{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-234385","form_type":"8-K","ticker":"MDGL","cik":"0001157601","company_name":"MADRIGAL PHARMACEUTICALS, INC.","filed_at":"2023-09-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.248023+00:00","generated_at":"2026-06-10T18:50:50.455327+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA accepts Madrigal's NDA for resmetirom for NASH with fibrosis, grants Priority Review","bullets":["PDUFA target action date set for March 14, 2024; FDA not currently planning an advisory committee meeting.","Priority Review shortens review to 6 months vs standard 10 months for a serious condition.","NDA supported by positive Phase 3 MAESTRO-NASH biopsy endpoints and large safety database from 18 studies.","Resmetirom is a once-daily oral THR-β agonist targeting key underlying causes of NASH in the liver."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-234385","json":"https://secwatch.observer/filing/0001193125-23-234385.json","markdown":"https://secwatch.observer/filing/0001193125-23-234385.md","text":"https://secwatch.observer/filing/0001193125-23-234385.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1157601/000119312523234385/0001193125-23-234385-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1157601/000119312523234385/d475156d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T18:50:50.455327+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"}