{"filing":{"accession_number":"0001193125-26-295539","cik":"0001832038","ticker":"IVVD","company_name":"Invivyd, Inc.","form":"8-K","filing_date":"2026-07-06","report_date":null,"primary_document":"ivvd-20260706.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1832038/000119312526295539/ivvd-20260706.htm"},"events":[{"id":16102,"run_id":14369,"accession_number":"0001193125-26-295539","anchor_item_number":"8.01","event_type":"legal_other","event_domain":"legal","is_material":true,"confidence":0.85,"summary":"Invivyd received a Notice of Termination of the Emergency Use Authorization (EUA) for PEMGARDA from the FDA, effective June 29, 2027, following HHS's announcement of termination of the COVID-19 EUA declaration. This is a material regulatory event that eliminates the company's primary authorized product and revenue source, but it is fundamentally a regulatory/legal matter rather than a financial restatement, going-concern issue, or other specific category. The company is in dialogue with the FDA regarding next steps, including potential Biologics License Application (BLA) submission, but the immediate event is the loss of regulatory authorization.","company_name":"Invivyd, Inc.","ticker":"IVVD","filing_date":"2026-07-06","form":"8-K","submitted_at":null,"items":[{"id":14083,"accession_number":"0001193125-26-295539","item_number":"8.01","item_title":"Other Events.","event_type":"legal_other","event_domain":"legal","is_material":true,"confidence":0.85,"reasoning":"Invivyd received a Notice of Termination of the Emergency Use Authorization (EUA) for PEMGARDA from the FDA, effective June 29, 2027, following HHS's announcement of termination of the COVID-19 EUA declaration. This is a material regulatory event that eliminates the company's primary authorized product and revenue source, but it is fundamentally a regulatory/legal matter rather than a financial restatement, going-concern issue, or other specific category. The company is in dialogue with the FDA regarding next steps, including potential Biologics License Application (BLA) submission, but the immediate event is the loss of regulatory authorization.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-06T11:12:37.766072+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":14083,"accession_number":"0001193125-26-295539","item_number":"8.01","item_title":"Other Events.","event_type":"legal_other","event_domain":"legal","is_material":true,"confidence":0.85,"reasoning":"Invivyd received a Notice of Termination of the Emergency Use Authorization (EUA) for PEMGARDA from the FDA, effective June 29, 2027, following HHS's announcement of termination of the COVID-19 EUA declaration. This is a material regulatory event that eliminates the company's primary authorized product and revenue source, but it is fundamentally a regulatory/legal matter rather than a financial restatement, going-concern issue, or other specific category. The company is in dialogue with the FDA regarding next steps, including potential Biologics License Application (BLA) submission, but the immediate event is the loss of regulatory authorization.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-07-06T11:12:37.766072+00:00","company_name":"Invivyd, Inc.","ticker":"IVVD","filing_date":"2026-07-06"}]}