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Protara Therapeutics, Inc. (symbol: TARA) is a clinical-stage biopharmaceutical company specializing in identifying and advancing transformative therapies for individuals afflicted with rare and specialty diseases. Headquartered in New York, New York, the company’s mission is to discover, develop, and deliver breakthrough treatments for patients who have limited therapeutic options.
Protara’s leading program is TARA-002, an investigational cell therapy designed for the treatment of lymphatic malformations (LMs), a condition characterized by fluid-filled cysts. In a significant advancement for the company, TARA-002 has been granted the Rare Pediatric Disease designation by the U.S. Food and Drug Administration (FDA), spotlighting its potential impact on pediatric patients.
Another key asset in Protara’s pipeline is the development of intravenous (IV) choline chloride, a phospholipid substrate replacement therapy aimed at treating Intestinal Failure-Associated Liver Disease (IFALD). This investigational therapy underscores the company's commitment to addressing critical needs in the realm of pediatric and adult rare diseases.
The company's history dates back to its former identity as Artara Therapeutics, Inc. The name change to Protara Therapeutics, Inc. occurred in May 2020, reflecting a refreshed vision and strategic direction.
Protara’s forward-looking strategies are built upon solid research and development foundations, extensive clinical trial engagements, and meaningful partnerships. With recent financial updates, the company has ensured that its cash reserves, bolstered by anticipated net proceeds, can sustain its strategic plans into 2026. This financial planning provides a stable runway for Protara to continue its pioneering work and achieve significant milestones.
The company is actively involved in various clinical trials and regulatory interactions, aiming to bring its innovative therapies to market. Protara’s operational transparency and forward-looking statements indicate a robust business strategy focused on long-term growth and patient success.
For the latest updates on Protara Therapeutics, including performance, events, and developments, visit Protara Therapeutics or contact their offices directly at Justine O'Malley, Justine.OMalley@protaratx.com, 646-817-2836.
Protara Therapeutics (Nasdaq: TARA) has completed its public offering, raising $100 million in gross proceeds. The offering included 13,690,000 common stock shares at $6.25 per share and pre-funded warrants for 2,325,372 shares at $6.249 each. Underwriters received a 30-day option to purchase up to 2,402,305 additional shares. The company plans to use the proceeds to fund the clinical development of TARA-002 and other clinical programs, along with working capital and general corporate purposes. The offering was managed by TD Cowen, Cantor, LifeSci Capital, Oppenheimer & Co., and Scotiabank as joint book-running managers.
Protara Therapeutics (Nasdaq: TARA) has announced the pricing of its $100 million public offering, consisting of 13,690,000 common stock shares at $6.25 per share and 2,325,372 pre-funded warrants at $6.249 each. The company has granted underwriters a 30-day option to purchase up to 2,402,305 additional shares. The offering is expected to close on December 11, 2024.
The net proceeds will fund the clinical development of TARA-002 and other clinical programs, along with working capital and general corporate purposes. TD Cowen, Cantor, LifeSci Capital, Oppenheimer & Co., and Scotiabank are serving as joint book-running managers for the offering.
Protara Therapeutics (Nasdaq: TARA) has announced the commencement of an underwritten public offering of common stock shares and pre-funded warrants. The company plans to grant underwriters a 30-day option to purchase additional shares at the public offering price, less underwriting discounts and commissions. The net proceeds will be used to fund the clinical development of TARA-002 and other clinical programs, along with working capital and general corporate purposes. TD Cowen, Cantor, LifeSci Capital, Oppenheimer & Co., and Scotiabank are acting as joint book-running managers. The securities will be issued under a shelf registration statement that was declared effective on November 14, 2023.
Protara Therapeutics announced positive results from its ongoing Phase 2 ADVANCED-2 trial of TARA-002 in Non-Muscle Invasive Bladder Cancer (NMIBC) patients. The trial demonstrated a 72% six-month complete response rate across BCG exposures, with notable results in both BCG-Unresponsive (100%) and BCG-Naïve (64%) patients.
