{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-100264","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2025-10-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:38.498461+00:00","generated_at":"2026-05-17T03:20:31.084519+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Protalix and Chiesi receive CHMP negative opinion on every-4-week dosing for Elfabrio in EU","bullets":["CHMP issued negative opinion for 2 mg/kg every 4 weeks dosing of Elfabrio (pegunigalsidase alfa) for Fabry disease.","Currently approved dosing regimen of 1 mg/kg every 2 weeks remains unchanged in the EU.","Decision based on BRIGHT trial and modeling; data insufficient to conclude similar efficacy.","Chiesi and Protalix express disappointment but reaffirm commitment to Fabry community.","No financial guidance or other material impact disclosed in the filing."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-100264","json":"https://secwatch.observer/filing/0001104659-25-100264.json","markdown":"https://secwatch.observer/filing/0001104659-25-100264.md","text":"https://secwatch.observer/filing/0001104659-25-100264.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000110465925100264/0001104659-25-100264-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000110465925100264/plx-20251017x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:20:31.084519+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"}