Protara Therapeutics to Present Updated, Interim 12-Month Data from the Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients at the American Urological Association Annual Meeting

Protara Therapeutics (Nasdaq: TARA) will present updated interim 12-month data from Cohort A of the Phase 2 ADVANCED-2 trial of TARA-002 in BCG‑naïve NMIBC patients at the AUA Annual Meeting, May 15–18, 2026.

Rhea-AI Summary

Protara Therapeutics (Nasdaq: TARA) will present updated interim 12-month data from Cohort A of the Phase 2 ADVANCED-2 trial of TARA-002 in BCG‑naïve NMIBC patients at the AUA Annual Meeting, May 15–18, 2026.

Data cutoff is April 5, 2026 and includes results from 31 enrolled BCG‑naïve patients. A second poster will encore previously reported BCG‑unresponsive cohort data.

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Key Figures

BCG-Naïve patients: 31 patients AUA 2026 dates: May 15–18, 2026 Induction dosing: Six weekly instillations +5 more

BCG-Naïve patients

31 patients

Enrolled in ADVANCED-2 Cohort A as of April 5, 2026 cutoff

AUA 2026 dates

May 15–18, 2026

American Urological Association Annual Meeting schedule

Induction dosing

Six weekly instillations

Initial intravesical TARA-002 induction course in ADVANCED-2

Maintenance dosing

Three weekly instillations

Maintenance every three months in ADVANCED-2

BCG-Naïve session time

7:00–9:00 a.m.

AUA 2026 poster session for Cohort A on May 15, 2026

BCG-Unresponsive session time

3:30–5:30 p.m.

AUA 2026 encore poster for Cohort B on May 15, 2026

Trial identifier

NCT05951179

ClinicalTrials.gov ID for ADVANCED-2 Phase 2 trial

Publication date

April 27, 2026

Press release announcing AUA presentations

Previous Clinical trial Reports

5 past events · Latest: Jan 22

Same Type 5 events

1. Jan 22

   ADVANCED-2 poster AUA

   24h Move

   +2.4%

   Announcement of updated ADVANCED-2 interim data presentation at ASCO GU meeting.

2. Jan 07

   THRIVE-3 trial start

   24h Move

   +11.1%

   First patient dosed in Phase 3 THRIVE-3 IV Choline Chloride registrational trial.

3. Dec 03

   ADVANCED-2 data update

   24h Move

   +9.3%

   Updated ADVANCED-2 BCG-naïve data with detailed complete response rates and FDA feedback.

4. Nov 19

   STARBORN-1 interim data

   24h Move

   -0.6%

   Positive interim STARBORN-1 results for TARA-002 in pediatric lymphatic malformations.

5. Nov 17

   ADVANCED-2 SUO poster

   24h Move

   +1.1%

   Announcement of ADVANCED-2 BCG-naïve poster at Society of Urologic Oncology meeting.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

phase 2, non-muscle invasive bladder cancer, nmibc, carcinoma in situ, +4 more

8 terms

phase 2 medical

"updated, interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial"

Phase 2 is the mid-stage clinical trial where a new drug or treatment is tested in a larger group of patients to see if it works and to keep checking safety after initial human testing. Think of it as a field test that proves whether a product actually delivers its promised benefit. Investors watch Phase 2 closely because its results strongly influence a medicine’s chances of reaching the market, the size of its potential sales, and the company’s valuation.

non-muscle invasive bladder cancer medical

"TARA-002 in patients with BCG-Naïve non-muscle invasive bladder cancer (NMIBC)"

A form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it like a stain on wallpaper rather than damage to the wall’s studs. It matters to investors because it has different treatment, monitoring and recurrence patterns than deeper cancers, driving demand for repeated outpatient procedures, local therapies and diagnostic tests that affect revenue, trial design and pricing dynamics in healthcare markets.

nmibc medical

"non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session"

A common form of bladder cancer that stays confined to the bladder’s inner lining or the layer just below it and has not grown into the deeper muscle wall. It matters to investors because it often requires repeated procedures, ongoing surveillance and long-term treatments, creating a sizable and stable market for diagnostics, drugs and medical devices; think of it like a surface-level problem that needs frequent check-ups and follow-up care rather than a one-time fix.

carcinoma in situ medical

"ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1)"

Carcinoma in situ is an early-stage abnormal growth where cells look cancerous but remain confined to the tissue surface and have not invaded deeper layers or spread to other parts of the body; think of it like graffiti on a wall that hasn’t cracked the plaster beneath. For investors, it matters because treatments, regulatory pathways, clinical trial outcomes and long-term costs differ greatly between contained lesions and invasive cancer, influencing market value, approval odds and liability for healthcare companies.

bacillus calmette-guérin medical

"who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve."

Bacillus Calmette-Guérin (BCG) is a weakened strain of a bacterium used as a vaccine against tuberculosis and as an immune-stimulating treatment for certain cancers, most notably early-stage bladder cancer. Think of it as a mild coach for the immune system that trains the body to recognize and attack disease; for investors, BCG matters because its supply, regulatory approvals, pricing, or clinical use can affect demand, company revenue, and healthcare costs.

bcg-naïve medical

"data cutoff from 31 enrolled BCG-Naïve patients."

