---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-23-035154"
form_type: "8-K"
ticker: "TARA"
cik: "0001359931"
company_name: "Protara Therapeutics, Inc."
filed_at: "2023-05-02T23:59:59+00:00"
generated_at: "2026-06-16T03:04:12.532939+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Protara gets FDA clearance to start Phase 2 STARBORN-1 trial of TARA-002 for pediatric lymphatic malformations

## Summary
- FDA cleared the Phase 2 STARBORN-1 trial of TARA-002 (cell-based immunopotentiator) in pediatric patients with lymphatic malformations.
- Trial is single-arm, open-label, enrolling ~30 patients aged 6 months to <18 years; primary endpoint is clinical success (≥60% volume reduction).
- TARA-002 previously granted Rare Pediatric Disease designation by FDA; trial initiation expected in Q4 2023.
- Predecessor therapy OK-432 is approved in Japan and Taiwan and was studied in a U.S. compassionate-use program of over 500 patients.

## SEC filing metadata
- accession: 0001213900-23-035154
- form_type: 8-K
- ticker: TARA
- cik: 0001359931
- company_name: Protara Therapeutics, Inc.
- filed_at: 2023-05-02T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1359931/000121390023035154/0001213900-23-035154-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1359931/000121390023035154/ea177801-8k_protara.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-23-035154
- JSON: https://secwatch.observer/filing/0001213900-23-035154.json
- Plain text: https://secwatch.observer/filing/0001213900-23-035154.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.