TARA-002 pursues approval in pediatric LMs and NMIBC; BLA submission and registrational trial data will determine whether multi-indication value materializes

Protara Therapeutics is a clinical-stage biopharmaceutical company developing TARA-002 for pediatric lymphatic malformations and non-muscle-invasive bladder cancer, neither indication yet approved.

TARA-002 is being developed in pediatric macrocystic and mixed cystic lymphatic malformations and BCG-unresponsive and BCG-naïve NMIBC, with a BLA submission planned in H2 2027 for the LM indication. The thesis turns on whether STARBORN-1 pivotal data support a clean BLA filing and FDA approval in LMs, while ADVANCED-2 and ADVANCED-3 registrational data must demonstrate durable CRs sufficient for NMIBC approval. The primary competitive risk in NMIBC is ImmunityBio's approved ANKTIVA, which sets a high efficacy bar and may compress addressable market share before TARA-002 reaches approval.