{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-23-001975","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2023-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:03:43.447462+00:00","generated_at":"2026-06-19T00:22:20.759593+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":"Protalix and Chiesi receive positive CHMP opinion for PRX-102 (pegunigalsidase alfa) for Fabry disease","bullets":["CHMP adopted positive opinion recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for adult Fabry disease patients.","PRX-102 is the first and only pegylated enzyme replacement therapy for Fabry disease.","Clinical program includes Phase 3 BALANCE, BRIDGE, BRIGHT trials with over 400 years of exposure.","Final European Commission decision on MAA expected in early May 2023.","Protalix (PLX) and Chiesi Global Rare Diseases (Chiesi Group) collaboration."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-23-001975","json":"https://secwatch.observer/filing/0001558370-23-001975.json","markdown":"https://secwatch.observer/filing/0001558370-23-001975.md","text":"https://secwatch.observer/filing/0001558370-23-001975.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023001975/0001558370-23-001975-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000155837023001975/plx-20230224x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-19T00:22:20.759593+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"}