Protara Therapeutics Highlights Recent Updates and Anticipated 2026 Milestones

Overview of Recent Achievements and Upcoming Milestones

Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology firm focused on developing innovative therapies for cancer and rare diseases, has made significant strides in its clinical programs while outlining key milestones expected in 2026. The company has recently reported its progress in several ongoing trials, including TARA-002's role in treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs).

“Entering 2026, we remain dedicated to our mission of delivering transformative therapies to patients suffering from cancer and rare diseases,” stated Jesse Shefferman, CEO of Protara Therapeutics. He emphasized the promising data surrounding TARA-002 as a potential treatment option across the NMIBC landscape.

Key Updates on TARA-002 and Clinical Trials

Progress in NMIBC Trials

Protara is on track to release interim results in Q1 2026 from around 25 patients in its ADVANCED-2 trial aimed at BCG-Unresponsive NMIBC patients. The company reported promising interim findings at the 26th Annual Meeting of the Society of Urologic Oncology, indicating that TARA-002 exhibited meaningful response rates and a commendable safety profile.

FDA Designations for TARA-002 in LMs

Following encouraging results from the Phase 2 STARBORN-1 trial, TARA-002 has received both Breakthrough Therapy and Fast Track designations from the FDA for treating pediatric patients with lymphatic malformations. Protara will provide a regulatory update on the path towards registration in the first half of 2026.

Clinical Trials and Manufacturing Advancements

Updates on the THRIVE-3 Trial

Protara has initiated the THRIVE-3 trial, dosing the first patient in this Phase 2b/3 trial investigating the effectiveness of IV Choline Chloride for patients on long-term parenteral support. The trial involves a planned enrollment of approximately 105 patients and is expected to yield interim results in the second half of 2026.

Manufacturing Developments for TARA-002

TARA-002 has also been accepted into the FDA's Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, aimed at enhancing collaboration between the FDA and sponsors to support the therapy's expedited development and production processes.

Corporate Financial Update

In December 2025, Protara closed a public equity offering totaling approximately $86 million, which will extend its financial runway into 2028. This capital is crucial for fueling the ongoing development of its promising therapies, including TARA-002.

About Protara Therapeutics, Inc.

Protara Therapeutics is a dedicated biotechnology firm advancing innovative therapies for individuals diagnosed with cancer and rare diseases. Its lead candidate, TARA-002, is currently under evaluation for the treatment of NMIBC and lymphatic malformations. Additionally, the company is working on IV Choline Chloride to meet the nutritional needs of patients unable to rely on oral or enteral routes.