Protara Therapeutics Receives FDA Breakthrough and Fast Track Designations for TARA-002

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.