Protara Therapeutics

Protara Therapeutics and CG Oncology presented encouraging Phase II and III data for TARA-002 and cretostimogene grenadenorepvec, respectively, at the Society of Urologic Oncology meeting, showing high complete response rates in non-muscle invasive bladder cancer patients, including those unresponsive to BCG immunotherapy.

TARA-002 shows 72% six-month complete response rate in high-risk NMIBC patients, with 100% CR in BCG-Unresponsive and 64% in BCG-Naïve patients. Favorable safety profile with no Grade 2+ treatment-related adverse events. Protara to host conference call today at 8:30 a.m. ET.

Protara Therapeutics' Phase 2 ADVANCED-2 trial reports 72% complete response rate for TARA-002 in high-risk NMIBC patients at six months, with 100% CR maintenance from three to six months. Two of three patients maintained CR at nine months. TARA-002 showed favorable safety and tolerability with no Grade 2 or greater treatment-related adverse events.

TARA-002 shows promising results in treating high-risk Non-Muscle Invasive Bladder Cancer, with a 72% six-month complete response rate across BCG exposures. BCG-Unresponsive patients achieved a 100% six-month response rate. The therapy demonstrated a favorable safety profile, with no severe treatment-related adverse events. Protara Therapeutics plans to discuss these findings in a conference call and webcast.

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Protara Therapeutics to present interim Phase 2 ADVANCED-2 trial data of TARA-002 in NMIBC at SUO's 25th Annual Meeting, featuring safety and efficacy updates from 20 patients. TARA-002, a cell therapy for NMIBC and LMs, activates immune cells and kills tumor cells, with manufacturing comparable to OK-432.

Protara Therapeutics' Q3 2024 Form 10-Q reports $12.3M in operating expenses, $(12.3M) loss from operations, and $(11.2M) net loss. TARA-002 for NMIBC and LMs shows promising results, with ADVANCED-2 trial data expected in Q4 2024. IV Choline Chloride for parenteral support received FDA Fast Track designation, with THRIVE-3 Phase 3 trial planned for Q1 2025. Protara raised $42M in April 2024, with $81.5M in cash as of September 30, 2024, sufficient for at least 12 months. Challenges include clinical, regulatory, financial, market, operational, and strategic risks.

Protara Therapeutics receives FDA Fast Track designation for IV Choline Chloride, an investigational IV phospholipid substrate replacement therapy for patients on parenteral support. The therapy aims to address choline deficiency, which affects 80% of PS patients, leading to serious health issues. Protara plans to initiate the THRIVE-3 registrational trial in 1Q 2025.

Protara Therapeutics, Inc. (TARA) announced the FDA granted Fast Track designation to Intravenous Choline Chloride, an investigational IV phospholipid substrate replacement therapy for adult and adolescent patients on parenteral support. Protara plans to initiate the registrational THRIVE-3 clinical trial in Q1 2025, assessing safety and efficacy in a Phase 2b/3 trial.