{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-21-151970","form_type":"8-K","ticker":"HEPA","cik":"0001583771","company_name":"Hepion Pharmaceuticals, Inc.","filed_at":"2021-12-21T23:59:59+00:00","discovered_at":"2026-05-14T18:04:13.149891+00:00","generated_at":"2026-06-27T23:19:51.155467+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":"Hepion Pharma gets FDA IND clearance for CRV431 in liver cancer (HCC), enabling direct Phase 2 start","bullets":["FDA accepted IND for CRV431 for hepatocellular carcinoma; allows Phase 2 trial to begin without Phase 1.","CRV431 is a liver-targeting cyclophilin inhibitor; also being studied for NASH with Phase 2b ASCEND-NASH expected in 2022.","Positive Phase 2a AMBITION NASH data previously reported; CRV431 well-tolerated with all primary endpoints met.","Company highlights CRV431's oral dosing and potential anti-tumor mechanisms including immune modulation.","Expansion into HCC complements existing NASH pipeline with a single once-daily oral agent."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-21-151970","json":"https://secwatch.observer/filing/0001104659-21-151970.json","markdown":"https://secwatch.observer/filing/0001104659-21-151970.md","text":"https://secwatch.observer/filing/0001104659-21-151970.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583771/000110465921151970/0001104659-21-151970-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583771/000110465921151970/tm2135984d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-27T23:19:51.155467+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"}