Protara to Evaluate Updated Interim Results from Phase 2 Study of TARA-002 for Bladder Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Should l Buy TARA?
Source: NASDAQ.COM
Conference Call Announcement: Protara Therapeutics, Inc. will host a conference call on December 3, 2025, to discuss interim data from its phase 2 ADVANCED-2 trial assessing TARA-002 for high-risk non-muscle invasive bladder cancer (NMIBC).
Trial Cohorts: The ADVANCED-2 trial includes two cohorts: Cohort A consists of BCG-naïve patients or those who have not received BCG for 24 months, while Cohort B includes patients who are BCG-unresponsive within 12 months of adequate therapy.
Efficacy Results: TARA-002 showed promising results with a 100% complete response rate at any time and a 67% rate at 12 months in BCG-unresponsive patients, and a 76% complete response rate at any time and 43% at 12 months in BCG-naïve patients.
FDA Feedback Update: During the conference call, Protara will also provide updates on FDA feedback regarding the registrational path for TARA-002 in BCG-naïve patients.
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Analyst Views on TARA
Wall Street analysts forecast TARA stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 6.530
Low
23.00
Averages
25.50
High
30.00
Current: 6.530
Low
23.00
Averages
25.50
High
30.00
About TARA
Protara Therapeutics, Inc. is a clinical-stage biotechnology company, which is engaged in advancing transformative therapies for people with cancer and rare diseases. The Company’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 II trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naive to treatment with Bacillus Calmette-Guerin (BCG), as well as a Phase II trial in pediatric patients with LMs. In addition, the Company 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.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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- Clinical Trial Progress: The approval supports the company's competitiveness in the global market, as Glatiramer Acetate remains a key product despite revenue erosion from generics, highlighting its ongoing relevance in the biotech sector.
- Strategic Positioning: This approval not only strengthens ScinoPharm's position in the biopharmaceutical landscape but also lays the groundwork for future market expansions, demonstrating the company's commitment to innovative drug development.
See More
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- Patient Enrollment: The study plans to enroll approximately 105 patients to assess the efficacy and safety of low- and high-dose IV Choline Chloride, which is expected to significantly reduce the risks of hepatic injury and neuropsychological impairment faced by nearly 78% of long-term parenteral support patients.
- Regulatory Progress: IV Choline Chloride has received Fast Track and Orphan Drug Designation from the FDA, underscoring its potential in treating this underserved population, with interim analysis results anticipated in the second half of 2026.
- Market Performance: Protara's stock is currently trading at $5.46, reflecting a 6.42% increase from its 52-week low of $2.77, indicating positive market expectations and increased investor confidence in the new therapy.
See More
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- FDA Designation: Protara Therapeutics' TARA-002 has received both Breakthrough Therapy and Fast Track designations from the FDA, aimed at providing effective treatment for pediatric patients with lymphatic malformations, highlighting the drug's potential to address significant unmet medical needs.
- Accelerated Clinical Development: TARA-002 has been selected for the CMC Development and Readiness Pilot Program, which aims to support expedited clinical development, enabling earlier patient access to the therapy and significantly shortening the time to market.
- Market Opportunity: Lymphatic malformations are common in children, with over 50% of cases diagnosed at birth, and Protara's treatment is poised to fill a therapeutic gap in this area, addressing the growing market demand.
- Strategic Collaboration: Protara's CEO stated that the company will work closely with the FDA to define the registration pathway for TARA-002, with a meeting expected in the first half of this year to further advance the clinical application of this therapy.
See More
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- Successful Fundraising: Protara Therapeutics has completed a public offering of 13,043,479 shares at a price of $5.75 per share, raising approximately $75 million, which strengthens its financial position to support clinical projects.
- Clear Use of Proceeds: The net proceeds from this offering will be used for the clinical development of TARA-002 and other clinical programs, demonstrating the company's strong commitment to drug development aimed at driving future business growth.
- Strong Underwriting Team: J.P. Morgan, TD Cowen, and Piper Sandler acted as joint book-running managers for the offering, enhancing market confidence in the offering and indicating the company's solid reputation in capital markets.
- Compliance Assurance: The offering was conducted under an effective S-3 registration statement, ensuring compliance and reducing legal risks, thereby laying a foundation for future fundraising activities.
See More
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- Successful Fundraising: Protara Therapeutics has completed a public offering of 13,043,479 shares at $5.75 per share, raising approximately $75 million in gross proceeds, thereby enhancing its financial capacity to support clinical projects.
- Clear Use of Proceeds: The net proceeds from this offering will be directed towards the clinical development of TARA-002 and other clinical programs, demonstrating the company's ongoing commitment and strategic focus in the treatment of cancer and rare diseases.
- Strong Underwriting Team: The offering was managed by J.P. Morgan, TD Cowen, and Piper Sandler as joint book-running managers, which bolsters market confidence in Protara and enhances its brand influence.
- Regulatory Compliance Assurance: The shares were issued under an effective shelf registration statement on Form S-3, ensuring compliance and reducing future financing legal risks, further solidifying the company's position in the capital markets.
See More
Protara Secures $75 Million Funding to Support TARA-002 and Expand Pipeline Development
Stock Performance: Protara Therapeutics Inc. (TARA) shares fell over 18% to $5.55 in premarket trading following the announcement of a $75 million public offering of 13 million shares at $5.75 each.
Offering Details: The underwriters have a 30-day option to purchase an additional 1.95 million shares, with the offering expected to close around December 8, 2025, subject to customary conditions.
Use of Proceeds: The net proceeds from the offering will support the clinical development of TARA-002, an investigational cell therapy for non-muscle invasive bladder cancer and lymphatic malformations, as well as other clinical initiatives and general corporate purposes.
Current Trials and Designations: TARA-002 is in a Phase 2 trial for pediatric lymphatic malformations and has received Rare Pediatric Disease and Orphan Drug designations, while Protara is also advancing IV Choline Chloride, which has similar designations from the FDA.
See More
