{"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","discovered_at":"2026-05-14T18:03:38.558876+00:00","generated_at":"2026-06-16T03:04:12.532939+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Protara gets FDA clearance to start Phase 2 STARBORN-1 trial of TARA-002 for pediatric lymphatic malformations","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-23-035154","json":"https://secwatch.observer/filing/0001213900-23-035154.json","markdown":"https://secwatch.observer/filing/0001213900-23-035154.md","text":"https://secwatch.observer/filing/0001213900-23-035154.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-16T03:04:12.532939+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}