Protara Therapeutics Receives FDA Breakthrough and Fast Track Designations for TARA-002
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Protara Therapeutics announced that the U.S. Food and Drug Administration has granted both Breakthrough Therapy and Fast Track designations for TARA-002, the company's investigational cell-based therapy, for the treatment of pediatric patients with macrocystic and mixed cystic lymphatic malformations. In addition, the FDA has selected TARA-002 to participate in the Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program, which aims to support CMC development of products with expedited clinical development timeframes and provide patients with earlier access, the company stated. "Receiving these important FDA designations and invitation to participate in the CDRP program highlights the significant unmet need among pediatric patients with LMs and underscores our belief that TARA-002 could serve as a meaningful treatment option for this underserved patient population. We look forward to continuing to work with the Agency to bring this promising therapy to patients as expeditiously as possible and expect to meet with the FDA to define the path to registration for TARA-002 in LMs in the first half of this year," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics.
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Analyst Views on TARA
Wall Street analysts forecast TARA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for TARA is 24.83 USD with a low forecast of 21.00 USD and a high forecast of 30.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 7.170
Low
21.00
Averages
24.83
High
30.00
Current: 7.170
Low
21.00
Averages
24.83
High
30.00
About TARA
Protara Therapeutics, Inc. is a clinical-stage biotechnology company, which is engaged in advancing transformative therapies for people with cancer and rare diseases. The Company’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase II trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naive to treatment with Bacillus Calmette-Guerin (BCG), as well as a Phase II trial in pediatric patients with LMs. In addition, the Company is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral or enteral routes.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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