{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-101269","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2025-10-21T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.104719+00:00","generated_at":"2026-05-17T03:02:38.054644+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Quoin Pharmaceuticals receives FDA Orphan Drug Designation for QRX003 in Netherton Syndrome","bullets":["FDA grants Orphan Drug Designation to QRX003 for Netherton Syndrome; 7-year US exclusivity if approved.","Designation follows EMA Orphan Drug Designation granted in May 2025.","Two pivotal trials ongoing; enrollment completion expected Q1 2026, top-line data H2 2026, NDA submission later 2026.","QRX003 on track to become first approved treatment for Netherton Syndrome."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-101269","json":"https://secwatch.observer/filing/0001104659-25-101269.json","markdown":"https://secwatch.observer/filing/0001104659-25-101269.md","text":"https://secwatch.observer/filing/0001104659-25-101269.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465925101269/0001104659-25-101269-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465925101269/tm2529207d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:02:38.054644+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"}