Protara gets FDA rare pediatric disease designation for lymphatic malformation

Protara Therapeutics’ (NASDAQ:TARA) TARA-002 received FDA rare pediatric disease designation for the treatment of lymphatic malformation.

Lymphatic malformations are rare, typically congenital and result in the failure of lymphatic structures to connect or drain into the venous system. 

TARA-002 is a cellular therapy based on the broad immunopotentiator, OK-432, which is approved in Japan and Taiwan for the treatment of lymphatic malformations.

“Receipt of rare pediatric disease designation from the FDA for TARA-002 in lymphatic malformations further underscores the significant unmet medical need for the children that are affected by this rare and serious disease,” Jesse Shefferman, Protara’s CEO, said in a statement.

“We are encouraged about the potential of TARA-002 to enhance the treatment paradigm of lymphatic malformations for this underserved population, and we look forward to working with the agency to determine next steps for the program in the coming months,” he added.