{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-269333","form_type":"8-K","ticker":"GRTX","cik":"0001563577","company_name":"Galera Therapeutics, Inc.","filed_at":"2022-10-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.172871+00:00","generated_at":"2026-06-23T00:49:24.167225+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Galera presents positive Phase 3 ROMAN one-year data; meta-analysis confirms SOM reduction; NDA on track","bullets":["One-year follow-up: avasopasem maintained comparable tumor outcomes and overall survival vs placebo in HNC patients.","CKD incidence 10% (avasopasem) vs 20% (placebo) at one year (p=0.0043), a 50% reduction.","Meta-analysis (n=551): avasopasem reduced SOM incidence by 19% (p=0.0053) and median days of SOM by 58% (p=0.0002).","Meta-analysis also showed 28% delay in SOM onset (p=0.0005) and 32% reduction in Grade 4 incidence (p=0.0102).","NDA submission for avasopasem for radiotherapy-induced SOM still on track for end of 2022."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-269333","json":"https://secwatch.observer/filing/0001193125-22-269333.json","markdown":"https://secwatch.observer/filing/0001193125-22-269333.md","text":"https://secwatch.observer/filing/0001193125-22-269333.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1563577/000119312522269333/0001193125-22-269333-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1563577/000119312522269333/d399266d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T00:49:24.167225+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"}