IV Choline Chloride
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Protara Therapeutics Announces Dosing of First Patient in Phase 3 Registrational THRIVE-3 Trial of IV Choline Chloride in Patients on Long-Term Parenteral Support
Globenewswire· 2026-01-07 13:00
NEW YORK, Jan. 07, 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 patient dosing is now underway in its Phase 3 registrational THRIVE-3 clinical trial evaluating intravenous (IV) Choline Chloride in patients receiving long-term parenteral support (PS). IV Choline Chloride, the Company’s investigational phospholipid substrate replacement therapy, was previously ...
Protara Therapeutics to Present at the 44th Annual J.P. Morgan Healthcare Conference
Globenewswire· 2026-01-07 13:00
NEW YORK, Jan. 07, 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 management will present at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, 2026, at 3:45 pm PT in San Francisco. A live webcast of the presentation can be accessed by visiting the Events and Presentations section of the Company’s website: https://ir.protaratx.com. The ...
Protara Therapeutics Receives Both FDA Breakthrough Therapy and Fast Track Designations for TARA-002 in Pediatric Patients with Lymphatic Malformations
Globenewswire· 2026-01-05 13:00
TARA-002 selected for FDA manufacturing development and readiness pilot programNEW YORK, Jan. 05, 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 the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the Company’s investigational cell-based therapy, for the treatment of pediatric patients wit ...
Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients on Wednesday, December 3, 2025
Globenewswire· 2025-12-01 21:15
NEW YORK, Dec. 01, 2025 (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 it will host a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-Naïve patients with non-muscle invasive bladder cancer (NMIBC). The data will be feature ...
Protara Therapeutics to Host Conference Call and Webcast to Review New Interim Data from Phase 2 STARBORN-1 Trial of TARA-002 in Pediatric Patients with Lymphatic Malformations on Wednesday, November 19, 2025
Globenewswire· 2025-11-18 21:30
Core Insights - Protara Therapeutics, Inc. is hosting a conference call on November 19, 2025, to discuss new data from the interim analysis of the Phase 2 STARBORN-1 trial for TARA-002, a cell-based therapy for pediatric patients with lymphatic malformations [1][2] Group 1: Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [5] - The company's lead candidate, TARA-002, is in development for non-muscle invasive bladder cancer and lymphatic malformations [5] - TARA-002 has received Rare Pediatric Disease designation from the U.S. FDA for the treatment of lymphatic malformations [3] Group 2: Product Details - TARA-002 is a genetically distinct strain of streptococcus pyogenes that retains immune-stimulating properties while being inactivated [3] - The therapy was developed from the same master cell banks as OK-432, which has been the standard of care in Japan for 30 years [3] - A large Phase 2 trial of OK-432 demonstrated significant clinical success in over 500 patients with lymphatic malformations [3] Group 3: Lymphatic Malformations - Lymphatic malformations are rare congenital conditions affecting lymphatic vessels, often diagnosed in early childhood [4] - More than 50% of lymphatic malformations are detected at birth, with 90% diagnosed before the age of three [4] - Common complications include airway obstruction, intralesional bleeding, and recurrent infections, leading to significant morbidity [4]
Protara Therapeutics to Present New Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients at the 26th Annual Meeting of the Society of Urologic Oncology
Globenewswire· 2025-11-17 13:00
Core Insights - Protara Therapeutics, Inc. announced interim data from the Phase 2 ADVANCED-2 trial of TARA-002 for treating non-muscle invasive bladder cancer (NMIBC) [1][2] - The trial data will be presented at the 26th Annual Meeting of the Society of Urologic Oncology from December 2 to December 5, 2025 [1] - TARA-002 is an investigational cell therapy that has received Rare Pediatric Disease Designation from the FDA [3][6] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases [6] - The company's lead candidate, TARA-002, is being evaluated in ongoing Phase 2 trials for NMIBC and lymphatic malformations [6] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [6] Trial Details - The ADVANCED-2 trial includes