{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-018698","form_type":"8-K","ticker":"ETON","cik":"0001710340","company_name":"Eton Pharmaceuticals, Inc.","filed_at":"2025-05-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.423868+00:00","generated_at":"2026-05-20T08:19:42.186591+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Eton Pharma gets FDA approval for KHINDIVI oral solution; peak sales >$50M","bullets":["KHINDIVI is the first and only FDA-approved hydrocortisone oral solution for pediatric adrenocortical insufficiency.","Commercial launch expected week of June 2, 2025; product distributed through Anovo specialty pharmacy.","Combined peak sales of KHINDIVI and ALKINDI SPRINKLE expected to exceed $50 million per year.","Indicated for patients 5 years and older; eliminates need to split or crush tablets for accurate dosing.","Eton's rare disease sales team to promote alongside ALKINDI SPRINKLE; Eton Cares program offers $0 co-pay for qualifying patients."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-018698","json":"https://secwatch.observer/filing/0001437749-25-018698.json","markdown":"https://secwatch.observer/filing/0001437749-25-018698.md","text":"https://secwatch.observer/filing/0001437749-25-018698.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925018698/0001437749-25-018698-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925018698/eton20250522_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T08:19:42.186591+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"}