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. develops clinical-stage biotechnology programs for cancer and rare diseases. Company news centers on TARA-002, an investigational cell-based therapy being studied for non-muscle invasive bladder cancer and lymphatic malformations, including updates from the ADVANCED-2 trial in BCG-Unresponsive and BCG-Naïve NMIBC patient groups.
Recurring updates also cover IV Choline Chloride, an investigational phospholipid substrate replacement therapy for patients receiving long-term parenteral support. Other company announcements include clinical-conference presentations, FDA designation updates, financial results, equity compensation grants under Nasdaq rules, and capital-raising activity tied to Protara's development-stage pipeline.
Protara Therapeutics (Nasdaq: TARA) said 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 will be available via the company’s Events and Presentations page at https://ir.protaratx.com and the webcast will be archived for a limited time after the presentation.
Protara Therapeutics (Nasdaq: TARA) announced dosing of the first patient in the Phase 3 registrational THRIVE-3 trial of IV Choline Chloride for patients on long-term parenteral support (PS).
The investigational therapy has prior FDA Fast Track designation. THRIVE-3 is a seamless Phase 2b/3 design: an 8-week Phase 2b open-label dose-confirmation in 24 patients, followed by ~105 additional patients in a 24-week double-blind, randomized, placebo-controlled Phase 3. The primary endpoint is change in plasma choline concentration versus placebo. An interim analysis is expected in the second half of 2026. The company notes 78% of PS-dependent patients are impacted by choline deficiency and that no IV choline products are currently approved globally.
Protara Therapeutics (NASDAQ: TARA) announced that the U.S. FDA granted both Breakthrough Therapy and Fast Track designations for TARA-002 to treat pediatric macrocystic and mixed cystic lymphatic malformations (LMs) on January 5, 2026.
The FDA also selected TARA-002 for the Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program, and the program will cover manufacturing for both the company’s LMs and non-muscle invasive bladder cancer programs. TARA-002 previously received Rare Pediatric Disease designation. Management expects to meet with the FDA to define a path to registration for TARA-002 in LMs in the first half of 2026.
Protara (Nasdaq: TARA) announced the closing of an underwritten public offering on Dec 8, 2025 consisting of 13,043,479 shares at $5.75 per share, producing gross proceeds of approximately $75 million before underwriting discounts, commissions and offering expenses. The underwriters have a 30-day option to purchase up to an additional 1,956,521 shares at the public offering price.
Protara intends to use net proceeds to fund the clinical development of TARA-002, support other clinical programs, and for working capital and general corporate purposes. The shares were issued under an effective Form S-3 shelf registration declared effective on Nov 14, 2023.
Protara Therapeutics (NASDAQ: TARA) priced an underwritten public offering of 13,043,479 common shares at $5.75 per share, with gross proceeds of approximately $75 million before fees and expenses. The underwriters have a 30-day option to purchase up to an additional 1,956,521 shares at the public offering price, less underwriting discounts and commissions.
The offering is expected to close on December 8, 2025, and all shares are being sold by Protara. Net proceeds are intended to fund clinical development of TARA-002, other clinical programs, working capital, and general corporate purposes. J.P. Morgan, TD Cowen, and Piper Sandler are joint book-running managers.
Protara Therapeutics (Nasdaq: TARA) announced on December 4, 2025 a proposed underwritten public offering of $75 million aggregate principal amount of common stock or, for certain investors, pre-funded warrants to purchase common stock.
The company expects to grant underwriters a 30-day option to buy additional shares. Proceeds are intended to fund the clinical development of TARA-002, other clinical programs, working capital and general corporate purposes. The offering is subject to market and other conditions and will be made under a Form S-3 shelf registration declared effective on November 14, 2023. J.P. Morgan, TD Cowen and Piper Sandler are joint book-running managers.
Protara Therapeutics (Nasdaq: TARA) reported updated interim Phase 2 ADVANCED-2 data for TARA-002 in BCG-naïve non-muscle invasive bladder cancer (NMIBC) on Dec 3, 2025. The dataset included 31 treated patients and 29 evaluable for efficacy as of a Nov 7, 2025 cutoff.
Key efficacy: 72% complete response (CR) rate at any time (21/29); 69% CR at 6 months (18/26); 50% CR at 12 months (7/14). Among initial responders, 88% (14/16) maintained response to six months and 100% (3/3) to 12 months. Re-induction converted 80% (4/5) to CR at six months and 100% (4/4) maintained CR at 12 months.
Safety: mostly Grade 1 TRAEs, no Grade 3+ treatment-related adverse events, no discontinuations due to TRAEs. Regulatory: FDA provided written feedback supporting a registrational controlled trial design in BCG-naïve patients with intravesical chemotherapy as an acceptable comparator and month 6 CR as primary endpoint. Company expects BCG-unresponsive cohort updates in Q1 2026 and cohort enrollment completion in 2H 2026.
Protara Therapeutics (Nasdaq: TARA) will host a conference call and live webcast at 8:30 am ET on Wednesday, December 3, 2025 to review new interim data from the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in BCG-naïve non-muscle invasive bladder cancer (NMIBC) patients.
The interim data will also be presented in a poster session at the 26th Annual Meeting of the Society of Urologic Oncology (SUO). The company will provide an update on feedback received from the U.S. Food and Drug Administration concerning a registrational path forward for TARA-002 in BCG-naïve patients. A replay and slides will be archived for a limited time.
Protara Therapeutics (Nasdaq: TARA) reported positive interim Phase 2 STARBORN-1 results for intracystic TARA-002 in pediatric lymphatic malformations (data cutoff Nov 12, 2025).
In 12 enrolled patients, 8 were evaluable at eight weeks and 100% (8/8) achieved clinical success; 80% (8/10) of patients who completed treatment achieved clinical success. One large macrocystic patient required four doses and achieved a complete response; macrocystic complete response rate was 83% (5/6). Safety was favorable with no serious adverse events reported.
Protara Therapeutics (Nasdaq: TARA) will host a conference call and live webcast at 8:30 a.m. ET on Wednesday, November 19, 2025 to review new interim data from the Phase 2 open-label STARBORN-1 trial of TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations.
The event will include slides and a replay will be archived for a limited time. Access the live webcast via the company Events and Presentations page or the provided registration link.