{"filing":{"accession_number":"0001104659-26-109639","cik":"0001671502","ticker":"QNRX","company_name":"Quoin Pharmaceuticals Ltd.","form":"8-K","filing_date":"2026-09-22","report_date":"2026-09-22","primary_document":"tm2625948d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926109639/tm2625948d1_8k.htm"},"events":[{"id":34324,"run_id":31588,"accession_number":"0001104659-26-109639","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.82,"summary":"Quoin Pharmaceuticals announced that the FDA granted Fast Track Designation for QRX003 in Peeling Skin Syndrome, marking the first-ever Fast Track Designation for this indication and the second for the drug overall. This regulatory milestone facilitates development and expedites FDA review, materially advancing the company's clinical development program and regulatory pathway.","company_name":"Quoin Pharmaceuticals Ltd.","ticker":"QNRX","filing_date":"2026-09-22","form":"8-K","submitted_at":null,"items":[{"id":38016,"accession_number":"0001104659-26-109639","item_number":"7.01","item_title":"Regulation","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA Fast Track Designation for QRX003 in Peeling Skin Syndrome, a significant regulatory milestone for a late-stage specialty pharmaceutical company. This is a material operational/strategic event—the first Fast Track Designation for any PSS therapy and the second for QRX003 overall—that facilitates development and expedites regulatory review. While not a specific named event type (e.g., earnings, M\u0026A, or litigation), it is clearly operational and material to investors assessing the company's pipeline progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-22T20:19:48.262239+00:00","company_name":"","ticker":null,"filing_date":""},{"id":38018,"accession_number":"0001104659-26-109639","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA Fast Track Designation for QRX003 in Peeling Skin Syndrome, the second Fast Track Designation for this asset. This is a regulatory milestone that advances the company's clinical development program and facilitates FDA interactions, but it is not a completed clinical trial result, a material impairment, a going-concern issue, or an executive/governance event. The designation is a material operational/regulatory achievement for a late-stage specialty pharma company, warranting classification as an operational milestone rather than a more specific financial or governance category.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-22T20:19:48.262239+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":38016,"accession_number":"0001104659-26-109639","item_number":"7.01","item_title":"Regulation","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA Fast Track Designation for QRX003 in Peeling Skin Syndrome, a significant regulatory milestone for a late-stage specialty pharmaceutical company. This is a material operational/strategic event—the first Fast Track Designation for any PSS therapy and the second for QRX003 overall—that facilitates development and expedites regulatory review. While not a specific named event type (e.g., earnings, M\u0026A, or litigation), it is clearly operational and material to investors assessing the company's pipeline progress and regulatory pathway.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-22T20:19:48.262239+00:00","company_name":"Quoin Pharmaceuticals Ltd.","ticker":"QNRX","filing_date":"2026-09-22"},{"id":38018,"accession_number":"0001104659-26-109639","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The disclosure announces FDA Fast Track Designation for QRX003 in Peeling Skin Syndrome, the second Fast Track Designation for this asset. This is a regulatory milestone that advances the company's clinical development program and facilitates FDA interactions, but it is not a completed clinical trial result, a material impairment, a going-concern issue, or an executive/governance event. The designation is a material operational/regulatory achievement for a late-stage specialty pharma company, warranting classification as an operational milestone rather than a more specific financial or governance category.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-22T20:19:48.262239+00:00","company_name":"Quoin Pharmaceuticals Ltd.","ticker":"QNRX","filing_date":"2026-09-22"}]}