---
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"
generated_at: "2026-06-27T23:19:51.155467+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Hepion Pharma gets FDA IND clearance for CRV431 in liver cancer (HCC), enabling direct Phase 2 start

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-21-151970
- JSON: https://secwatch.observer/filing/0001104659-21-151970.json
- Plain text: https://secwatch.observer/filing/0001104659-21-151970.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.