Protara Therapeutics to Present Updated Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Unresponsive NMIBC Patients at the ASCO Genitourinary Cancers Symposium

Rhea-AI Summary

Protara Therapeutics (NASDAQ: TARA) will present updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 at the ASCO Genitourinary Cancers Symposium in San Francisco, Feb 26–28, 2026.

The poster will report safety and efficacy from approximately 25 six-month evaluable BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients in Cohort B. ADVANCED-2 (NCT05951179) is an open-label Phase 2 study of intravesical TARA-002 with Cohort B (BCG-unresponsive, N=75–100) and Cohort A (BCG-naïve, N=31). Dosing: six weekly induction instillations (with optional reinduction) followed by three weekly maintenance instillations every three months.

Poster details: F15 (interim efficacy/safety in BCG-unresponsive) and H8 (interim safety/tolerability across cohorts), both scheduled for Poster Session B on Friday, Feb 27, 2026.

News Market Reaction

+2.43%

1 alert

+2.43% News Effect

On the day this news was published, TARA gained 2.43%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Six-month evaluable patients: approximately 25 patients Cohort B size: N=75-100 Cohort A size: N=31 +5 more

8 metrics

Six-month evaluable patients approximately 25 patients BCG-unresponsive NMIBC cohort in Phase 2 ADVANCED-2

Cohort B size N=75-100 BCG-unresponsive NMIBC patients in ADVANCED-2

Cohort A size N=31 BCG-naïve NMIBC patients in ADVANCED-2

Induction regimen six weekly intravesical instillations TARA-002 induction course in ADVANCED-2

Maintenance regimen three weekly instillations every three months TARA-002 maintenance in ADVANCED-2

ASCO GU dates February 26–28, 2026 ASCO Genitourinary Cancers Symposium in San Francisco

Poster date Friday, February 27, 2026 Poster Session B: Prostate Cancer and Urothelial Carcinoma

Poster numbers F15 and H8 ADVANCED-2 efficacy/safety and tolerability presentations

Market Reality Check

Price: $6.19 Vol: Volume 1,634,810 is 1.72x...

high vol

$6.19 Last Close

Volume Volume 1,634,810 is 1.72x the 20-day average of 950,690, indicating elevated pre-news activity. high

Technical Shares at $5.77 are trading above the 200-day MA of $4.17 and below the 52-week high of $7.82.

Peers on Argus

TARA is up 3.04% while key biotech peers are mixed: BMEA up 0.71%, but EQ, IKT, ...

2 Up

TARA is up 3.04% while key biotech peers are mixed: BMEA up 0.71%, but EQ, IKT, IOBT, and KALA show declines, suggesting a stock-specific reaction to the trial update news rather than a broad sector move.

Historical Context

5 past events · Latest: Jan 12 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 12	2026 milestones outlook	Positive	-8.9%	Outlined 2026 clinical milestones and cash runway extension after offering.
Jan 07	Conference presentation	Neutral	+11.1%	Announced J.P. Morgan Healthcare Conference presentation and webcast details.
Jan 07	Phase 3 trial start	Positive	+11.1%	Dosed first patient in Phase 3 THRIVE-3 IV Choline Chloride trial.
Jan 05	FDA designations	Positive	+0.2%	Received FDA Breakthrough and Fast Track designations for TARA-002 in pediatric LMs.
Dec 08	Equity offering	Negative	+0.3%	Closed $75M public offering to fund TARA-002 and other programs.

Pattern Detected

Clinical and milestone updates have often produced positive moves, while financing and dense milestone rundowns have sometimes seen negative or muted reactions.

Recent Company History

Over recent months, Protara has reported multiple key developments. On Dec 8, 2025, it closed a $75 million public offering at $5.75 per share, later expanded to ~$86.3 million via option exercise. Subsequent news highlighted FDA Breakthrough and Fast Track designations for TARA-002, initiation of the Phase 3 THRIVE-3 trial, and a 2026 milestones overview. Earlier clinical updates for TARA-002 in NMIBC and lymphatic malformations have shown strong responses and generally positive price reactions, framing today’s ADVANCED-2 update as part of an ongoing clinical data build-out.

Market Pulse Summary

This announcement details upcoming presentations of updated safety and efficacy data from the Phase ...

Analysis

This announcement details upcoming presentations of updated safety and efficacy data from the Phase 2 ADVANCED-2 trial of TARA-002 in BCG-unresponsive and BCG-naïve NMIBC at the ASCO GU 2026 symposium. It follows recent positive interim data in related cohorts and other TARA-002 programs, plus the start of the Phase 3 THRIVE-3 trial. Investors may focus on response durability, safety profile across cohorts, and how new findings compare with prior NMIBC and lymphatic malformation data.

Key Terms

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

8 terms

phase 2 medical

"ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing..."

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

"BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients..."

