{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-000393","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2026-01-05T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.388692+00:00","generated_at":"2026-05-16T11:36:50.218361+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Protalix provides business update; PRX-115 Phase 2 IND effective, gout market focus","bullets":["PRX-115 Phase 1 data show rapid, durable urate lowering lasting 12 weeks at higher doses; Phase 2 IND effective.","Fabry drug Elfabrio launched through Chiesi; CHMP negative opinion on E4W dosing under appeal, outcome Q1 2026.","Fabry market projected $3.4B by 2030; Elfabrio target capture 15-20% share.","Elelyso revenue continues via Pfizer and Fiocruz partnerships.","New renal pipeline includes PRX-119 (long-acting DNase I) and Secarna RNA collaboration."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-000393","json":"https://secwatch.observer/filing/0001104659-26-000393.json","markdown":"https://secwatch.observer/filing/0001104659-26-000393.md","text":"https://secwatch.observer/filing/0001104659-26-000393.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000110465926000393/0001104659-26-000393-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000110465926000393/plx-20260105x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T11:36:50.218361+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"}