Strong Interim Results from Protara’s TARA‑002 in Pediatric Lymphatic Malformations

1 December 2025

Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biopharmaceutical company focused on developing innovative therapies for cancer and rare diseases, has announced encouraging interim findings from its ongoing Phase 2 open-label STARBORN-1 trial. The study evaluates the intracystic administration of TARA-002, the company’s investigational cell-based therapy, in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs).

Jesse Shefferman, CEO of Protara Therapeutics, stated, “We are excited to share these strong interim results from the STARBORN-1 trial, which highlight TARA-002’s anticipated significant clinical benefit in treating macrocystic and mixed cystic LMs. The therapy produced meaningful clinical responses and demonstrated a favorable safety profile across all evaluable patients. When considered alongside prior data from studies involving TARA-002’s predecessor, OK-432, a recognized treatment for LMs in Japan, these findings reinforce our confidence in TARA-002’s potential as a valuable treatment option for pediatric patients affected by LMs.”

Explore comprehensive insights on Lymphatic Malformations Market Forecast, analyze epidemiology, market trends, and treatment landscape to guide strategic decisions through 2034.

How a DelveInsight Report Adds Value

DelveInsight is a well-regarded healthcare market‑research and consulting firm delivering comprehensive epidemiology, market forecast, and competitive‑landscape reports across therapeutic areas.

For a rare‑disease indication like LMs targeted by TARA‑002, a DelveInsight rare‑disease report would provide:

  • Epidemiology Assessment – accurate estimates of prevalence/incidence, geographic distribution, patient segmentation (age, severity, cyst type), and burden of disease across key geographies.
  • Market Forecast – projections of potential treatable patient pool over the next 5–10 years, factoring in disease natural history, diagnosis rates, and therapy uptake
  • Competitive Landscape & Unmet Need Analysis – mapping existing standard-of-care (surgical, off-label therapies), unmet needs, and potential competitive/complementary therapies. 
  • Pricing & Reimbursement Insight – evaluation of pricing strategies, payer landscapes, and value-based reimbursement frameworks, especially critical for rare pediatric conditions.
  • Indication Prioritization & Strategic Planning – assisting stakeholders (biotechs, investors, payers) to assess the commercial potential of TARA‑002 vs alternate indications or therapies. 

Thus, a DelveInsight report on pediatric Lymphatic Malformations (or similar rare‑disease markets) would help translate early clinical success of TARA‑002 into actionable market intelligence, supporting go/no‑go decisions, forecasting revenue potential, and guiding regulatory, pricing, and access strategies.

Conclusion:

The positive interim STARBORN-1 results from Protara’s TARA-002 with high clinical success and favorable safety in pediatric lymphatic malformations mark an encouraging early step toward filling a critical unmet need in rare pediatric disease. When combined with a detailed market‑intelligence framework from DelveInsight, stakeholders gain a holistic view: not only of clinical promise, but of the real-world epidemiology, market potential, reimbursement environment, and competitive dynamics. This integrated insight can guide strategic decisionmaking, helping bridge the gap between promising science and successful patient‑facing therapy.

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