Earnings summaries and quarterly performance for Protara Therapeutics.
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Recent press releases and 8-K filings for TARA.
Protara Therapeutics Provides Updates on Late-Stage Clinical Programs
TARA
New Projects/Investments
Guidance Update
Product Launch
- Protara Therapeutics, a clinical-stage biotechnology company, has multiple late-stage development programs in oncology and rare diseases.
- In non-muscle invasive bladder cancer (NMIBC), a data release is anticipated in February 2026 for 25 six-month evaluable patients in the BCG-unresponsive ADVANCED-2 study. The company also secured FDA agreement for a randomized controlled study in BCG-naive patients, representing a significantly larger market opportunity.
- The lymphatic malformations program (TARA-002) has achieved Breakthrough Therapy and Fast-Track Designations from the FDA, with clarity on the regulatory path to registration expected by the end of Q2 2026. This program has shown 100% clinical success rates in evaluable patients at the eight-week time point.
- The IV Choline Chloride program has initiated its pivotal Phase III study, with an interim data update on the primary endpoint expected in mid-2026.
- Protara projects initial FDA approvals for its programs starting in 2027, with further approvals anticipated annually through 2030.
6 days ago
Protara Therapeutics Updates on Clinical Pipeline and Regulatory Milestones at J.P. Morgan Healthcare Conference
TARA
New Projects/Investments
Guidance Update
Product Launch
- Protara Therapeutics provided an update on its non-muscle invasive bladder cancer (NMIBC) program (TAR 002), anticipating a data release in February 2026 for the ADVANCED-2 study (BCG-unresponsive patients) with expected complete response rates of 72% at six months and 50% at 12 months. The company also has an FDA-agreed randomized controlled study for BCG-naive patients, targeting a patient population five times larger than the BCG-unresponsive group.
- The lymphatic malformations program (TAR 002) has received breakthrough therapy and fast-track designations. Recent data showed 80% clinical success across all patients, with 100% clinical success in evaluable patients at eight weeks. Clarity on the regulatory path is expected by the end of Q2 2026, with a US market opportunity estimated at 1,400-1,800 live births per year.
- The IV Choline Chloride program is in a seamless Phase 2B/3 pivotal study, with interim data on the primary endpoint (choline serum elevations) expected in mid-2026 for the first 24 patients, and secondary clinical endpoints anticipated towards the end of 2026. This program targets approximately 40,000 patients in the US.
- Protara Therapeutics has multiple programs in late-stage development and anticipates receiving FDA approvals starting in 2027, with subsequent approvals projected for 2028, 2029, and 2030.
6 days ago
Protara Therapeutics Highlights 2026 Milestones and Financial Update
TARA
Guidance Update
New Projects/Investments
- Protara Therapeutics extended its cash runway into 2028 following an approximately $86 million public offering completed in December 2025.
- The company anticipates reporting interim results in Q1 2026 from the ADVANCED-2 trial for TARA-002 in BCG-Unresponsive NMIBC patients.
- TARA-002 received Breakthrough Therapy and Fast Track designations for lymphatic malformations (LMs), with a regulatory update on the path to registration expected in 1H 2026.
- The first patient was dosed in the THRIVE-3 registrational trial for IV Choline Chloride, with interim results expected in 2H 2026.
Jan 12, 2026, 12:00 PM
Protara Therapeutics Initiates Patient Dosing in Phase 3 THRIVE-3 Trial for IV Choline Chloride
TARA
New Projects/Investments
- Protara Therapeutics (Nasdaq: TARA) has commenced patient dosing in its Phase 3 registrational THRIVE-3 clinical trial for intravenous (IV) Choline Chloride.
- The trial evaluates IV Choline Chloride as a phospholipid substrate replacement therapy for patients receiving long-term parenteral support (PS), a condition where 78% of patients are choline-deficient with no currently approved IV choline products.
- IV Choline Chloride has been granted Fast Track and Orphan Drug Designations by the U.S. Food and Drug Administration (FDA).
- Protara Therapeutics anticipates providing an interim analysis from the THRIVE-3 trial in the second half of 2026.
Jan 7, 2026, 1:00 PM
Protara Therapeutics' TARA-002 Receives FDA Breakthrough Therapy and Fast Track Designations for Lymphatic Malformations
TARA
New Projects/Investments
- Protara Therapeutics' investigational cell-based therapy, TARA-002, has been granted Breakthrough Therapy and Fast Track designations by the FDA for the treatment of pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).
