Protara Therapeutics, Inc.

Protara Therapeutics Completes Enrollment of the Phase 2b Open-Label Dose Confirmation Phase of the THRIVE-3 Registrational Trial of IV Choline Chloride in Patients on Parenteral Support

Protara Therapeutics completed enrollment of the Phase 2b open-label dose confirmation portion of the registrational THRIVE-3 trial of IV Choline Chloride in intestinal failure patients dependent on parenteral support. The Phase 2b cohort includes 24 patients, with interim results from the dosing cohort on track to be reported in the fourth quarter of 2026; the Phase 3 portion will enroll roughly 100 patients with plasma choline elevation as the primary endpoint. IV Choline Chloride holds Orphan Drug and Fast Track designations and could become the first FDA-approved IV choline formulation for the roughly 30,000 long-term PS patients in the U.S., about 80% of whom have choline deficiency.

•17d ago

Protara Therapeutics Announces Second Quarter 2026 Financial Results and Provides a Business Update

Protara reported $161.9 million in cash, cash equivalents and investments, expected to fund planned operations into 2028, alongside progress across its late-stage pipeline. Interim data from the STARBORN-1 trial demonstrated an 83% clinical success rate for TARA-002 in Lymphatic Malformations, with a BLA submission planned for the second half of 2027. For the second quarter, the company recorded a net loss of $21.7 million, or $0.36 per share, driven primarily by increased clinical trial costs and personnel expenses.

•2mo ago

Protara Therapeutics Announces Positive Updated 12-Month Data Demonstrating Durable Responses in the Fully Enrolled BCG-Naïve Cohort of the Ongoing Phase 2 ADVANCED-2 Trial of TARA-002 in NMIBC

Protara Therapeutics reported positive 12-month data from the Phase 2 ADVANCED-2 trial of TARA-002 in BCG-Naïve NMIBC patients. The data showed a 55% complete response rate at the 12-month landmark, with 91.7% of responders maintaining their response from nine to 12 months. The safety profile was favorable with no Grade 3 or greater treatment-related adverse events, supporting the plan to initiate the registrational ADVANCED-3 trial in 2H 2026.

•5mo ago

Protara Therapeutics Announces First Quarter 2026 Financial Results and Provides a Business Update

Protara confirmed its intent to submit a BLA for TARA-002 in Lymphatic Malformations in the second half of 2027, supported by Breakthrough Therapy designation and ongoing FDA dialogue. The company reported $177.4 million in cash and investments, sufficient to fund operations into 2028, while enrolling patients for the ADVANCED-2 and initiating the ADVANCED-3 trials in the second half of 2026. Q1 financial results showed a net loss of $17.8 million, or $0.31 per share, driven by increased R&D spending related to clinical trial activities.

•5mo ago