Welcome to our dedicated page for Protara Therapeutics news (Ticker: TARA), a resource for investors and traders seeking the latest updates and insights on Protara Therapeutics stock.
Protara Therapeutics, Inc. (Nasdaq: TARA) is a clinical-stage biotechnology company developing therapies for cancer and rare diseases, and its news flow reflects progress across its investigational programs. Company announcements frequently highlight updates on TARA-002, an investigational cell-based therapy in development for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs), as well as on IV Choline Chloride, an investigational phospholipid substrate replacement therapy for patients on long-term parenteral support.
Investors following TARA news can expect detailed coverage of clinical trial milestones, including interim data from the Phase 2 ADVANCED-2 trial in NMIBC and the Phase 2 STARBORN-1 trial in pediatric LMs. Recent press releases have discussed complete response rates, safety and tolerability findings, and regulatory feedback from the U.S. Food and Drug Administration (FDA) on potential registrational paths for TARA-002 in both BCG-unresponsive and BCG-naïve NMIBC populations.
News items also report on regulatory designations and programs, such as Breakthrough Therapy, Fast Track, and Rare Pediatric Disease designations for TARA-002 in LMs, and Fast Track and Orphan Drug Designations for IV Choline Chloride in patients on long-term parenteral nutrition. In addition, Protara’s releases describe participation of TARA-002 in the FDA’s Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program.
Another key theme in TARA news is capital markets activity, including underwritten public offerings of common stock under the company’s shelf registration statement on Form S-3, with proceeds directed toward the clinical development of TARA-002 and other programs. Corporate updates may reference conference presentations, such as appearances at healthcare conferences, and scheduled webcasts to review new clinical data.
By monitoring this news page, readers can follow Protara’s disclosed clinical data updates, regulatory interactions, financing events, and other material developments that the company reports through press releases and related communications.
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.
Protara Therapeutics (Nasdaq: TARA) announced results from THRIVE-1, a study evaluating choline deficiency and liver injury in patients dependent on parenteral support (PS). Key findings:
- 78% of PS-dependent patients were choline deficient
- 63% of choline-deficient participants had liver dysfunction
These results underscore the need for intravenous (IV) choline supplementation. Protara is developing IV Choline Chloride as a treatment when oral or enteral nutrition is insufficient. The company plans to initiate a registrational trial in Q1 2025. Currently, there are no approved IV choline products for PS-dependent patients globally, despite recommendations from medical societies.
Protara Therapeutics (Nasdaq: TARA), a clinical-stage company focused on developing therapies for cancer and rare diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's management will present on Monday, September 9, 2024, at 1:30 pm ET in New York.
Investors and interested parties can access a live webcast of the presentation through the Events and Presentations section of Protara's website at https://ir.protaratx.com. The webcast will be available for a time after the presentation concludes, providing an opportunity for those unable to attend the live event to catch up on the company's latest developments and strategic outlook.
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