On January 12, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported recent updates and anticipated 2026 milestones.
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"On the heels of a remarkable year marked by meaningful progress across the entirety of our pipeline, we are entering 2026 with unwavering resolve to continue to execute on our mission to deliver transformative therapies to patients with cancer and rare diseases," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "For our non-muscle invasive bladder cancer (NMIBC) program, our growing body of clinical data continue to support that TARA-002 could serve as a differentiated, easy to administer treatment option across the NMIBC treatment landscape. Following our recent ADVANCED-2 update in which TARA-002 demonstrated meaningful and durable activity in BCG-Naïve NMIBC patients, we look forward to providing an interim update on the registrational BCG-Unresponsive trial later this quarter."
Mr. Shefferman added, "We have also made important progress in our rare disease programs. Following positive results from the ongoing Phase 2 STARBORN-1 trial of TARA-002 in lymphatic malformations (LMs), we were pleased that the FDA granted this program both Breakthrough Therapy and Fast Track designations and we expect to provide a regulatory update defining the path to registration in the first half of this year. Additionally, we were pleased to announce that the first patient has been dosed in our registrational THRIVE-3 trial of IV Choline Chloride in patients on long-term parenteral support (PS) and expect to provide an interim analysis in the second half of 2026. We believe we are well positioned for continued success with several key milestones anticipated in the year ahead."
Recent Company Updates and Planned 2026 Milestones
TARA-002 in NMIBC
Protara remains on track to report in the first quarter of 2026 interim results in approximately 25 six-month evaluable patients from its ongoing Phase 2 open-label ADVANCED-2 trial in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive.
In December 2025, the Company reported positive interim results from its ongoing Phase 2 open-label ADVANCED-2 trial in NMIBC patients with CIS (± Ta/T1) who are BCG-Naïve at the 26th Annual Meeting of the Society of Urologic Oncology (SUO) in which TARA-002 demonstrated meaningful response rates at six and 12 months and a favorable safety and tolerability profile. Based on feedback from the U.S. Food and Drug Administration (FDA), the Company plans to commence a registrational trial of TARA-002 compared to intravesical chemotherapy in BCG-naïve patients in the second half of 2026.
Protara continues to evaluate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatments with TARA-002 in NMIBC patients with CIS.
TARA-002 in LMs
Protara recently announced that the FDA granted TARA-002 both Fast Track and Breakthrough Therapy designations for the treatment of pediatric patients with macrocystic and mixed cystic LMs. TARA-002 previously was granted Rare Pediatric Disease designation for the treatment of LMs.
The Company plans to share a regulatory update on the path forward for registration for TARA-002 in LMs in the first half of 2026.
TARA-002 Manufacturing Update
Protara recently announced that TARA-002 has been selected to participate in this year’s FDA Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program. The FDA created the CDRP Program to facilitate CMC development for therapies with compressed clinical development timeframes based on the anticipated clinical benefits of earlier patient access to the therapy. The initiative is designed to promote earlier and more structured engagement between sponsors and FDA on CMC development strategies, and since its inception, has led to increased collaboration with the FDA so sponsors can confidently scale up manufacturing capacity while clinical development is ongoing.
IV Choline Chloride for Patients on PS
The Company recently announced that the first patient has been dosed in THRIVE-3 (NCT06910943), a seamless Phase 2b/3 trial designed to assess the efficacy and safety of low and high dose IV Choline Chloride in adolescent and adult patients receiving long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated. Following an 8-week Phase 2b open-label, dose-confirmation trial in 24 patients, approximately 105 additional patients will be enrolled in a 24-week Phase 3 double-blinded, randomized, placebo-controlled trial. The primary endpoint of the trial is the change in plasma choline concentration from baseline compared to placebo. The Company expects to report interim results in the second half of 2026.
Corporate Update
In December 2025, the Company announced that it closed an underwritten public equity offering of approximately $86 million before deducting underwriting discounts and commissions and offering expenses payable by Protara. The proceeds from the offering are expected to extend the Company’s cash runway into 2028.
(Press release, Protara Therapeutics, JAN 12, 2026, View Source [SID1234661965])