{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-051324","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2025-05-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.279775+00:00","generated_at":"2026-05-20T22:36:12.650156+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Quoin Pharma gets EMA Orphan Drug Designation for QRX003 for Netherton Syndrome","bullets":["EMA grants Orphan Drug Designation for QRX003, a topical treatment for Netherton Syndrome, a rare disease with no approved therapies.","ODD provides 10 years of market exclusivity in Europe upon approval, plus fee reductions and access to EU grants.","QRX003 is in multiple late-stage clinical trials; CEO cites skin healing and pruritus elimination in pediatric study."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-051324","json":"https://secwatch.observer/filing/0001104659-25-051324.json","markdown":"https://secwatch.observer/filing/0001104659-25-051324.md","text":"https://secwatch.observer/filing/0001104659-25-051324.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465925051324/0001104659-25-051324-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465925051324/tm2515741d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T22:36:12.650156+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"}