{"schema_version":"secwatch.filing_event.v1","accession":"0001689548-26-000082","form_type":"8-K","ticker":"PRAX","cik":"0001689548","company_name":"Praxis Precision Medicines, Inc.","filed_at":"2026-08-06T12:31:27+00:00","discovered_at":"2026-08-06T12:35:01.361498+00:00","generated_at":"2026-08-06T12:35:16.714653+00:00","sec_items":["2.02","7.01","9.01"],"event_type":"earnings","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Praxis Q2 net loss $83.7M; FDA mid-cycle positive for ulixacaltamide and relutrigine; no AdCom","bullets":["FDA mid-cycle meetings for ulixacaltamide (ET) and relutrigine (DEEs) found no major safety/efficacy concerns; no advisory committee planned; PDUFA dates Jan 29, 2027 and Dec 27, 2026.","BIMO inspections for both NDAs completed with no Form 483 observations.","Third Breakthrough Therapy Designation granted for elsunersen in SCN2A DEE (gain-of-function).","Q2 2026 net loss $83.7M; cash $1.4B, runway into 2028.","Vormatrigine POWER1 missed primary endpoint but met secondary; plans to restart POWER2 and start POWER3 in Q4 2026."],"urls":{"canonical":"https://secwatch.observer/filing/0001689548-26-000082","json":"https://secwatch.observer/filing/0001689548-26-000082.json","markdown":"https://secwatch.observer/filing/0001689548-26-000082.md","text":"https://secwatch.observer/filing/0001689548-26-000082.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/0001689548-26-000082-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1689548/000168954826000082/prax-20260806.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-06T12:35:16.714653+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"}