Protara Therapeutics outlines 2026 milestones for cancer trials

Protara Therapeutics Inc. (NASDAQ: TARA) outlined its clinical development timeline for 2026, including planned interim results from multiple trials across its cancer and rare disease programs.

The company expects to report interim results from approximately 25 six-month evaluable patients in its ADVANCED-2 trial for BCG-unresponsive non-muscle invasive bladder cancer in the first quarter of 2026. The trial is evaluating TARA-002, the company's cell-based therapy, in patients with carcinoma in situ who are unresponsive to Bacillus Calmette-Guérin treatment.

For its lymphatic malformations program, Protara received Breakthrough Therapy and Fast Track designations from the FDA for TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations. The company plans to provide a regulatory update on the registration path in the first half of 2026.

Protara dosed the first patient in its THRIVE-3 registrational trial of IV Choline Chloride for patients dependent on long-term parenteral support. The seamless Phase 2b/3 trial will enroll approximately 129 patients and expects interim results in the second half of 2026.

The company completed an $86 million public offering in December 2025, extending its cash runway into 2028, according to the press release statement.

TARA-002 was selected for the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, designed to facilitate manufacturing development for therapies with compressed clinical timelines.

In December 2025, Protara reported interim results from its ADVANCED-2 trial in BCG-naïve patients, showing response rates at six and 12 months. Based on FDA feedback, the company plans to start a registrational trial comparing TARA-002 to intravesical chemotherapy in BCG-naïve patients in the second half of 2026.

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