{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-024975","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2026-03-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.389062+00:00","generated_at":"2026-05-15T17:26:24.899059+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"EC approves Elfabrio every-4-weeks dosing; Protalix gets $25M milestone","bullets":["European Commission approved 2 mg/kg every-4-weeks regimen for Elfabrio in stable adult Fabry patients.","Decision follows positive CHMP opinion; dosing reduces infusion frequency from every-2-weeks.","Protalix entitled to a $25 million regulatory milestone payment from Chiesi upon EC approval.","US FDA-approved dosing remains 1 mg/kg every 2 weeks; not affected by EU decision.","BRIGHT study (PB-102-F50) and extension study supported the alternative dosing regimen."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-024975","json":"https://secwatch.observer/filing/0001104659-26-024975.json","markdown":"https://secwatch.observer/filing/0001104659-26-024975.md","text":"https://secwatch.observer/filing/0001104659-26-024975.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000110465926024975/0001104659-26-024975-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000110465926024975/plx-20260309x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T17:26:24.899059+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"}