{"schema_version":"secwatch.filing_event.v1","accession":"0001558370-22-017549","form_type":"8-K","ticker":"PLX","cik":"0001006281","company_name":"Protalix BioTherapeutics, Inc.","filed_at":"2022-11-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:49.193496+00:00","generated_at":"2026-06-21T19:13:13.422855+00:00","sec_items":["2.02","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Protalix resubmits BLA for PRX-102 for Fabry disease; Q3 revenue up 96% YoY","bullets":["BLA resubmitted to FDA on Nov 9, 2022; FDA review expected within six months; milestone payment due upon approval.","Q3 2022 revenue from selling goods $8.8M up 96% YoY; net loss $3.6M ($0.07/share) vs loss $4.2M ($0.09).","Cash and equivalents $20.8M as of Sep 30, 2022.","BLA includes data from over 140 patients, phase III BALANCE, BRIDGE, BRIGHT studies, and phase I/II extension.","Chiesi Global Rare Diseases is commercialization partner; EMA also reviewing MAA for PRX-102."],"urls":{"canonical":"https://secwatch.observer/filing/0001558370-22-017549","json":"https://secwatch.observer/filing/0001558370-22-017549.json","markdown":"https://secwatch.observer/filing/0001558370-22-017549.md","text":"https://secwatch.observer/filing/0001558370-22-017549.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/0001558370-22-017549-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/plx-20221109x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T19:13:13.422855+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":[{"claim_id":"c76b7094eee0293d08254e3cbb80ef5a405f6d04","claim":"Protalix BioTherapeutics, Inc. reported financial results for the third quarter ended September 30, 2022.","evidence_excerpt":"On November 14, 2022, Protalix BioTherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2022 and provided a business update on recent corporate and regulatory developments.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1006281/000155837022017549/0001558370-22-017549-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"the third quarter ended September 30, 2022"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}