secwatch.observer — SEC 8-K summary
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Issuer:     Protara Therapeutics, Inc. (TARA)
CIK:        0001359931
Form:       8-K
Filed at:   2023-05-02T23:59:59+00:00
Accession:  0001213900-23-035154
Event type: regulatory
Sentiment:  positive
Materiality: 0.55
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1359931/000121390023035154/0001213900-23-035154-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1359931/000121390023035154/ea177801-8k_protara.htm
  HTML page:      https://secwatch.observer/filing/0001213900-23-035154

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer