{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-076358","form_type":"8-K","ticker":"CPRX","cik":"0001369568","company_name":"CATALYST PHARMACEUTICALS, INC.","filed_at":"2025-04-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:48.082370+00:00","generated_at":"2026-05-23T18:07:42.103557+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Catalyst Pharmaceuticals: Health Canada accepts AGAMREE NDS with Priority Review for DMD","bullets":["Health Canada accepted New Drug Submission for AGAMREE (corticosteroid) for Duchenne muscular dystrophy.","Submission granted Priority Review; potential marketing authorization before end of 2025.","If approved, AGAMREE would be first and only DMD treatment indicated in Canada.","AGAMREE already FDA-approved (Oct 2023) and commercially available in the U.S. since March 2024.","Sub-licensee Kye Pharmaceuticals markets FIRDAPSE in Canada for LEMS."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-076358","json":"https://secwatch.observer/filing/0001193125-25-076358.json","markdown":"https://secwatch.observer/filing/0001193125-25-076358.md","text":"https://secwatch.observer/filing/0001193125-25-076358.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1369568/000119312525076358/0001193125-25-076358-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1369568/000119312525076358/d941124d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-23T18:07:42.103557+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"}