- The FDA also selected TARA-002 to participate in the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program, which aims to support CMC development for products with expedited clinical development timeframes.
- These designations and program participation highlight the significant unmet need for LM treatments and underscore Protara's belief in TARA-002's potential as a meaningful treatment option for this underserved patient population.
- Protara Therapeutics anticipates meeting with the FDA in the first half of 2026 to define the path to registration for TARA-002 in LMs.
Jan 5, 2026, 1:00 PM
Protara Therapeutics Announces Common Stock Offering
TARA
New Projects/Investments
- Protara Therapeutics, Inc. entered into an Underwriting Agreement on December 4, 2025, to sell 13,043,479 shares of common stock.
- The public offering price was $5.75 per share, with expected aggregate gross proceeds of approximately $75 million from the offering, which closed on December 8, 2025.
- The net proceeds are intended to fund the clinical development of TARA-002, as well as other clinical programs, working capital, and general corporate purposes.
- The company, its officers, and directors have entered into 60-day lock-up agreements following the date of the Underwriting Agreement.
Dec 8, 2025, 9:15 PM
Protara Therapeutics Closes Public Offering
TARA
New Projects/Investments
- Protara Therapeutics announced the closing of its underwritten public offering on December 8, 2025.
- The offering involved the issuance of 13,043,479 shares of common stock at a public offering price of $5.75 per share.
- The gross proceeds from the offering totaled approximately $75 million.
- Protara intends to use the net proceeds to fund the clinical development of TARA-002, other clinical programs, working capital, and general corporate purposes.
Dec 8, 2025, 9:05 PM
Protara Prices $75 Million Public Offering
TARA
New Projects/Investments
- Protara Therapeutics announced the pricing of an underwritten public offering of 13,043,479 shares of its common stock at a price of $5.75 per share.
- The offering is expected to generate approximately $75 million in gross proceeds before deducting underwriting discounts and commissions.
- Protara intends to use the net proceeds to fund the clinical development of TARA-002, as well as other clinical programs, working capital, and general corporate purposes.
- The offering is expected to close on December 8, 2025.
Dec 5, 2025, 3:03 AM
Protara Therapeutics Provides TARA-002 Clinical and Regulatory Updates
TARA
New Projects/Investments
Guidance Update
- Protara Therapeutics reported updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 in BCG-Naïve Non-Muscle Invasive Bladder Cancer (NMIBC) patients, demonstrating a 72% complete response (CR) rate at any time, a 69% 6-month landmark CR rate, and a 50% 12-month landmark CR rate. The trial also showed a favorable safety and tolerability profile with no Grade 3 or greater treatment-related adverse events (TRAEs).
- The registrational BCG-Unresponsive cohort for TARA-002 is progressing, with interim results from approximately 25 six-month evaluable patients expected in Q1 2026 and full enrollment anticipated in 2H 2026.
- For Lymphatic Malformations (LMs), regulatory feedback for TARA-002 is expected in 1H 2026, and full enrollment for the STARBORN-1 trial is also expected in 2H 2026.
Dec 3, 2025, 1:30 PM
Protara Therapeutics Reports Positive TARA-002 Data in BCG-Naive NMIBC Patients
TARA
New Projects/Investments
- Protara Therapeutics announced updated positive results for TARA-002 in BCG-naive non-muscle invasive bladder cancer (NMIBC) patients from its ADVANCED-2 trial, with a data cutoff of November 7, 2025.
- The trial demonstrated compelling efficacy, with a complete response (CR) rate of 72% at any time, 69% at six months, and 50% at 12 months in 31 BCG-naive patients. These rates are significantly higher than benchmarks for current chemotherapies like Gemcitabine (40% CR at six months, 15% at 12 months) and Mitomycin (35% CR at six months).
- TARA-002 exhibited a favorable safety and tolerability profile, with no grade 3 or higher treatment-related adverse events, no discontinuations due to AEs, and no treatment-related serious adverse events.
- The company expects full enrollment of the BCG unresponsive cohort in ADVANCED-2 in the second half of 2026 and plans to report interim results in the first quarter of 2026 from at least 25 patients in this cohort.
- TARA-002 is positioned as a potential best-in-class treatment, offering a significant alternative in the NMIBC landscape, particularly amidst BCG shortages, due to its efficacy, safety, and ease of administration.
Dec 3, 2025, 1:30 PM
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