{"filing":{"accession_number":"0001689548-26-000069","cik":"0001689548","ticker":"PRAX","company_name":"Praxis Precision Medicines, Inc.","form":"8-K","filing_date":"2026-06-29","report_date":null,"primary_document":"prax-20260629.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000069/prax-20260629.htm"},"events":[{"id":14700,"run_id":13094,"accession_number":"0001689548-26-000069","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The FDA extended the PDUFA review period for relutrigine's NDA by three months (from September 27 to December 27, 2026) following submission of additional sensitivity analyses. This is a material regulatory milestone affecting the timing of a potential product approval for a company in clinical-stage development, but it does not fit neatly into the specific event categories (not a restatement, impairment, covenant breach, or other defined event). The extension itself is not adverse—no safety or manufacturing concerns were cited—making it an operational/regulatory development rather than a crisis event.","company_name":"Praxis Precision Medicines, Inc.","ticker":"PRAX","filing_date":"2026-06-29","form":"8-K","submitted_at":null,"items":[{"id":12208,"accession_number":"0001689548-26-000069","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA extended the PDUFA review period for relutrigine's NDA by three months (from September 27 to December 27, 2026) following submission of additional sensitivity analyses. This is a material regulatory milestone affecting the timing of a potential product approval for a company in clinical-stage development, but it does not fit neatly into the specific event categories (not a restatement, impairment, covenant breach, or other defined event). The extension itself is not adverse—no safety or manufacturing concerns were cited—making it an operational/regulatory development rather than a crisis event.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-29T20:41:45.281427+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":12208,"accession_number":"0001689548-26-000069","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA extended the PDUFA review period for relutrigine's NDA by three months (from September 27 to December 27, 2026) following submission of additional sensitivity analyses. This is a material regulatory milestone affecting the timing of a potential product approval for a company in clinical-stage development, but it does not fit neatly into the specific event categories (not a restatement, impairment, covenant breach, or other defined event). The extension itself is not adverse—no safety or manufacturing concerns were cited—making it an operational/regulatory development rather than a crisis event.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-29T20:41:45.281427+00:00","company_name":"Praxis Precision Medicines, Inc.","ticker":"PRAX","filing_date":"2026-06-29"}]}