{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-22-065556","form_type":"8-K","ticker":"HEPA","cik":"0001583771","company_name":"Hepion Pharmaceuticals, Inc.","filed_at":"2022-05-27T23:59:59+00:00","discovered_at":"2026-05-14T18:04:01.317575+00:00","generated_at":"2026-06-25T06:19:23.853820+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Hepion reports positive Phase 2a AMBITION NASH data; plans three Phase 2/2b trials starting Q3 2022","bullets":["Phase 2a AMBITION NASH trial met primary endpoints: safety, tolerability, PK; no serious adverse events.","Phase 2b ASCEND-NASH planned: 336 F2/F3 biopsy-proven NASH subjects, 12-month treatment, 3 doses vs placebo.","Phase 2 ALTITUDE-NASH to assess liver function in 60 F3 NASH subjects using HepQuant SHUNT test, 4-month duration.","Phase 2a HCC trial (Simon 2-stage) to enroll up to 42 advanced HCC subjects; primary endpoint disease control rate.","Screening and enrollment for all three studies expected to begin in Q3 2022."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-22-065556","json":"https://secwatch.observer/filing/0001104659-22-065556.json","markdown":"https://secwatch.observer/filing/0001104659-22-065556.md","text":"https://secwatch.observer/filing/0001104659-22-065556.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1583771/000110465922065556/0001104659-22-065556-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1583771/000110465922065556/tm2217120d1_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-25T06:19:23.853820+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"}