{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-106705","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2026-09-10T20:05:43+00:00","discovered_at":"2026-09-10T20:07:19.612575+00:00","generated_at":"2026-09-10T20:07:31.740767+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"FDA grants Rare Pediatric Disease Designation for QRX003 in Peeling Skin Syndrome","bullets":["Second RPD designation for QRX003; first was for Netherton Syndrome.","If NDA approved, Quoin may receive a Priority Review Voucher (PRV), which can be sold or transferred.","Phase 2 study expected to initiate in 2H 2026, enrolling up to 12 pediatric and adult PSS patients in U.S. and Europe.","No approved treatments currently exist for Peeling Skin Syndrome."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-106705","json":"https://secwatch.observer/filing/0001104659-26-106705.json","markdown":"https://secwatch.observer/filing/0001104659-26-106705.md","text":"https://secwatch.observer/filing/0001104659-26-106705.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926106705/0001104659-26-106705-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926106705/tm2625203d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-10T20:07:31.740767+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"}