{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-24-006365","form_type":"8-K","ticker":"ZVRA","cik":"0001434647","company_name":"ZEVRA THERAPEUTICS, INC.","filed_at":"2024-03-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.179346+00:00","generated_at":"2026-06-05T04:40:11.095680+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA extends arimoclomol review; new PDUFA date Sept 21, 2024","bullets":["FDA extended review of arimoclomol NDA for Niemann-Pick disease type C; new PDUFA action date Sept 21, 2024 (was June 21, 2024).","FDA determined additional analyses submitted by Zevra constitute a Major Amendment, causing the extension.","FDA reaffirmed intent to present the resubmission at an advisory committee meeting to be scheduled.","CEO McFarlane notes NPC patient advocacy petition; early access program continues.","Zevra previously announced acceptance of NDA resubmission in early January 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-24-006365","json":"https://secwatch.observer/filing/0001437749-24-006365.json","markdown":"https://secwatch.observer/filing/0001437749-24-006365.md","text":"https://secwatch.observer/filing/0001437749-24-006365.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1434647/000143774924006365/0001437749-24-006365-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1434647/000143774924006365/zvra20240303_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-05T04:40:11.095680+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"}