{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-255742","form_type":"8-K","ticker":"CPRX","cik":"0001369568","company_name":"CATALYST PHARMACEUTICALS, INC.","filed_at":"2023-10-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.776175+00:00","generated_at":"2026-06-09T23:56:05.570189+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":"FDA accepts Catalyst's sNDA to increase FIRDAPSE max dose to 100 mg; PDUFA June 4, 2024","bullets":["FDA accepted supplemental NDA to increase FIRDAPSE maximum daily dose from 80 mg to 100 mg for Lambert-Eaton myasthenic syndrome.","Prescription Drug User Fee Act action date set for June 4, 2024.","FIRDAPSE is currently approved for adults and children ages 6-17 with LEMS.","Chairman and CEO Patrick J. McEnany highlighted the milestone for addressing patient needs."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-255742","json":"https://secwatch.observer/filing/0001193125-23-255742.json","markdown":"https://secwatch.observer/filing/0001193125-23-255742.md","text":"https://secwatch.observer/filing/0001193125-23-255742.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1369568/000119312523255742/0001193125-23-255742-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1369568/000119312523255742/d896301d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-09T23:56:05.570189+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"}