{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-008953","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2023-05-10T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.556575+00:00","generated_at":"2026-06-15T05:39:44.727100+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves Protalix/Chiesi's ELFABRIO for Fabry disease in adults","bullets":["FDA approved ELFABRIO (pegunigalsidase alfa-iwxj) for adult Fabry disease patients.","ELFABRIO is a PEGylated enzyme replacement therapy with a half-life of 78.9 ± 10.3 hours.","More than 140 patients studied; head-to-head trial showed non-inferior efficacy to agalsidase beta in controlling eGFR decline.","Most common adverse reactions (≥15%): infusion reactions, nasopharyngitis, headache, diarrhea, fatigue, nausea, back pain, pain in extremity, sinusitis.","Protalix CEO says approval is a testament to team dedication; Chiesi offers alternative treatment option."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-008953","json":"https://secwatch.observer/filing/0001558370-23-008953.json","markdown":"https://secwatch.observer/filing/0001558370-23-008953.md","text":"https://secwatch.observer/filing/0001558370-23-008953.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023008953/0001558370-23-008953-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023008953/plx-20230510x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-15T05:39:44.727100+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"}