{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-013838","form_type":"8-K","ticker":"ETON","cik":"0001710340","company_name":"Eton Pharmaceuticals, Inc.","filed_at":"2024-04-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:19.691286+00:00","generated_at":"2026-06-03T04:34:18.841593+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 submits NDA to FDA for ET-400 hydrocortisone oral solution; approval expected Q1 2025","bullets":["NDA submitted for ET-400, a proprietary patented hydrocortisone oral solution.","Company expects 10-month FDA review; potential approval and launch in Q1 2025.","Combined peak sales of ET-400 and Alkindi Sprinkle forecast to exceed $50M annually.","ET-400 has patent protection through 2043; additional patent applications under review."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-013838","json":"https://secwatch.observer/filing/0001437749-24-013838.json","markdown":"https://secwatch.observer/filing/0001437749-24-013838.md","text":"https://secwatch.observer/filing/0001437749-24-013838.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710340/000143774924013838/0001437749-24-013838-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710340/000143774924013838/eton20240426c_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-03T04:34:18.841593+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"}