Protara reports Q3 2026 results, updates timelines for TARA-002 and IV Choline Chloride
The company said it expects to finish enrolling a key NMIBC cohort by year-end and pushed back its lymphatic malformation enrollment completion to early 2027, with cash seen lasting into 2028.
Protara Therapeutics reported third quarter 2026 results on November 6, 2026 and gave updates across its three clinical programs.
For TARA-002 in non-muscle invasive bladder cancer, the company said it expects to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in the fourth quarter of 2026.1 Separately, during the third quarter of 2026 the company announced plans to redesign the ongoing ADVANCED-3 trial into a multi-cohort, open-label study evaluating intravesical TARA-002 in BCG-Naïve and BCG-Exposed CIS and high-grade, high-risk papillary patients across BCG exposures, intended to generate a broad body of clinical evidence.1
For TARA-002 in lymphatic malformations, Protara said enrollment in the registrational "STARBORN-1" trial is now expected to complete early in the first quarter of 2027, a shift from prior guidance. Citing engagement with the FDA under the program's Breakthrough Therapy designation, the company said it still expects to begin a rolling Biologics License Application submission for TARA-002 in lymphatic malformations in the second half of 2027.1
On IV Choline Chloride, Protara completed enrollment of the Phase 2b portion of its registrational Phase 2b/3 "THRIVE-3" trial, an open-label dose confirmation study in adolescent and adult patients with intestinal failure who depend on parenteral support and have choline deficiency, enrolling 24 patients.1 The company said it remains on track to report interim results from that Phase 2b portion in the fourth quarter of 2026.1
On the corporate side, on November 4, 2026 Protara entered an asset purchase agreement with Novex Innovations, LLC, which has manufactured TARA-002 for Protara since 2019 under a Manufacturing Services Agreement, for TARA-002 manufacturing-related assets at an aggregate price of $8.75 million, to bring manufacturing in-house ahead of a potential commercial launch.1
Financially, as of September 30, 2026 Protara held $143.1 million in unrestricted cash, cash equivalents and marketable debt securities, which it said should fund planned operations and milestones into 2028.1 Net loss for the quarter was $21.7 million, or $0.35 per share, compared with $13.3 million, or $0.31 per share, in the prior-year period.1
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