{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-109639","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2026-09-22T20:15:34+00:00","discovered_at":"2026-09-22T20:18:00.334114+00:00","generated_at":"2026-09-22T20:18:21.676449+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":"FDA grants Fast Track to Quoin's QRX003 for Peeling Skin Syndrome","bullets":["FDA granted Fast Track Designation to QRX003 for Peeling Skin Syndrome (PSS) on Sept 22, 2026.","First-ever Fast Track for a PSS therapy; second Fast Track for QRX003 (prior: Netherton Syndrome).","Follows July 2026 FDA clearance of first-ever IND for PSS; Phase 2/3 study planned 2H 2026.","Phase 2/3 to enroll up to 12 pediatric/adult patients; targeting 2028 approval; no approved PSS treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-109639","json":"https://secwatch.observer/filing/0001104659-26-109639.json","markdown":"https://secwatch.observer/filing/0001104659-26-109639.md","text":"https://secwatch.observer/filing/0001104659-26-109639.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926109639/0001104659-26-109639-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926109639/tm2625948d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-22T20:18:21.676449+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"}