{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-022736","form_type":"8-K","ticker":"ETON","cik":"0001710340","company_name":"Eton Pharmaceuticals, Inc.","filed_at":"2024-07-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:14.207313+00:00","generated_at":"2026-05-31T20:43:13.238732+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Eton Pharmaceuticals FDA accepts NDA for ET-400 (hydrocortisone oral solution); PDUFA Feb 28, 2025","bullets":["PDUFA target action date set for February 28, 2025.","ET-400 is a proprietary room-temperature stable hydrocortisone oral solution with patent protection through 2043.","CEO Sean Brynjelsen projects combined peak sales of ET-400 and ALKINDI SPRINKLE to exceed $50 million annually.","Company preparing for potential product launch in early 2025 upon FDA approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-022736","json":"https://secwatch.observer/filing/0001437749-24-022736.json","markdown":"https://secwatch.observer/filing/0001437749-24-022736.md","text":"https://secwatch.observer/filing/0001437749-24-022736.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710340/000143774924022736/0001437749-24-022736-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710340/000143774924022736/eton20240708_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T20:43:13.238732+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"}