IV Choline Chloride

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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]
Protara Therapeutics Announces Second Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-08-11 12:00
Core Insights - Protara Therapeutics, Inc. reported financial results for Q2 2025, highlighting ongoing clinical trials and business updates [1][10] Clinical Development - The company is advancing its pipeline, particularly the ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC), with interim results expected in Q1 2026 [2][7] - Protara is on track to initiate dosing in the THRIVE-3 trial of IV Choline Chloride for patients dependent on parenteral support by the end of Q3 2025, with EU enrollment anticipated soon [4][7] - The STARBORN-1 trial of TARA-002 in pediatric patients with lymphatic malformations is ongoing, with an interim update expected in Q4 2025 [5][7] Financial Performance - As of June 30, 2025, Protara had approximately $146 million in cash and equivalents, sufficient to support operations into mid-2027 [7][16] - Research and development expenses increased to $10.8 million in Q2 2025 from $6.4 million in the same period of 2024, primarily due to clinical trial activities [16][22] - The company reported a net loss of $15.0 million, or $0.35 per share, compared to a net loss of $9.5 million, or $0.45 per share, in Q2 2024 [16][23] Corporate Updates - William "Bill" Conkling was appointed as Chief Commercial Officer in June 2025, bringing over 20 years of experience in developing and commercializing novel therapeutics [6][9] - Protara was added to the Russell 3000® Index effective June 30, 2025, enhancing its visibility in the market [9]
Protara Therapeutics Announces Addition to the Russell 3000® Index
Globenewswire· 2025-06-30 12:00
Group 1 - Protara Therapeutics has been added to the Russell 3000 Index, effective June 30, 2025, reflecting the company's progress in executing its pipeline [1][2] - The inclusion in the Russell 3000 Index enhances Protara's visibility among the financial community, which is crucial for attracting investment and generating shareholder value [2] - The Russell US Indexes reconstitution captures the 4,000 largest U.S. stocks ranked by market capitalization, with approximately $10.6 trillion in assets benchmarked against these indices as of June 2024 [2] Group 2 - Protara is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with its lead candidate being TARA-002 [3] - TARA-002 is currently undergoing Phase 2 trials for non-muscle invasive bladder cancer and lymphatic malformations, targeting patients unresponsive to Bacillus Calmette-Guérin treatment [3] - The company is also developing IV Choline Chloride for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [3]
Protara Therapeutics Announces Appointment of William Conkling as Chief Commercial Officer
Globenewswire· 2025-06-02 20:04
Core Insights - Protara Therapeutics has appointed William "Bill" Conkling as Chief Commercial Officer, bringing over 20 years of experience in developing and commercializing therapies for cancer and rare diseases [1][2][3] - The company is positioned for growth with a potentially best-in-class bladder cancer therapy and two de-risked rare disease programs, aiming to significantly impact patient outcomes [2][5] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on transformative therapies for cancer and rare diseases, with its lead candidate TARA-002 in development for non-muscle invasive bladder cancer and lymphatic malformations [5] - The company is conducting ongoing Phase 2 trials for TARA-002 in patients with carcinoma in situ who are unresponsive or naïve to Bacillus Calmette-Guérin treatment, as well as in pediatric patients with lymphatic malformations [5] Leadership Background - Bill Conkling previously served as President and CEO of Rafael Holdings, where he built the commercial organization and developed go-to-market strategies [2][3] - He has extensive experience in the oncology field, having led the U.S. commercial organization for the launch of Trodelvy at Immunomedics and held key roles at Novartis Pharmaceuticals, including the commercialization of Kymriah [3][4] Stock Options and Awards - As part of his employment, Mr. Conkling received an inducement grant of options to purchase 200,000 shares at an exercise price of $3.30, along with a restricted stock unit award for 50,000 shares [6] - The options will vest over four years, with 25% vesting on the first anniversary and the remainder vesting monthly over the following 36 months [6]
Protara Therapeutics to Participate in Upcoming Investor Conferences
Globenewswire· 2025-05-13 12:00
Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [2] - 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) [2] - Protara is conducting an ongoing Phase 2 trial for TARA-002 in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to Bacillus Calmette-Guérin (BCG) treatment, as well as a Phase 2 trial in pediatric patients with LMs [2] Upcoming Events - Protara management will participate in the H.C. Wainwright & Co. 3 Annual BioConnect Investor Conference with a fireside chat scheduled for May 20, 2025, at 12:30 pm ET in New York [3] - The company will also take part in the TD Cowen 6 Annual Oncology Innovation Summit, which will be held virtually on May 27, 2025, at 1:30 pm ET [3] Additional Information - Protara is also developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [2] - Live webcasts of the investor conferences will be available on the company's website and archived for a limited time [1]
Protara Therapeutics Announces First Quarter 2025 Financial Results and Provides Business Update
Globenewswire· 2025-05-08 12:00
