{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-265168","form_type":"8-K","ticker":"CPRX","cik":"0001369568","company_name":"CATALYST PHARMACEUTICALS, INC.","filed_at":"2023-10-27T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.776690+00:00","generated_at":"2026-06-09T06:51:22.874940+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Catalyst reports FDA approval of AGAMREE for DMD; expects Q1 2024 launch","bullets":["Santhera received FDA approval for AGAMREE (vamorolone) oral suspension 40 mg/mL for DMD in patients aged 2+.","Catalyst holds exclusive North American license; NDA transfer from Santhera to Catalyst is prompt.","Catalyst expects to commercially launch AGAMREE in Q1 2024 with a patient assistance program.","AGAMREE has orphan drug exclusivity (7 years) and patent protection potentially until 2040.","Approval based on Phase 2b VISION-DMD study and open-label extension data up to 48 months."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-265168","json":"https://secwatch.observer/filing/0001193125-23-265168.json","markdown":"https://secwatch.observer/filing/0001193125-23-265168.md","text":"https://secwatch.observer/filing/0001193125-23-265168.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1369568/000119312523265168/0001193125-23-265168-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1369568/000119312523265168/d577328d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T06:51:22.874940+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"}