{"filing":{"accession_number":"0001104659-26-092246","cik":"0001737953","ticker":"REPL","company_name":"Replimune Group, Inc.","form":"8-K","filing_date":"2026-08-07","report_date":"2026-08-06","primary_document":"tm2622487d1_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1737953/000110465926092246/tm2622487d1_8k.htm"},"events":[{"id":26066,"run_id":23675,"accession_number":"0001104659-26-092246","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for unresectable advanced cutaneous melanoma after anti-PD-1 progression. This is a major regulatory milestone and product approval that materially advances the company's commercial prospects. While this is a regulatory achievement, it is fundamentally an operational/commercial milestone—the company's first approved product reaching the market—rather than fitting the specific financial, governance, or legal event categories. The approval is material to investors as it represents validation of the company's lead therapeutic candidate and opens a revenue-generating opportunity.","company_name":"Replimune Group, Inc.","ticker":"REPL","filing_date":"2026-08-07","form":"8-K","submitted_at":null,"items":[{"id":27065,"accession_number":"0001104659-26-092246","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for unresectable advanced cutaneous melanoma after anti-PD-1 progression. This is a major regulatory milestone and product approval that materially advances the company's commercial prospects. While this is a regulatory achievement, it is fundamentally an operational/commercial milestone—the company's first approved product reaching the market—rather than fitting the specific financial, governance, or legal event categories. The approval is material to investors as it represents validation of the company's lead therapeutic candidate and opens a revenue-generating opportunity.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-09T03:03:20.570329+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":27065,"accession_number":"0001104659-26-092246","item_number":"8.01","item_title":null,"event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for unresectable advanced cutaneous melanoma after anti-PD-1 progression. This is a major regulatory milestone and product approval that materially advances the company's commercial prospects. While this is a regulatory achievement, it is fundamentally an operational/commercial milestone—the company's first approved product reaching the market—rather than fitting the specific financial, governance, or legal event categories. The approval is material to investors as it represents validation of the company's lead therapeutic candidate and opens a revenue-generating opportunity.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-09T03:03:20.570329+00:00","company_name":"Replimune Group, Inc.","ticker":"REPL","filing_date":"2026-08-07"}]}