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 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.
Protara Therapeutics (Nasdaq: TARA) will present interim data from Cohort A of the Phase 2 ADVANCED-2 trial of TARA-002 in BCG-naïve non-muscle invasive bladder cancer (NMIBC) at the 26th Annual Meeting of the Society of Urologic Oncology in Phoenix, Dec 2–5, 2025.
The poster will report updated safety and efficacy from 31 enrolled BCG-naïve patients, the majority having reached the six-month evaluation. ADVANCED-2 (NCT05951179) is an open-label Phase 2 trial evaluating intravesical TARA-002 in CIS (± Ta/T1) patients with BCG-unresponsive (~100) or BCG-naïve (31) cohorts. Poster details: Poster 149, Session: Bladder Cancer, Dec 4, 2025, 2:30–3:30 p.m. CT.
Protara Therapeutics (Nasdaq: TARA) reported third quarter 2025 results and provided a program update on November 10, 2025. The company had $133.6 million in cash, cash equivalents and marketable debt securities as of September 30, 2025, which it expects will fund operations into mid-2027. Key clinical milestones: interim readout from the Phase 2 STARBORN-1 pediatric LMs trial expected in 4Q 2025; interim analysis of ~25 six-month evaluable BCG-unresponsive NMIBC patients in ADVANCED-2 expected in 1Q 2026; first dosing in THRIVE-3 registrational IV Choline Chloride trial now expected by year-end 2025.
Q3 expenses rose; net loss was $13.3M ($0.31/share).
Protara Therapeutics (Nasdaq: TARA) was named a BioSpace 2026 Best Places to Work winner on November 4, 2025.
The company received the award in BioSpace’s small employer category and is one of 50 U.S. employers recognized (20 large, 30 small). Protara highlighted its Flatiron District, New York City office, a collaborative culture, competitive benefits, and emphasis on professional development, inclusivity, and work-life balance.
Management framed the award as recognition of employee commitment to advancing Protara’s clinical-stage programs in cancer and rare diseases and invited interest via the company careers page.
Protara Therapeutics (Nasdaq: TARA), a clinical-stage company focused on cancer and rare disease therapies, has granted inducement equity awards to a new employee. The compensation package includes 6,200 stock options at an exercise price of $4.41 per share and 3,100 restricted stock units (RSUs).
The stock options will vest over four years, with 25% vesting after one year and the remainder vesting monthly over 36 months. The RSUs will vest over three years, with one-third vesting annually. These grants were approved under Nasdaq Listing Rule 5635(c)(4) as material inducement for employment.
Protara Therapeutics (Nasdaq: TARA), a clinical-stage company focused on cancer and rare disease therapies, has granted inducement equity awards to two new employees. The compensation package includes 6,200 stock options at an exercise price of $3.17 per share and 3,100 RSUs.
The stock options will vest over four years with 25% vesting after one year and the remainder monthly over 36 months. The RSUs will vest over three years with 33 1/3% vesting annually. These grants were approved under Nasdaq Listing Rule 5635(c)(4) as material inducements for employment.
["Ability to attract new talent with equity compensation", "Structured vesting schedule promotes employee retention"]Protara Therapeutics (Nasdaq: TARA), a clinical-stage company focused on cancer and rare disease therapies, has announced its participation in two upcoming investor conferences.
The company will participate in a fireside chat at the Cantor Global Healthcare Conference on September 4, 2025, at 1:35 pm ET, and deliver a corporate presentation at the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 9:00 am ET. Both events will take place in New York.
Webcasts of both presentations will be available on the company's investor relations website and archived for a limited time.