Benzinga | Apr 23, 2021 07:05AM EDT

Protara Therapeutics Says Based On FDA Feedback, Co. Intends To Complete Confirmatory, Large-Scale GMP Manufacturing Comparability In 2H And Initial Clinical Study In Pediatric Lymphatic Malformations Pending Alignment With FDA On Study Design

Protara Therapeutics, Inc. (NASDAQ:TARA), a clinical stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet needs, today announced a path forward related to TARA-002 for the treatment of Lymphatic Malformations (LMs), which are rare malformations of the lymphatic vasculature for which there is no U.S. Food and Drug Administration (FDA)-approved treatment. Based on feedback from the FDA, the Company intends to complete confirmatory, large-scale, GMP manufacturing comparability in the second half of 2021 and subsequently initiate a clinical study in pediatric LM patients pending alignment with FDA on study design.