{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-013227","form_type":"8-K","ticker":"ETON","cik":"0001710340","company_name":"Eton Pharmaceuticals, Inc.","filed_at":"2025-04-28T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.423477+00:00","generated_at":"2026-05-23T05:03:32.257704+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Eton Pharmaceuticals submits NDA for ET-600 (desmopressin oral solution) for central diabetes insipidus","bullets":["FDA NDA submission for ET-600, a proprietary oral solution of desmopressin for central diabetes insipidus.","Expected 10-month FDA review; potential approval and launch in Q1 2026.","Patent expires in 2044; bioequivalence study in 75 subjects demonstrated PK equivalence to reference product.","Estimated 3,000 pediatric patients in the U.S. with central diabetes insipidus.","Pre-launch commercial activities underway; CEO cites strong physician demand for titratable pediatric dosing."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-013227","json":"https://secwatch.observer/filing/0001437749-25-013227.json","markdown":"https://secwatch.observer/filing/0001437749-25-013227.md","text":"https://secwatch.observer/filing/0001437749-25-013227.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925013227/0001437749-25-013227-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925013227/eton20250326_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T05:03:32.257704+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"}