{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-302295","form_type":"8-K","ticker":"GRTX","cik":"0001563577","company_name":"Galera Therapeutics, Inc.","filed_at":"2022-12-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.173693+00:00","generated_at":"2026-06-21T06:07:13.965948+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Galera submits NDA for avasopasem to reduce severe oral mucositis in head & neck cancer","bullets":["NDA for avasopasem submitted to FDA for radiotherapy-induced severe oral mucositis (SOM) in head/neck cancer.","Two positive placebo-controlled trials (Phase 3 ROMAN, Phase 2b GT-201) enrolled 678 patients total.","ROMAN trial: statistically significant reduction in SOM incidence; median SOM days more than halved vs placebo.","Prospectively defined analysis showed avasopasem reduced cisplatin-related chronic kidney disease by 50%.","FDA previously granted Fast Track and Breakthrough Therapy designations; no approved SOM drug currently exists."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-302295","json":"https://secwatch.observer/filing/0001193125-22-302295.json","markdown":"https://secwatch.observer/filing/0001193125-22-302295.md","text":"https://secwatch.observer/filing/0001193125-22-302295.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1563577/000119312522302295/0001193125-22-302295-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1563577/000119312522302295/d371259d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T06:07:13.965948+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"}