{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-068170","form_type":"8-K","ticker":"MDGL","cik":"0001157601","company_name":"MADRIGAL PHARMACEUTICALS, INC.","filed_at":"2024-03-15T23:59:59+00:00","discovered_at":"2026-05-14T18:03:23.521467+00:00","generated_at":"2026-06-04T16:39:01.413889+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":1.0,"calibrated_materiality_score":1.0,"confidence":"high","headline":"Madrigal receives FDA accelerated approval for Rezdiffra, first NASH therapy","bullets":["FDA grants accelerated approval for Rezdiffra in NASH with F2-F3 fibrosis; first approved therapy for NASH.","Approval based on Phase 3 MAESTRO-NASH: improved fibrosis and NASH resolution at 52 weeks vs placebo.","Prescribing info does not require liver biopsy; weight-based dosing (80mg <100kg, 100mg >=100kg).","Rezdiffra expected available in US in April via specialty pharmacy; patient support programs.","Most common adverse reactions: diarrhea, nausea, pruritus, abdominal pain. Continued approval contingent on confirmatory outcomes data."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-068170","json":"https://secwatch.observer/filing/0001193125-24-068170.json","markdown":"https://secwatch.observer/filing/0001193125-24-068170.md","text":"https://secwatch.observer/filing/0001193125-24-068170.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1157601/000119312524068170/0001193125-24-068170-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1157601/000119312524068170/d788116d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T16:39:01.413889+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"}