Key highlights include an 80% reinduction salvage rate and 100% of patients maintaining complete response from three to six months. The study showed a favorable safety profile with no Grade 2 or greater treatment-related adverse events. The dataset included 20 patients evaluable at three months, 18 at six months, and 3 at nine months, with data cutoff on November 19, 2024.
Protara Therapeutics (Nasdaq: TARA) announced a conference call and webcast scheduled for December 5, 2024, at 8:30 a.m. ET to discuss new interim data from their Phase 2 ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC). The data will also be presented during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology at 1:15 p.m. CT on the same day. Interested participants can register online to receive dial-in information, and a webcast will be available on the company's website.
Protara Therapeutics (Nasdaq: TARA) announced upcoming presentation of interim data from its Phase 2 ADVANCED-2 trial of TARA-002 for non-muscle invasive bladder cancer (NMIBC) at the Society of Urologic Oncology Annual Meeting. The presentation will include safety data and new efficacy results from approximately 20 enrolled patients. The ADVANCED-2 trial is an open-label study evaluating intravesical TARA-002 in NMIBC patients with carcinoma in situ who are BCG-unresponsive or BCG-naïve. The BCG-Unresponsive cohort (n≈100) is designed to be registrational in alignment with FDA's 2024 guidance, while the BCG-Naïve cohort targets 27 patients.
Protara Therapeutics provided Q3 2024 updates on its clinical programs. The company remains on track to report interim data from the ADVANCED-2 trial of TARA-002 in NMIBC patients in Q4 2024, with 12-month data expected mid-2025. In the Phase 2 STARBORN-1 trial, TARA-002 showed promising results in pediatric LMs patients. The company received FDA Fast Track designation for IV Choline Chloride, with first patient dosing in THRIVE-3 trial expected in Q1 2025.
Financial results showed cash position of $81.5 million, expected to fund operations into 2026. Q3 2024 net loss was $11.2 million ($0.50 per share), compared to $9.9 million ($0.87 per share) in Q3 2023.
Protara Therapeutics (Nasdaq: TARA), a clinical-stage company focused on developing therapies for cancer and rare diseases, has announced its upcoming participation in the Guggenheim Inaugural Healthcare Innovation Conference. The company's management will engage in a fireside chat on Wednesday, November 13, 2024, at 2:00 pm ET in Boston. The event will be accessible via live webcast through the Events and Presentations section of Protara's website, with a temporary archive available post-presentation.
Protara Therapeutics (Nasdaq: TARA) has received Fast Track designation from the FDA for its Intravenous (IV) Choline Chloride therapy. This investigational treatment is designed for adult and adolescent patients on parenteral support (PS) who cannot receive sufficient nutrition orally or enterally. The designation highlights the urgent need for such treatment, as approximately 80% of PS-dependent patients experience choline deficiency, which can lead to severe health complications.
Protara plans to initiate the registrational THRIVE-3 clinical trial in Q1 2025. This seamless Phase 2b/3 trial will assess the safety and efficacy of IV Choline Chloride in a double-blinded, randomized, placebo-controlled study. The primary endpoint will measure the change in plasma choline concentration from baseline compared to placebo. Currently, there are no FDA-approved IV choline products for PS-dependent patients globally, despite recommendations from major nutrition societies.
Protara Therapeutics (Nasdaq: TARA) has completed the first cohort of its Phase 2 STARBORN-1 trial for TARA-002, an investigational cell-based immunopotentiator for treating pediatric lymphatic malformations (LMs). The initial results are promising, with two out of three patients achieving complete responses after a single dose. The safety profile was consistent with historical data, showing mild to moderate, resolvable adverse events.
The trial aims to enroll about 30 patients aged 6 months to 18 years, with initial results from the next cohort expected in 1H'25. The primary endpoint is the proportion of participants demonstrating clinical success, defined as a substantial or complete reduction in LM volume. This development is significant as there are currently no FDA-approved treatments for LMs, a rare condition primarily affecting children.
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