Core Insights - Protara Therapeutics reported significant progress in 2025, particularly with positive interim results from the ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) [2][5] - The company plans to initiate the THRIVE-3 Phase 3 clinical trial for IV Choline Chloride in Q3 2025, targeting patients on parenteral support [4][5] - Protara's financial results for Q1 2025 show a net loss of $11.9 million, with cash reserves expected to support operations into 2027 [14][24] Recent Progress and Highlights - TARA-002 demonstrated a complete response (CR) rate of 100% in BCG-Unresponsive patients and 76% in BCG-Naïve patients during the ADVANCED-2 trial [6] - The company expects to announce interim results from approximately 25 six-month evaluable BCG-Unresponsive patients by the end of 2025 [5][6] - Leadership team strengthened with key appointments, including Dr. Leonardo Viana Nicacio as Chief Medical Officer [9] Financial Overview - As of March 31, 2025, Protara had cash, cash equivalents, and investments totaling $158 million, sufficient to fund operations into 2027 [5][14] - Research and development expenses increased to $9.1 million in Q1 2025 from $7.7 million in the prior year, primarily due to clinical trial activities [14][24] - General and administrative expenses rose to $5.0 million in Q1 2025 from $4.1 million in the prior year [14][24] Product Development - TARA-002 is being evaluated for NMIBC and lymphatic malformations (LMs), with ongoing trials expected to yield interim updates in the second half of 2025 [8][11] - IV Choline Chloride is positioned as a potential first FDA-approved IV choline formulation for patients on parenteral nutrition [16] - The company continues to explore combination treatments and dosing strategies for TARA-002 in NMIBC patients [6][12]
Protara Therapeutics, Inc. Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-05-01 20:09
Core Insights - Protara Therapeutics, Inc. has granted inducement non-qualified stock options and restricted stock units (RSUs) to six newly-hired employees as part of its 2020 Inducement Plan [1][2][3] Employee Compensation - Shane Williams, the new Vice President, Head of Human Resources and Chief People Officer, received 41,000 stock option awards and 20,500 RSU awards with an exercise price of $4.32 per share on April 25, 2025 [2] - An aggregate of 59,100 stock option awards and 29,550 RSU awards were granted to five new employees on May 1, 2025, with an exercise price of $3.46 per share [3] Vesting Schedule - All option awards vest over four years, with 25% vesting on the one-year anniversary and the remainder vesting monthly thereafter [4] - RSU awards vest over three years, with 33 1/3% vesting on each of the three consecutive anniversaries of the grant date [4] Company Overview - Protara is a clinical-stage biotechnology company focused on developing therapies for cancer and rare diseases, including its lead candidate TARA-002 for non-muscle invasive bladder cancer and lymphatic malformations [5] - The company is conducting ongoing Phase 2 trials for TARA-002 in patients with carcinoma in situ and pediatric patients with lymphatic malformations [5] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition who cannot meet their choline needs through oral or enteral routes [5]
Protara Therapeutics to Host Conference Call and Webcast to Review Interim Data from Phase 2 ADVANCED-2 Trial of TARA-002 in Patients with NMIBC on Monday, April 28, 2025
Newsfilter· 2025-04-23 12:00
Core Viewpoint - Protara Therapeutics is set to present updated safety and efficacy data from the Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) on April 28, 2025, with data showcased at the American Urological Association 2025 Annual Meeting on April 26, 2025 [1][2] Group 1: Company Overview - Protara Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases [7] - The company's lead candidate, TARA-002, is an investigational cell-based therapy aimed at treating NMIBC and lymphatic malformations (LMs) [7] - Protara is also developing IV Choline Chloride for patients on parenteral nutrition [7] Group 2: Clinical Trial Details - The ADVANCED-2 trial (NCT05951179) is a Phase 2 open-label study assessing TARA-002 in NMIBC patients who are BCG-unresponsive or BCG-naïve [3] - The trial includes approximately 100 BCG-unresponsive patients and 31 BCG-naïve patients, with the BCG-unresponsive cohort designed to be registrational [3] Group 3: Product Information - TARA-002 is derived from a master cell bank of genetically distinct group A Streptococcus pyogenes, similar to OK-432, which is marketed in Japan [4] - The therapy is hypothesized to activate immune cells and induce a pro-inflammatory response, enhancing the antitumor immune response [5] Group 4: Disease Context - NMIBC accounts for about 80% of bladder cancer diagnoses, with approximately 65,000 new cases diagnosed annually in the United States [6]
Protara Therapeutics Announces Appointment of Leonardo Viana Nicacio, M.D., as Chief Medical Officer
Globenewswire· 2025-04-15 20:13
Core Viewpoint - Protara Therapeutics has appointed Dr. Leonardo Viana Nicacio as Chief Medical Officer, bringing nearly 20 years of experience in oncology and drug development to the company [1][2]. 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 an investigational cell-based therapy for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs) [5]. - Protara is 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 [5]. Leadership Appointment - Dr. Nicacio previously served as Head of Clinical Development and Global Medical Affairs at Stemline Therapeutics, where he established global solid tumor development strategies [2]. - His experience includes significant roles at Seagen, AstraZeneca, Flatiron Health, Sanofi, and YM Biosciences, focusing on oncology and drug development [3]. - Dr. Nicacio holds a Medical Degree from Faculdade de Ciencias Medicas de Minas Gerais and is board-certified in internal medicine and medical oncology [4]. Future Prospects - Dr. Nicacio expressed optimism about Protara's pipeline, highlighting the potential to impact patients with underserved cancers and rare diseases [4]. - Important milestones are anticipated, including the presentation of interim data from the ADVANCED-2 clinical trial of TARA-002 in NMIBC patients later this month [4]. Compensation Details - As part of his employment, Dr. Nicacio received an inducement grant of options to purchase 150,000 shares at an exercise price of $4.17, along with a restricted stock unit (RSU) award for 50,000 shares [6][7].