{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-25-007615","form_type":"8-K","ticker":"ETON","cik":"0001710340","company_name":"Eton Pharmaceuticals, Inc.","filed_at":"2025-03-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:04.535625+00:00","generated_at":"2026-05-24T18:38:35.754723+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.72,"calibrated_materiality_score":0.72,"confidence":"high","headline":"ET-600 passes pivotal bioequivalence study; NDA submission expected April 2025","bullets":["ET-600 (desmopressin oral solution) met primary endpoint in pivotal bioequivalence study of 75 healthy subjects.","Company expects to submit NDA to FDA in April 2025; if approved, would be only FDA-approved oral liquid desmopressin.","CEO Brynjelsen anticipates potential product launch in Q1 2026; pre-launch commercial activities underway.","ET-600 is a proprietary patented formulation for central diabetes insipidus targeting precise pediatric dosing."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-25-007615","json":"https://secwatch.observer/filing/0001437749-25-007615.json","markdown":"https://secwatch.observer/filing/0001437749-25-007615.md","text":"https://secwatch.observer/filing/0001437749-25-007615.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925007615/0001437749-25-007615-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1710340/000143774925007615/eton20250312_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-24T18:38:35.754723+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"}