{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-23-126974","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2023-12-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:30.010010+00:00","generated_at":"2026-06-07T11:20:11.108880+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Quoin receives FDA clearance to expand QRX003 trials; blinded trial to 30 subjects, dose changed to 4% twice daily","bullets":["FDA cleared protocol amendments for both ongoing QRX003 trials for Netherton Syndrome.","Blinded trial increased from 18 to 30 subjects; lower 2% dose eliminated, all now receive 4% QRX003 or placebo twice daily.","Open-label trial expanded from 10 to 20 subjects; dosing frequency changed to twice daily with continued off-label systemic therapy.","Decision based on positive initial data and clean safety profile; all clinical endpoints unchanged.","Quoin plans to open additional clinical sites to accommodate increased enrollment."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-23-126974","json":"https://secwatch.observer/filing/0001104659-23-126974.json","markdown":"https://secwatch.observer/filing/0001104659-23-126974.md","text":"https://secwatch.observer/filing/0001104659-23-126974.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465923126974/0001104659-23-126974-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465923126974/tm2333160d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T11:20:11.108880+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"}