BCG-naïve describes patients who have never received Bacillus Calmette–Guérin (BCG) therapy, a common first-line immunotherapy for certain bladder cancers. For investors, this matters because drugs or devices tested or approved for BCG-naïve patients address a different group and potential market size than treatments for those who already failed BCG; think of it like a product aimed at first-time buyers versus repeat customers.

bcg-unresponsive medical

"BCG-Unresponsive patients that was originally presented at the ASCO Genitourinary Cancers Symposium"

BCG-unresponsive describes a situation in which a patient’s bladder cancer does not shrink or returns despite receiving an adequate course of BCG, a common vaccine-based intravesical treatment used to stimulate the immune system in the bladder. For investors this matters because it defines a group of patients who need alternative therapies or procedures, shaping clinical trial eligibility, regulatory pathways, and the potential market for new drugs; think of it like weeds that resist the usual weed killer and require a different product.

intravesical medical

"an open-label Phase 2 study of intravesical TARA-002 in NMIBC patients"

Intravesical describes a medical treatment or procedure where a drug or therapy is placed directly into the bladder through a catheter rather than taken by mouth or injected into the bloodstream. For investors, it signals a focused delivery method that can increase local effectiveness and reduce whole‑body side effects, often affecting a product’s clinical value, patient convenience, regulatory path, and market niche — like watering a plant at its roots instead of spraying its leaves.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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NEW YORK, April 27, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated, interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial evaluating TARA-002 in patients with BCG-Naïve non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming American Urological Association (AUA) 2026 Annual Meeting taking place from May 15, 2026 to May 18, 2026 in Washington, DC.

The presentation will include data from the abstract published on the AUA website, as well as updated safety and efficacy data as of an April 5, 2026 data cutoff from 31 enrolled BCG-Naïve patients. A second poster presentation will feature previously reported data from the ADVANCED-2 trial cohort of BCG-Unresponsive patients that was originally presented at the ASCO Genitourinary Cancers Symposium in February 2026.

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve. Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

BCG-Naïve Poster Presentation Details:

• Title: ADVANCED-2 (Cohort A): Preliminary Efficacy and Safety Data In BCG-Naïve Participants with High-Grade Non-Muscle Invasive Bladder Cancer
• Session: Bladder Cancer: Non-invasive I
• Presenter: Mark Tyson, M.D., MPH, Vice Chair for Research and a Professor in the Department of Urology with the Mayo Clinic in Phoenix, Arizona
• Session Date and Time: Friday, May 15, 2026, at 7:00 a.m. – 9:00 a.m.

BCG-Unresponsive Encore Poster Presentation Details:

• Title: ADVANCED-2 (Cohort B): Interim Efficacy and Safety Data in BCG-Unresponsive Participants with High-Grade Non-Muscle Invasive Bladder Cancer
• Session: Bladder Cancer: Non-invasive II
• Presenter: Timothy Clinton, M.D., Associate Surgeon with the Brigham and Women’s Hospital in Boston, Massachusetts
• Session Date and Time: Friday, May 15, 2026, at 3:30 p.m. – 5:30 p.m.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Breakthrough and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.

About Protara Therapeutics, Inc.

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.

Company Contact:

Justine O'Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What interim data will Protara (TARA) present at AUA 2026 on May 15, 2026?

Protara will present updated interim 12-month safety and efficacy data from Cohort A of ADVANCED-2. According to Protara Therapeutics, the presentation reflects a data cutoff of April 5, 2026 and includes information from 31 BCG‑naïve enrolled patients.

How many BCG‑naïve patients are included in the TARA-002 ADVANCED-2 Cohort A update?

The Cohort A update includes safety and efficacy data from 31 BCG‑naïve patients. According to Protara Therapeutics, those data are reported as of the April 5, 2026 cutoff and will be shown in the AUA poster session on May 15.

When and where will the Protara ADVANCED-2 BCG‑naïve poster be presented at AUA 2026?

The BCG‑naïve poster is scheduled for Friday, May 15, 2026, 7:00 a.m.–9:00 a.m. in Washington, DC. According to Protara Therapeutics, Mark Tyson, M.D., MPH will present the Cohort A preliminary efficacy and safety data.

What does the ADVANCED-2 trial design for TARA-002 involve for NMIBC patients?

ADVANCED-2 is a Phase 2 open‑label trial of intravesical TARA‑002 for CIS (± Ta/T1) in BCG‑naïve and BCG‑unresponsive patients. According to Protara Therapeutics, treatment is six weekly induction instillations, optional reinduction, then maintenance three weekly instillations every three months.

Will Protara (TARA) also present data from BCG‑unresponsive patients at AUA 2026?

Yes. Protara will present an encore poster showing previously reported interim efficacy and safety data from the BCG‑unresponsive cohort. According to Protara Therapeutics, that encore was originally presented at the ASCO Genitourinary Cancers Symposium in February 2026.