{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-008188","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2023-05-05T23:59:59+00:00","discovered_at":"2026-05-14T18:03:37.556279+00:00","generated_at":"2026-06-15T15:34:51.021047+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"European Commission approves Protalix's PRX-102 for Fabry disease in EU","bullets":["EC granted marketing authorization to PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.","Approval based on clinical program in >140 patients with up to 7.5 years of treatment.","PRX-102 showed non-inferior efficacy to agalsidase beta in controlling kidney disease (eGFR decline).","PRX-102 is not yet approved by FDA; U.S. review ongoing.","Partner Chiesi Global Rare Diseases will commercialize in the EU."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-008188","json":"https://secwatch.observer/filing/0001558370-23-008188.json","markdown":"https://secwatch.observer/filing/0001558370-23-008188.md","text":"https://secwatch.observer/filing/0001558370-23-008188.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023008188/0001558370-23-008188-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023008188/plx-20230505x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-15T15:34:51.021047+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"}