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) will present updated interim data from the Phase 2 ADVANCED-2 trial of TARA-002 at the ASCO Genitourinary Cancers Symposium in San Francisco, Feb 26–28, 2026.
The poster will report safety and efficacy from approximately 25 six-month evaluable BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients in Cohort B. ADVANCED-2 (NCT05951179) is an open-label Phase 2 study of intravesical TARA-002 with Cohort B (BCG-unresponsive, N=75–100) and Cohort A (BCG-naïve, N=31). Dosing: six weekly induction instillations (with optional reinduction) followed by three weekly maintenance instillations every three months.
Poster details: F15 (interim efficacy/safety in BCG-unresponsive) and H8 (interim safety/tolerability across cohorts), both scheduled for Poster Session B on Friday, Feb 27, 2026.
Protara Therapeutics (Nasdaq: TARA) highlighted 2026 milestones: on track to report interim results from ~25 six-month evaluable BCG-unresponsive patients in the ADVANCED-2 trial in Q1 2026; TARA-002 received FDA Breakthrough Therapy and Fast Track designations for pediatric macrocystic and mixed cystic lymphatic malformations with a regulatory update expected in 1H 2026; first patient dosed in registrational THRIVE-3 IV Choline Chloride trial with interim results expected in 2H 2026; selected for FDA CMC Readiness Pilot; and completed an ~$86 million public offering expected to extend cash runway into 2028.
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.
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