-002’s ~67% 12-month CRR in BCG-unresponsive NMIBC patients appear competitive, with a clean safety profile. Although early we are encouraged, as the efficacy looks promising. With solid patient enrollment progress, the key Phase II futility analysis for BCG-unresponsive patients is on-track for YE. The most significant opportunity for ’002 is NMIBC, with a high unmet need to avoid cystectomy."
Cantor analyst Li Watsek also provided a positive outlook, stating, "The update from the Ph2 ADVANCED-2 of TARA-002 in NMIBC at AUA this weekend gave us greater confidence of a viable contender. Small N aside, any-time CR rate has improved to 100% from prior 80% in BCG-unresponsive patients. Importantly, the first look at the 12-mon CR rate of 67% compares well vs. ~50% benchmark set by CGON and JNJ."
Despite the encouraging comments from analysts, the stock’s decline suggests that investors may have concerns about the small patient sample size and the generalizability of the results. The company is on track to present updated interim data from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025, which may provide further insights into the drug’s efficacy and potential market impact.
Protara’s CEO Jesse Shefferman expressed confidence in the trial’s progress and the potential impact of TARA-002 for patients with NMIBC. The company aims to continue advancing the trial towards its goal of bringing transformative therapies to patients. However, the market’s reaction to the interim results indicates a cautious stance from investors at this stage of the drug’s development.
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