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Protara Therapeutics Strengthens TARA-002 Development Progress
"In the second quarter, we strengthened our late-stage pipeline through continued operational execution, positioning us for multiple important milestones over the coming quarters," said Jesse Shefferman, Chief Executive Officer at Protara Therapeutics. "We continue to make progress in the ADVANCED-2 trial and expect to complete enrollment in the fourth quarter of 2026. We remain confident that TARA-002 will be a preferred treatment option in the non-muscle invasive bladder cancer (NMIBC) BCG-Unresponsive setting, and we are redesigning ADVANCED-3 to be a multi-cohort, open-label, exploratory trial, which will allow us to study TARA-002 in a broader high-grade, high-risk NMIBC patient population. The redesigned ADVANCED-3 protocol is expected to accelerate and expand the breadth of data available at or around the time of the potential launch of TARA-002 in BCG-Unresponsive carcinoma in situ patients."
Protara Updates TARA-002 Clinical Data
Protara Therapeutics announced updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS non-muscle invasive bladder cancer. These results in Bacillus Calmette-Guerin-Naive NMIBC patients will be featured today during a poster session at the American Urological Association annual meeting in Washington, D.C. The BCG-Naive dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5 data cutoff. The CR rate at any time in BCG-Naive patients was 72.4%. The CR rate in BCG-Naive patients was 66.7% at six months and 55% at 12 months. The Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1%. Overall, 91.7% maintained their CR from nine to 12 months. Overall, 66.7% of re-induced patients converted to a CR at six months. The majority of treatment-related adverse events were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria.
Protara Therapeutics Files $300M Mixed Securities Shelf
Protara Therapeutics files $300M mixed securities shelf
Protara Therapeutics to Submit BLA for TARA-002 in 2027
"We're pleased with the productive discussions we've had with the FDA around TARA-002 in LMs," said Jesse Shefferman, CEO of Protara Therapeutics. "We intend to submit a BLA for TARA-002 in LMs based on the results of the pivotal STARBORN-1 trial in the second half of 2027. Later this month, we look forward to presenting updated safety and durability data from the STARBORN-1 trial at the ISSVA World Congress and hosting an investor webinar with KOL perspectives."
Jesse Shefferman: TARA-002 Progressing Well, Key Milestones Expected in 2026
"Over the last few months, we reported meaningful clinical and regulatory progress across our portfolio of late-stage programs and are building on this momentum as we advance toward several important milestones in 2026," said Jesse Shefferman, CEO. "For TARA-002 in non-muscle invasive bladder cancer, the clinical dataset continues to support its potential as a differentiated intravesical therapy with compelling efficacy, a favorable safety profile and a streamlined approach to administration in the clinical setting for both Bacillus Calmette-Guerin-Unresponsive and BCG-Naive patients. We remain on track to complete enrollment in our BCG-Unresponsive registrational cohort in the ADVANCED-2 trial and to initiate the ADVANCED-3 registrational trial in BCG-Naive patients in the second half of 2026. For our rare disease programs, we reported positive interim results for TARA-002 in lymphatic malformations, followed by the receipt of Breakthrough Therapy and Fast Track designations for TARA-002 in LMs from the U.S. Food and Drug Administration. We are working with the FDA to bring this promising treatment to patients expeditiously and expect to provide a regulatory update in the first half of 2026. In addition, our THRIVE-3 registrational trial of intravenous Choline Chloride for patients on parenteral support remains on track, with interim results expected in the second half of 2026. With cash runway into 2028, we are well positioned to continue executing across our pipeline and advance our mission of delivering transformational therapies for patients with cancer and rare diseases."
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