{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-23-035343","form_type":"8-K","ticker":"ZVRA","cik":"0001434647","company_name":"ZEVRA THERAPEUTICS, INC.","filed_at":"2023-12-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:29.069873+00:00","generated_at":"2026-06-07T06:51:38.239233+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Zevra resubmits NDA for arimoclomol (NPC) to FDA on Dec 22, 2023","bullets":["FDA acknowledgment letter and PDUFA date expected within 30 days.","Resubmission classified as Class II; review targeted within six months.","Additional data includes non-clinical studies, natural history, real-world data, and 4-year open-label extension results.","Open-label extension data suggests arimoclomol reduces long-term NPC progression.","Arimoclomol evaluated in 21 studies across 600+ subjects."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-23-035343","json":"https://secwatch.observer/filing/0001437749-23-035343.json","markdown":"https://secwatch.observer/filing/0001437749-23-035343.md","text":"https://secwatch.observer/filing/0001437749-23-035343.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1434647/000143774923035343/0001437749-23-035343-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1434647/000143774923035343/zvra20231226_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T06:51:38.239233+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"}