{"filing":{"accession_number":"0001104659-26-081562","cik":"0001567892","ticker":null,"company_name":"Keenova Therapeutics plc","form":"8-K","filing_date":"2026-07-08","report_date":null,"primary_document":"tm2619951d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1567892/000110465926081562/tm2619951d1_8k.htm"},"events":[{"id":16597,"run_id":14829,"accession_number":"0001104659-26-081562","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.85,"summary":"Keenova announced positive Phase 3 clinical trial results for XIAFLEX in treating plantar fibromatosis, meeting its primary endpoint of pain reduction and key secondary endpoints of functional improvement. 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