{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-076822","form_type":"8-K","ticker":"QNRX","cik":"0001671502","company_name":"Quoin Pharmaceuticals, Ltd.","filed_at":"2026-06-23T20:15:28+00:00","discovered_at":"2026-06-23T20:17:00.304381+00:00","generated_at":"2026-06-23T20:17:44.877947+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Quoin Pharma gets FDA conditional approval of brand name QYLEKI for Netherton Syndrome candidate","bullets":["FDA conditionally approved QYLEKI as proposed brand name for QRX003, an investigational treatment for Netherton Syndrome.","No approved treatment currently exists; QRX003 could become the first if approved.","Pivotal Phase 3 study expected to initiate in H2 2026; potential NDA filing in 2027.","QRX003 holds Orphan Drug Designations in US, EU, Japan; Fast Track and Rare Pediatric Disease Designations from FDA.","Positive clinical update from ongoing Pediatric Compassionate Use Program released June 16, 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-076822","json":"https://secwatch.observer/filing/0001104659-26-076822.json","markdown":"https://secwatch.observer/filing/0001104659-26-076822.md","text":"https://secwatch.observer/filing/0001104659-26-076822.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926076822/0001104659-26-076822-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926076822/tm2618505d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-23T20:17:44.877947+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"}