BCG-Naïve patients with NMIBC, specifically those with carcinoma in situ or CIS [2] - The trial involves an induction course of six weekly intravesical instillations of TARA-002, followed by maintenance treatments [2] - The upcoming poster presentation will include updated safety and efficacy data from 31 enrolled patients [1][3] Disease Context - NMIBC accounts for approximately 80% of bladder cancer diagnoses in the U.S., with around 65,000 new cases each year [5] - Bladder cancer is the sixth most common cancer in the United States [5] Mechanism of Action - TARA-002 is hypothesized to activate immune cells in the tumor, leading to a pro-inflammatory response and the release of cytokines [4] - The therapy aims to directly kill tumor cells and enhance the antitumor immune response through immunogenic cell death [4]
Protara Therapeutics Announces Third Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-11-10 13:00
Core Insights - Protara Therapeutics reported significant advancements in its clinical programs, particularly in the development of TARA-002 for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][5][10] - The company is on track to report interim results from its ADVANCED-2 trial in NMIBC patients in Q1 2026 and expects to provide updates on its STARBORN-1 trial for pediatric LMs in Q4 2025 [6][7] Clinical Development Updates - TARA-002 is being evaluated in the ADVANCED-2 trial for NMIBC, with interim results expected from approximately 25 BCG-Unresponsive patients in early 2026 [6][7] - The STARBORN-1 trial for TARA-002 in pediatric patients with LMs is progressing, with an interim update anticipated in Q4 2025 [5][6] - The THRIVE-3 trial for IV Choline Chloride is set to dose its first patient by the end of 2025, focusing on patients dependent on parenteral support [6][7] Financial Performance - As of September 30, 2025, Protara had approximately $134 million in cash and investments, expected to fund operations into mid-2027 [6][15] - Research and development expenses increased to $9.6 million in Q3 2025 from $8.1 million in the same period of 2024, primarily due to startup costs for the THRIVE-3 trial [15][23] - The company reported a net loss of $13.3 million, or $0.31 per share, for Q3 2025, compared to a net loss of $11.2 million, or $0.50 per share, in Q3 2024 [15][23] Corporate Recognition - Protara was recognized as one of BioSpace's Best Places to Work in November 2025, highlighting its strong culture and commitment to innovation [8]
Protara Therapeutics Named a 2026 Best Places to Work Winner by BioSpace
Globenewswire· 2025-11-04 21:05
Core Insights - Protara Therapeutics, Inc. has been recognized as one of the Best Places to Work by BioSpace for 2026, highlighting its status as a desirable employer in the biotech sector [1][2] - The company is particularly noted for its commitment to fostering a vibrant workplace culture that attracts top talent and inspires employees [2][3] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [4] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [4] - Protara is currently conducting a Phase 2 trial for TARA-002 in NMIBC patients who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as a Phase 2 trial in pediatric patients with LMs [4] - Additionally, the company is developing IV Choline Chloride, a phospholipid substrate replacement for patients on parenteral nutrition [4] Workplace Environment - Protara is located in the Flatiron District of New York City and emphasizes a modern, collaborative working environment that values integrity, tenacity, and teamwork [3] - The company offers competitive benefits and prioritizes professional development, inclusivity, and work-life balance [3] - The Best Places to Work nominations were based on votes from over 7,500 life sciences professionals, who evaluated companies on various attributes including compensation, innovation, and culture [3]
Analysts Predict Up to 840% Jump for These 2 ‘Strong Buy’ Penny Stocks
Yahoo Finance· 2025-09-21 10:15
