{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-156074","form_type":"8-K","ticker":"GRTX","cik":"0001563577","company_name":"Galera Therapeutics, Inc.","filed_at":"2023-05-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:39.405961+00:00","generated_at":"2026-06-14T11:40:51.355621+00:00","sec_items":["8.01"],"event_type":"litigation","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Galera Therapeutics sues CROs over Phase 3 ROMAN trial statistical error","bullets":["Filed lawsuit in Pennsylvania against Alira Health Clinical and IQVIA Biotech for breach of contract and negligence.","Error in 2021 statistical program for Phase 3 ROMAN trial corrected; yielded statistically significant p-values for primary and key secondary endpoints.","Litigation is in early stages; company cannot predict outcome at this time.","FDA accepted NDA for avasopasem with Priority Review; PDUFA target date August 9, 2023."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-156074","json":"https://secwatch.observer/filing/0001193125-23-156074.json","markdown":"https://secwatch.observer/filing/0001193125-23-156074.md","text":"https://secwatch.observer/filing/0001193125-23-156074.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1563577/000119312523156074/0001193125-23-156074-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1563577/000119312523156074/d465209d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T11:40:51.355621+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"}