{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-25-052062","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2025-05-23T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.280021+00:00","generated_at":"2026-05-20T14:32:22.461471+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Quoin Pharma gets FDA clearance to start second pivotal Netherton Syndrome study for QRX003","bullets":["FDA cleared Study CL-QRX003-002, testing whole-body QRX003 (~80% BSA) with off-label systemic therapy in ~12-15 subjects.","Complements monotherapy pivotal study CL-QRX003-003 led by Dr. Amy Paller at Northwestern with up to 6 international sites.","Five U.S. sites open; sixth expected in June; all sites have subject cohorts ready for rapid enrollment.","Targets full recruitment into both pivotal studies by Q1 2026 and NDA filing later in 2026.","Quoin claims only company running two late-stage whole-body pivotal NS studies."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-25-052062","json":"https://secwatch.observer/filing/0001104659-25-052062.json","markdown":"https://secwatch.observer/filing/0001104659-25-052062.md","text":"https://secwatch.observer/filing/0001104659-25-052062.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465925052062/0001104659-25-052062-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465925052062/tm2516001d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T14:32:22.461471+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"}