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) reported interim Phase 2 ADVANCED-2 results for intravesical TARA-002 in high-risk NMIBC cohorts as of Jan 28, 2026.
Key highlights: BCG-Unresponsive cohort six-month CR 68.2% (15/22) and any-time CR 65.7% (23/35); BCG-Naïve any-time CR 72.4% (21/29). No Grade 3+ treatment-related adverse events; enrollment for the BCG-Unresponsive registrational cohort expected to complete in 2H 2026.
Protara Therapeutics (Nasdaq: TARA) said management will present at two investor conferences in late February and early March 2026.
Virtual fireside chat at the Oppenheimer 36th Annual Healthcare Life Sciences Conference is scheduled for Feb 26, 2026 at 2:40 PM ET, and an in-person fireside chat at TD Cowen 46th Annual Health Care Conference is scheduled for Mar 3, 2026 at 2:30 PM ET in Boston. Live webcasts and limited-time archives are available via the company’s Events and Presentations webpage.
Protara Therapeutics (Nasdaq: TARA) granted inducement equity awards to a newly hired employee under Nasdaq Listing Rule 5635(c)(4). The Compensation Committee approved 10,200 stock options (exercise price $7.04) granted on Feb 2, 2026 and 5,100 RSUs with a grant date of Apr 1, 2026.
Options vest over four years (25% at one year, then monthly over 36 months). RSUs vest over three years in three equal annual installments, subject to continued service.
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.