{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-105594","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2025-11-03T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.498846+00:00","generated_at":"2026-05-17T00:48:34.771967+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Protalix and Chiesi request re-examination of negative EMA opinion on Elfabrio E4W dosing regimen","bullets":["CHMP issued negative opinion on Elfabrio 2 mg/kg every-4-weeks dosing regimen; re-examination requested.","Existing EU marketing authorization for every-2-weeks regimen remains in effect pending outcome.","Approved E2W dosing regimen unchanged; companies committed to addressing Fabry community needs.","Re-examination process underway; timeline for final EC decision not disclosed."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-105594","json":"https://secwatch.observer/filing/0001104659-25-105594.json","markdown":"https://secwatch.observer/filing/0001104659-25-105594.md","text":"https://secwatch.observer/filing/0001104659-25-105594.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000110465925105594/0001104659-25-105594-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000110465925105594/plx-20251103x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T00:48:34.771967+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"}