{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-010565","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2023-05-30T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.557197+00:00","generated_at":"2026-06-14T11:04:13.923818+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Protalix announces FDA and EU approval of Elfabrio for Fabry disease; investor event June 27","bullets":["Elfabrio (pegunigalsidase alfa) approved in both US and EU for adult Fabry disease patients.","Commercial partner Chiesi Global Rare Diseases is prepared for launch.","In-person investor event scheduled for June 27, 2023 at Lotte Palace Hotel, New York City.","CEO Dror Bashan highlights ProCellEx platform and pipeline programs for future growth."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-010565","json":"https://secwatch.observer/filing/0001558370-23-010565.json","markdown":"https://secwatch.observer/filing/0001558370-23-010565.md","text":"https://secwatch.observer/filing/0001558370-23-010565.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023010565/0001558370-23-010565-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023010565/plx-20230530x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-14T11:04:13.923818+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"}