Protara Therapeutics (TARA) Company Report

Protara Therapeutics (TARA) discussed its two main assets, TARA-002 and IV Choline Chloride, at Oppenheimer's 36th Annual Healthcare Life Sciences Conference on February 26, 2026.
For TARA-002 in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), the ADVANCED-2 study showed a 68% complete response rate at 6 months (22 patients) and a 33% preliminary complete response rate at 12 months (15 evaluable patients).
Protara is also developing TARA-002 for frontline NMIBC (ADVANCED-3 study), targeting an estimated 11,000-15,000 patients annually who are BCG-eligible but do not receive it, with potential for an additional tens of thousands in the BCG-exposed population. The FDA is allowing a chemo comparator for ADVANCED-3 instead of a head-to-head with BCG.
The company is advancing TARA-002 for lymphatic malformations (LMs) and is working towards an FDA engagement to define a registrational path, with an estimated market opportunity of 1,000-1,200 patients per year.
Protara's IV Choline Chloride program addresses choline deficiency in approximately 35,000 patients on long-term chronic parenteral nutrition in the US, with an Orange Book listed patent extending to 2041.

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Transcript

Protara Therapeutics Provides Update on TARA-002 and IV Choline Chloride Development

TARA

New Projects/Investments

Guidance Update

Protara Therapeutics (TARA) is advancing TARA-002, a cell-based immunopotentiator, for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LM).
Recent interim data from the ADVANCED-2 study in BCG-unresponsive NMIBC showed a 68% complete response rate at 6 months (n=22) and a 33% preliminary CR rate at 12 months (n=15). The company is also developing TARA-002 for front-line NMIBC, addressing an unmet need of 11,000-15,000 patients annually.
For LM, Protara is preparing for an FDA engagement to define a registrational path for TARA-002, with a potential market of 1,000-1,200 patients per year. The company also noted the renewal of its PRV program, with a recent voucher sale posted at $205 million.
The company is also developing IV Choline Chloride for choline deficiency in patients on long-term parenteral nutrition, a condition affecting approximately 35,000 patients in the U.S., and holds a product claim patent until 2041.

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Protara Therapeutics Provides Updates on TARA-002 NMIBC and LM Programs, and IV Choline Chloride Development

TARA

New Projects/Investments

Product Launch

Protara Therapeutics (TARA) reported updated interim data for TARA-002 in the ADVANCED-2 study for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), showing a 68% complete response rate at six months (out of 22 patients) and a preliminary 33% CR rate at 12 months (out of 15 evaluable patients).
The company is initiating the ADVANCED-3 study for TARA-002 in frontline NMIBC, targeting an unmet need of 11,000 to 15,000 patients annually who are eligible for but do not receive BCG, with ADVANCED-2 expected to be fully enrolled by the end of 2026.
For lymphatic malformations (LM), Protara is working towards an FDA engagement to define a registrational path for TARA-002, with an estimated market of 1,000-1,200 patients per year and a renewed Priority Review Voucher (PRV) program.
Protara's IV Choline Chloride program targets an estimated 35,000 patients in the U.S. on long-term parenteral nutrition, with 80% of these patients being choline deficient and 68% experiencing liver injury; the product has patent protection until 2041.

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Protara Therapeutics Announces Positive Interim Results for TARA-002 in Bladder Cancer Trial

TARA

New Projects/Investments

Guidance Update

Protara Therapeutics announced updated interim results from its Phase 2 ADVANCED-2 trial for TARA-002 in Non-Muscle Invasive Bladder Cancer (NMIBC) as of a January 28, 2026 data cutoff.
In the BCG-Unresponsive cohort, TARA-002 demonstrated a complete response (CR) rate of 68.2% at six months and 33.3% at 12 months.
For the BCG-Naïve cohort, the CR rate was 66.7% at six months and 57.9% at 12 months.
The trial showed a favorable safety and tolerability profile for TARA-002, with no Grade 3 or greater treatment-related adverse events.
The company anticipates completing enrollment for the BCG-Unresponsive cohort of ADVANCED-2 and initiating the ADVANCED-3 registrational trial for BCG-Naïve patients in the second half of 2026.

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8-K

Protara Therapeutics Provides ASCO GU Update on TARA-002 ADVANCED-2 Trial Results

TARA

New Projects/Investments

Guidance Update

Protara Therapeutics announced positive interim results from its phase II ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) on February 24, 2026.
In the BCG-unresponsive cohort, TARA-002 achieved a complete response (CR) rate of 68% at six months and 33% at 12 months, with management anticipating the 12-month CR rate to reach the 40s as data matures.
For the BCG-naïve cohort, the CR rate was 67% at six months and 58% at 12 months, demonstrating good durability with a 73% Kaplan-Meier estimated probability of maintaining a CR for six months.
TARA-002 exhibited a favorable safety profile, with mostly mild, transient adverse events and no treatment-related discontinuations.
Protara expects to complete enrollment in the BCG-unresponsive cohort in the second half of 2026 and plans to initiate the ADVANCED-3 registrational trial in BCG-naïve patients later this year.

