{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-187698","form_type":"8-K","ticker":"MDGL","cik":"0001157601","company_name":"MADRIGAL PHARMACEUTICALS, INC.","filed_at":"2023-07-17T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.247616+00:00","generated_at":"2026-06-13T07:30:22.931726+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":"Madrigal completes NDA submission to FDA for resmetirom for NASH with liver fibrosis","bullets":["Completed rolling NDA submission to FDA for resmetirom for NASH with liver fibrosis; priority review requested.","Phase 3 MAESTRO-NASH met both primary liver biopsy endpoints: NASH resolution and fibrosis reduction.","Resmetirom granted Breakthrough Therapy designation by FDA in April 2023.","Two ongoing Phase 3 outcomes studies (MAESTRO-NASH-OUTCOMES, MAESTRO-NAFLD-OLE) to support full approval.","No approved therapy exists for NASH; resmetirom targets key underlying causes as THR-β agonist."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-187698","json":"https://secwatch.observer/filing/0001193125-23-187698.json","markdown":"https://secwatch.observer/filing/0001193125-23-187698.md","text":"https://secwatch.observer/filing/0001193125-23-187698.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1157601/000119312523187698/0001193125-23-187698-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1157601/000119312523187698/d508608d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-13T07:30:22.931726+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"}