Protara Therapeutics, Inc.
For the period ended May 8, 2025. Filed May 8, 2025.
View on SEC.govAbout this filing
A notice of a major event between regular reports, such as results, a deal or a change of executives. It is often the first formal record of the news.
May 8, 2025 · Filed May 8, 2025
Use the contents to explore the available documents and sections.
TARA$2.30+8.0%Stored close · as of Nov 6, 2026
Contents
EX-99.1 · Recent Progress and Highlights
Recent Progress and Highlights
TARA-002 in NMIBC
| ● | At the American Urological Association (AUA) 2025 Annual Meeting in April, the Company announced positive updated interim results from the ADVANCED-2 trial in evaluable NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive and BCG-Naïve. As of the April 16, 2025 data cutoff: |
| o | TARA-002 demonstrated a complete response (CR) rate at any time of 100% (5/5) and 67% (2/3) at 12 months in the cohort of BCG-Unresponsive patients. As previously communicated, the BCG-Unresponsive cohort is designed to be registrational in alignment with the 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry issued by the U.S. Food and Drug Administration (FDA). |
| o | In the proof-of-concept BCG-Naïve cohort of patients, TARA-002 demonstrated a CR rate at any time of 76% (16/21) and a CR rate of 43% (3/7) at 12 months. |
| o | The majority of adverse events were Grade 1 and transient, with no Grade 3 or greater treatment-related adverse events as assessed by study investigators. |
| ● | Interim results from approximately 25 six-month evaluable BCG-Unresponsive patients are expected to be announced by the end of 2025. |
| ● | Following regulatory alignment with the FDA, the Company expects to provide an update on the design of its planned BCG-Naïve registrational trial in the second half of 2025. |
| ● | Protara continues to investigate subcutaneous dosing through priming and maintenance combined with intravesical dosing, as well as exploring combination treatment with TARA-002 in NMIBC patients with CIS. |
IV Choline Chloride for Patients on Parenteral Support (PS)
| ● | The Company plans to initiate THRIVE-3, a registrational Phase 3 clinical trial, in the third quarter of 2025. THRIVE-3 is a seamless Phase 2b/3 trial with a dose confirmation portion (n=24) followed by a double-blinded, randomized, placebo-controlled portion to assess the efficacy and safety of IV Choline Chloride over 24 weeks in adolescents and adults on long-term PS when oral or enteral nutrition is not possible, insufficient, or contraindicated (n=105). IV Choline Chloride was previously granted Fast Track designation by the FDA. |
TARA-002 in LMs
| ● | Dosing continues to progress in the Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic LMs and the Company intends to provide an interim update from the trial in the second half of 2025. The Company previously announced the completion of the study’s first safety cohort, in which TARA-002 showed promising results and was generally well-tolerated. |
Corporate Update
| ● | In April 2025, Protara strengthened its leadership team with the appointments of Leonardo Viana Nicacio, M.D., as Chief Medical Officer, and Shane Williams, Ph.D., as Vice President, Head of Human Resources, Chief People Officer. Dr. Nicacio brings to Protara nearly 20 years of broad oncology, drug development, regulatory and commercial experience across leading biopharmaceutical and health technology companies, and most recently served as Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics. Dr. Williams brings a strong track record of driving growth, leading transformational change, and building high-performing teams across innovative life science organizations. He most recently served as Chief People Officer at Century Therapeutics. |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.