{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-029747","form_type":"8-K","ticker":"ZVRA","cik":"0001434647","company_name":"ZEVRA THERAPEUTICS, INC.","filed_at":"2024-09-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.053131+00:00","generated_at":"2026-05-31T02:46:10.926269+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Zevra Therapeutics' MIPLYFFA receives FDA approval as first treatment for Niemann-Pick disease type C","bullets":["FDA approved MIPLYFFA (arimoclomol) for NPC in adult and pediatric patients 2 years+; first FDA-approved NPC treatment.","MIPLYFFA is indicated for use in combination with miglustat for neurological manifestations of NPC.","Zevra received a rare pediatric disease priority review voucher (PRV) with the approval.","Launch of AmplifyAssist patient support program; MIPLYFFA expected commercially available in 8-12 weeks.","Conference call and webcast on Sept 23, 2024 at 8 a.m. ET to discuss approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-029747","json":"https://secwatch.observer/filing/0001437749-24-029747.json","markdown":"https://secwatch.observer/filing/0001437749-24-029747.md","text":"https://secwatch.observer/filing/0001437749-24-029747.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1434647/000143774924029747/0001437749-24-029747-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1434647/000143774924029747/zvra20240920_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T02:46:10.926269+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"}