{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-002935","form_type":"8-K","ticker":"ETON","cik":"0001710340","company_name":"Eton Pharmaceuticals, Inc.","filed_at":"2025-02-06T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.534885+00:00","generated_at":"2026-05-27T01:42:25.040427+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"FDA extends PDUFA date for Eton's ET-400 NDA to May 28, 2025","bullets":["Original PDUFA date Feb 28, 2025 extended 3 months to May 28, 2025 for FDA review of supplemental info submitted Dec 2024.","Eton states it has fully addressed all FDA questions and there are no outstanding requests.","CEO says standard extension will not significantly affect internal 2025 revenue projections; company remains confident."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-002935","json":"https://secwatch.observer/filing/0001437749-25-002935.json","markdown":"https://secwatch.observer/filing/0001437749-25-002935.md","text":"https://secwatch.observer/filing/0001437749-25-002935.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925002935/0001437749-25-002935-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925002935/eton20250205_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T01:42:25.040427+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"}