{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-115709","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2026-10-14T10:35:34+00:00","discovered_at":"2026-10-14T10:40:00.304294+00:00","generated_at":"2026-10-14T10:40:03.084397+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Quoin's QRX003 wins EMA Orphan Drug Designation for Peeling Skin Syndrome","bullets":["EMA granted Orphan Drug Designation to lead candidate QRX003 for Peeling Skin Syndrome on Oct 14, 2026, giving 10 years of EU market exclusivity if approved.","Quoin says it is on track to initiate the first-ever formal clinical study in Peeling Skin Syndrome before year end.","Designation is the eighth regulatory milestone for QRX003, which also holds US FDA Pediatric Rare Disease and Fast Track designations for the indication.","QRX003 also has Orphan Drug Designation in the US, Europe and Japan for Netherton Syndrome, where it is in late-stage trials and no therapies are approved."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-115709","json":"https://secwatch.observer/filing/0001104659-26-115709.json","markdown":"https://secwatch.observer/filing/0001104659-26-115709.md","text":"https://secwatch.observer/filing/0001104659-26-115709.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/0001104659-26-115709-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926115709/tm2627548d1_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-14T10:40:03.084397+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"}