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) patients in the ongoing Phase 2..."

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

"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.

cis medical

"with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin..."

Cis is a descriptor from chemistry meaning two parts of a molecule sit on the same side of a bond or ring, like two passengers sitting on the same side of a seesaw. That arrangement can change a drug’s shape, how it behaves in the body, and whether regulators approve it or competitors can patent it. Investors watch “cis” versus “trans” forms because those small structural differences can affect safety, effectiveness, manufacturing and commercial value.

bacillus calmette-guérin medical

"who are Bacillus Calmette-Guérin (BCG)-Unresponsive (Cohort B N=75-100)..."

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.

intravesical medical

"is a Phase 2 open-label trial assessing 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.

tolerability medical

"interim safety and tolerability data from both BCG-Naïve and BCG-Unresponsive..."

Tolerability is how well patients can handle a medical treatment’s side effects and whether they can stay on the drug without unacceptable discomfort or harm. Investors watch tolerability because poor tolerability can reduce patient use, lead to trial failures, stricter labels or regulatory hurdles, and hurt sales—think of it like whether a product is comfortable enough for people to keep using regularly.

AI-generated analysis. Not financial advice.

NEW YORK, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated interim data from the cohort of BCG-Unresponsive non-muscle invasive bladder cancer (NMIBC) patients in the ongoing Phase 2 ADVANCED-2 trial of TARA-002 will be featured at the upcoming American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, taking place from February 26, 2026 to February 28, 2026 in San Francisco.

The poster presentation will include updated safety and efficacy data from approximately 25 six-month evaluable BCG-Unresponsive NMIBC patients in the ongoing Phase 2 ADVANCED-2 trial.

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 (Cohort B N=75-100) or BCG-Naïve (Cohort A N=31). 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.

Details of the poster presentations are as follows:

Title: ADVANCED-2: Interim efficacy and safety data in BCG-Unresponsive participants with high-grade non-muscle invasive bladder cancer

Poster Number: F15

Poster Track: Urothelial Carcinoma

Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma

Session Date and Time: Friday, February 27, 2026

In addition, interim safety and tolerability data from both BCG-Naïve and BCG-Unresponsive patients enrolled in ADVANCED-2 will also be presented.

Title: Interim safety and tolerability of TARA-002 in patients with BCG-Naïve and Unresponsive high-grade non-muscle invasive bladder cancer in ADVANCED-2 

Poster Number: H8

Poster Track: Urothelial Carcinoma

Session Title: Poster Session B: Prostate Cancer and Urothelial Carcinoma

Session Date: Friday, February 27, 2026

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 Designation by the U.S. Food and Drug Administration. 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.

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 release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, 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.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the sixth most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States 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 nutrition who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visit www.protaratx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include but are not limited to, statements regarding Protara’s intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara’s business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials (including the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials or phases thereof); statements related to expectations regarding interactions with the U.S. Food and Drug Administration (FDA); Protara’s financial position; statements regarding the anticipated safety or efficacy of Protara’s product candidates; and Protara’s outlook for the remainder of the year and future periods. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the uncertain nature of the forward-looking statements include: risks that Protara’s financial guidance may not be as expected, as well as risks and uncertainties associated with: Protara’s development programs, including the initiation and completion of non-clinical studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions; changes in the competitive landscape; changes in Protara’s strategic and commercial plans; Protara’s ability to obtain sufficient financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S. and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated with Protara’s business and financial condition in general, including the risks and uncertainties described more fully under the caption “Risk Factors” and elsewhere in Protara's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management's assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise, except as required by law.

Company Contact:

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

FAQ

What data will Protara (TARA) present at ASCO GU 2026 on Feb 27?

Updated interim safety and efficacy data from about 25 six-month evaluable BCG-unresponsive NMIBC patients in the Phase 2 ADVANCED-2 trial.

Which ADVANCED-2 cohorts are included in the ASCO GU posters for TARA-002?

Both Cohort B (BCG-unresponsive, N=75–100) and Cohort A (BCG-naïve, N=31) are included across the two posters.

When and where will the TARA-002 posters (F15 and H8) be presented?

Both posters are scheduled for Poster Session B on Friday, Feb 27, 2026 at the ASCO GU Cancers Symposium in San Francisco.

How is TARA-002 administered in the ADVANCED-2 trial (NCT05951179)?

Intravesical instillations: an induction course of six weekly doses (with or without reinduction), then maintenance of three weekly instillations every three months.

What is the sample size for the BCG-unresponsive cohort in ADVANCED-2?

Cohort B (BCG-unresponsive) is planned at N=75–100, with ~25 six-month evaluable patients reported in the interim poster.

Will the ASCO GU presentation include safety data for BCG-naïve patients?

Yes, interim safety and tolerability data covering both BCG-naïve and BCG-unresponsive patients will be presented in poster H8.