Core Insights - Protara Therapeutics is a clinical-stage biotech company focused on developing treatments for cancer and rare diseases, with its lead program TARA-002 targeting non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [2][8] - TARA-002 utilizes a novel approach derived from a genetically distinct cell bank, functioning through dual mechanisms of directly killing tumor cells and stimulating an immune response [1][8] - The company is also advancing IV Choline Chloride for patients requiring parenteral nutrition, addressing a significant unmet need [10] TARA-002 Development - TARA-002 is currently being evaluated in a mid-stage study called ADVANCED-2 for NMIBC, showing promising early results with a 67% complete remission rate in BCG-unresponsive patients at six months [8][12] - In the Phase 2 STARBORN-1 trial for lymphatic malformations, two out of three pediatric patients achieved complete response after one injection, indicating a favorable safety profile [9][12] - Protara plans to deliver interim results for both trials in 1Q26 and 4Q25, respectively [8][9] Market Potential and Analyst Sentiment - Analysts project TARA-002 represents a potential market opportunity exceeding $500 million, with a strong buy consensus rating and a price target suggesting an 840% upside [12][13] - The average price target from analysts for TARA shares is $24.20, indicating a potential upside of approximately 659% [13] Financial Performance of Alpha Teknova - Alpha Teknova reported $10.3 million in revenue for 2Q25, a 7.3% year-over-year increase, with a reaffirmed full-year revenue guidance of $39-42 million [17] - The company is positioned to benefit from growth in the bioprocessing market, with expectations of over 20% revenue growth and 30%+ adjusted EBITDA margins in the long term [19][20] Analyst Ratings for Alpha Teknova - Alpha Teknova holds a strong buy consensus rating, with a price target of $12 indicating a potential one-year upside of approximately 159% [20]
Protara Therapeutics (NasdaqGM:TARA) FY Conference Transcript
2025-09-09 14:02
Summary of Protara Therapeutics FY Conference Call Company Overview - **Company**: Protara Therapeutics (NasdaqGM:TARA) - **Date of Conference**: September 09, 2025 Key Industry and Company Insights Lymphatic Malformations - The largest data set on lymphatic malformations was generated by the University of Iowa, involving over 550 patients across 27 centers [1] - Protara is preparing a registration package for FDA submission, leveraging this data set and experience from Japan to seek accelerated approval [1] - TARA-002 is positioned as a treatment for BCG-unresponsive patients, with a focus on its unique mechanism of action compared to BCG [2][3] Mechanism of Action - TARA-002 acts as a TLR2/NOD2 activator, differing significantly from BCG, which is a TLR4 activator [2] - TARA-002 has demonstrated three-year stability at refrigerated temperatures and can be administered easily without special handling [2] - The drug upregulates key cytokines such as TNF-alpha, interferon-gamma, and IL-12, which are important for immune activation, while down-regulating IL-8, associated with recurrence [3][4] Clinical Trials and Data - Protara is currently enrolling patients in an Advanced II study for NMIBC (non-muscle invasive bladder cancer) and plans to publish interim data in February [4] - The company has reported a complete response rate of over 70% at six months and over 40% at twelve months in BCG-naive patients [6] - A significant portion of BCG-eligible patients (approximately 35%) do not receive BCG treatment, presenting an opportunity for TARA-002 [5] Safety and Efficacy - TARA-002 has shown no treatment-related grade 3 adverse events, with common side effects being mild and related to administration [7] - The administration process is straightforward, with efficacy comparable to other products in development [8] IV Choline Chloride Program - Protara is also developing IV Choline Chloride as a therapy for patients on parenteral support, addressing metabolic deficiencies [9][10] - The pivotal study aims to demonstrate elevated choline levels in serum as a primary endpoint, with interim data expected in mid-2026 [10][11] Market Potential and Future Directions - The incidence of lymphatic malformations is estimated at 1 in 2,000 to 1 in 4,000 live births, with a significant portion being macrocystic [15][16] - Protara aims to expand TARA-002's application to other maxillofacial cysts, potentially addressing a larger patient population [17] - The company holds $146 million in cash, sufficient to fund operations through 2027 and multiple catalysts in 2026 [18] Additional Important Points - Protara is actively engaging with the FDA regarding study designs for BCG alternative settings [5] - The company is focused on differentiating its product profile to drive adoption in a competitive market [7] - The ongoing studies and data collection are critical for establishing TARA-002's efficacy and safety in various patient populations [12][14]