Protara reports Q2 2026 results, redesigns ADVANCED-3 trial for TARA-002

Protara Therapeutics announced second quarter 2026 financial results and a business update on August 11, 2026. The company expects to complete enrollment of the BCG-Unresponsive cohort of its ADVANCED-2 trial in the fourth quarter of 2026.¹

Protara is redesigning the recently initiated ADVANCED-3 trial into a multi-cohort, open-label, exploratory trial to study intravesical TARA-002 in high-grade, high-risk BCG-Naive and BCG-Exposed CIS (with or without Ta/T1) patients and papillary (Ta/T1) patients across BCG exposures, which the company said would accelerate and expand the breadth of TARA-002 data in a broader NMIBC population.¹

In lymphatic malformations, Protara presented updated interim safety and durability data from the Phase 2 STARBORN-1 trial at the International Society for the Study of Vascular Anomalies World Congress, showing clinical success in 83% (10/12) of participants who completed treatment and in 100% (10/10) of evaluable patients as of an April 10, 2026 data cutoff.¹ All seven participants who reached the 32-week post-treatment assessment remained disease free as of the cutoff.¹ Most adverse events were mild to moderate with no serious AEs reported, the most common being swelling and fatigue that were transient.¹ Based on engagement with the FDA under Breakthrough Therapy designation, Protara intends to submit a Biologics License Application for TARA-002 in LMs in the second half of 2027.¹

For IV Choline Chloride, the registrational Phase 3 THRIVE-3 trial is ongoing, with interim results expected in the fourth quarter of 2026.¹

On finances, as of June 30, 2026 unrestricted cash, cash equivalents and marketable debt securities totaled $161.9 million, which the company expects will fund planned operations and milestones into 2028.¹ Protara reported a net loss of $21.7 million, or $0.36 per share, for the quarter, compared with a $15.0 million loss, or $0.35 per share, a year earlier.¹