{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-005127","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2026-01-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.839513+00:00","generated_at":"2026-05-16T09:33:44.351680+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Quoin seeks SFDA breakthrough designation; QRX003 could be first approved Netherton treatment in 2H2026","bullets":["Filed application with Saudi FDA for Breakthrough Medicine Designation for QRX003 for Netherton Syndrome.","If granted, QRX003 could be approved for sale/reimbursement in Saudi Arabia by 2H 2026, first-ever approved treatment for Netherton Syndrome.","Two pivotal trials for QRX003 lotion (4%) enrollment expected to complete 1H 2026; top-line data in 2H 2026.","NDA submission planned in US and other territories in late 2026/early 2027, subject to clinical outcomes.","As of Jan 20, 2026, Quoin has 1,616,179 ADSs outstanding."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-005127","json":"https://secwatch.observer/filing/0001104659-26-005127.json","markdown":"https://secwatch.observer/filing/0001104659-26-005127.md","text":"https://secwatch.observer/filing/0001104659-26-005127.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926005127/0001104659-26-005127-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926005127/tm263667d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T09:33:44.351680+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"}