{"filing":{"accession_number":"0001104659-26-106705","cik":"0001671502","ticker":"QNRX","company_name":"Quoin Pharmaceuticals Ltd.","form":"8-K","filing_date":"2026-09-10","report_date":"2026-09-08","primary_document":"tm2625203d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1671502/000110465926106705/tm2625203d1_8k.htm"},"events":[{"id":32639,"run_id":30001,"accession_number":"0001104659-26-106705","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.8,"summary":"The FDA granted Rare Pediatric Disease (RPD) Designation for QRX003 in Peeling Skin Syndrome, marking the second such designation for this asset. This regulatory milestone advances the company's clinical development program and qualifies the company for a potential Priority Review Voucher upon NDA approval, which has significant commercial value.","company_name":"Quoin Pharmaceuticals Ltd.","ticker":"QNRX","filing_date":"2026-09-10","form":"8-K","submitted_at":null,"items":[{"id":35859,"accession_number":"0001104659-26-106705","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 grant of Rare Pediatric Disease (RPD) Designation for QRX003 in Peeling Skin Syndrome, the second such designation for this asset. This is a regulatory milestone that advances the company's clinical development program and qualifies the company for a potential Priority Review Voucher upon NDA approval. While this is a positive operational/regulatory development for a clinical-stage biotech company, it does not fit neatly into the specific event categories (e.g., it is not a material impairment, covenant breach, or M\u0026A activity), making it an operational milestone best classified as operational_other.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-10T20:09:38.115887+00:00","company_name":"","ticker":null,"filing_date":""},{"id":35861,"accession_number":"0001104659-26-106705","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"The FDA's grant of Rare Pediatric Disease (RPD) Designation for QRX003 in Peeling Skin Syndrome is a material regulatory milestone that advances the company's clinical development strategy. The designation is the second RPD granted for QRX003 and qualifies the company for a potential Priority Review Voucher (PRV) upon NDA approval, which has significant commercial value. This is a strategic operational/regulatory achievement that would affect a reasonable investor's assessment of the company's pipeline progress and market opportunity, but does not fit the specific categories of earnings release, M\u0026A activity, impairment, or other named event types.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-10T20:09:38.115887+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":35859,"accession_number":"0001104659-26-106705","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 grant of Rare Pediatric Disease (RPD) Designation for QRX003 in Peeling Skin Syndrome, the second such designation for this asset. This is a regulatory milestone that advances the company's clinical development program and qualifies the company for a potential Priority Review Voucher upon NDA approval. While this is a positive operational/regulatory development for a clinical-stage biotech company, it does not fit neatly into the specific event categories (e.g., it is not a material impairment, covenant breach, or M\u0026A activity), making it an operational milestone best classified as operational_other.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-10T20:09:38.115887+00:00","company_name":"Quoin Pharmaceuticals Ltd.","ticker":"QNRX","filing_date":"2026-09-10"},{"id":35861,"accession_number":"0001104659-26-106705","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"reasoning":"The FDA's grant of Rare Pediatric Disease (RPD) Designation for QRX003 in Peeling Skin Syndrome is a material regulatory milestone that advances the company's clinical development strategy. The designation is the second RPD granted for QRX003 and qualifies the company for a potential Priority Review Voucher (PRV) upon NDA approval, which has significant commercial value. This is a strategic operational/regulatory achievement that would affect a reasonable investor's assessment of the company's pipeline progress and market opportunity, but does not fit the specific categories of earnings release, M\u0026A activity, impairment, or other named event types.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-09-10T20:09:38.115887+00:00","company_name":"Quoin Pharmaceuticals Ltd.","ticker":"QNRX","filing_date":"2026-09-10"}]}