{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-26-000066","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2026-06-22T20:43:01+00:00","discovered_at":"2026-06-22T20:44:00.286808+00:00","generated_at":"2026-06-22T20:44:12.688716+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA grants Breakthrough Therapy Designation for Praxis Precision Medicines' elsunersen for SCN2A-DEE","bullets":["FDA granted Breakthrough Therapy Designation for elsunersen (PRAX-222), an antisense oligonucleotide for seizures in SCN2A Developmental and Epileptic Encephalopathy.","BTD expedites development and regulatory review; supported by positive topline data from EMBRAVE Part A trial.","EMBRAVE Part A was a randomized, sham-controlled Phase 1/2 study in nine pediatric patients aged 2–12 years with early-seizure-onset SCN2A-DEE.","The designation covers Gain of Function variants in SCN2A."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-26-000066","json":"https://secwatch.observer/filing/0001689548-26-000066.json","markdown":"https://secwatch.observer/filing/0001689548-26-000066.md","text":"https://secwatch.observer/filing/0001689548-26-000066.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000066/0001689548-26-000066-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000066/prax-20260622.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-22T20:44:12.688716+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}