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Transcript

Protara Therapeutics Reports Positive Interim Results from ADVANCED-2 Trial for TARA-002

TARA

New Projects/Investments

Protara Therapeutics announced positive interim results from its ongoing phase II ADVANCED-2 trial of TARA-002 in non-muscle invasive bladder cancer (NMIBC), with a data cutoff of January 2026.
In the BCG-unresponsive cohort, TARA-002 demonstrated a 6-month complete response rate of 68% and a 12-month complete response rate of 33%. The company anticipates the 12-month CR rate will reach the 40s as the data set fully matures.
The BCG-naïve cohort showed a 6-month complete response rate of 67% and a 12-month complete response rate of 58%. Both cohorts exhibited high reinduction success rates, with 62% (BCG-unresponsive) and 67% (BCG-naïve) of reinduced patients converting to complete response at 6 months.
TARA-002 has a favorable safety profile, with mostly mild, self-limited local reactions and no related serious adverse events or treatment-related discontinuations. Its off-the-shelf availability and simple office-based administration are highlighted as significant competitive advantages.

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Transcript

Protara Therapeutics Presents Interim Data for TARA-002 in NMIBC

TARA

Product Launch

New Projects/Investments

Protara Therapeutics presented interim data from the ADVANCED-2 trial of TARA-002 for Non-Muscle Invasive Bladder Cancer (NMIBC) at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium in February 2026.
TARA-002 demonstrated significant complete response rates: 68% at 6 months and 33% at 12 months in BCG-Unresponsive NMIBC patients, and 67% at 6 months and 58% at 12 months in BCG-Naïve NMIBC patients.
The drug exhibited a favorable safety and tolerability profile, with no Grade 3 or greater treatment-related adverse events (TRAEs) observed across all BCG exposures.
The company expects to complete enrollment in the BCG-Unresponsive registrational cohort of ADVANCED-2 in 2H'26 and initiate enrollment in the BCG-Naïve NMIBC ADVANCED-3 registrational trial in 2H'26.

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Presentation

Protara Therapeutics Reports Positive Interim Results from TARA-002 Phase 2 ADVANCED-2 Trial

TARA

New Projects/Investments

Guidance Update

Protara Therapeutics announced positive interim results from its Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) in both BCG-unresponsive and BCG-naïve cohorts.
In the BCG-unresponsive cohort, TARA-002 achieved a 68% complete response rate at 6 months and a 33% complete response rate at 12 months, with the company anticipating the 12-month rate to reach the 40s as data matures.
The BCG-naïve cohort demonstrated a 67% complete response rate at 6 months and a 58% complete response rate at 12 months.
TARA-002 showed excellent safety and tolerability, with mostly mild, self-limited local reactions and no serious adverse events or treatment discontinuations due to adverse events.
Protara expects to complete enrollment in the BCG-unresponsive cohort in the second half of 2026 and plans to start the ADVANCED-3 registrational trial for BCG-naïve patients later this year.

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Transcript

Protara Therapeutics Reports Positive Interim Results for TARA-002 in ADVANCED-2 Trial

TARA

New Projects/Investments

Guidance Update

Protara Therapeutics announced positive interim results from its ongoing Phase II ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC), with a data cutoff of January 2026.
In the BCG-unresponsive cohort, TARA-002 demonstrated a 6-month complete response rate of 68% and a 12-month complete response rate of 33%, with the company anticipating the 12-month rate to reach the 40s as the data set matures.
For the BCG-naïve cohort, TARA-002 showed a 6-month complete response rate of 67% and a 12-month complete response rate of 58%.
TARA-002 exhibited a favorable safety and tolerability profile, with the majority of treatment-related adverse events being mild and transient, and no participants discontinuing treatment due to related adverse events.
The company expects to complete enrollment in the BCG-unresponsive cohort in the second half of 2026 and plans to initiate the ADVANCED-3 registrational trial for BCG-naïve patients later in 2026.

4 days ago

Transcript

Protara Therapeutics Announces Positive Interim Phase 2 ADVANCED-2 Trial Results for TARA-002

TARA

Protara Therapeutics announced positive interim results from its Phase 2 ADVANCED-2 trial of TARA-002 in patients with NMIBC, with a data cutoff of January 2026.
In the BCG-unresponsive cohort, TARA-002 achieved a 6-month complete response rate of 68% and a 12-month complete response rate of 33%. Enrollment for this registrational study is anticipated to conclude in the second half of 2026.
For the BCG-naïve cohort, complete response rates were 67% at 6 months and 58% at 12 months, with this cohort being fully enrolled.
TARA-002 demonstrated excellent safety and tolerability, with the majority of treatment-related adverse events being grade 1 and transient, and no related serious adverse events or treatment-related discontinuations.
The company highlights TARA-002's potential best-in-class product profile due to its efficacy, durability, favorable safety, off-the-shelf availability, and simple administration, which is particularly relevant given that approximately 80% of NMIBC patients are treated in community settings.