Hepion Pharmaceuticals, Inc.

Hepion Pharmaceuticals, Inc. is a medical diagnostic company headquartered in Morristown, New Jersey. The company was previously focused on developing drug therapy for chronic liver diseases, specifically its cyclophilin inhibitor, rencofilstat (formerly CRV431). Rencofilstat is a compound designed to bind and inhibit cyclophilin isomerase enzymes, which regulate protein folding. Cyclophilins A, B, and D are the best-characterized isoforms. Scientific literature indicates that inhibiting cyclophilins may have therapeutic effects, including in liver disease models. On April 19, 2024, the company announced the wind-down of its ASCEND-NASH clinical trial due to insufficient funding to complete the study as designed. Wind-down activities ensured patient safety and met minimum FDA requirements for closing a clinical trial, with all activities completed and the trial closed in August 2024. On May 9, 2025, Hepion Pharmaceuticals entered into a License Agreement with New Day Diagnostics LLC, in-licensing diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori), and hepatocellular carcinoma (HCC). The celiac, respiratory multiplex, and H. pylori tests have CE marks, allowing them to be sold in the European Union and certain eligible markets that accept the CE mark, excluding the United States currently. Under the agreement, Hepion Pharmaceuticals paid New Day $525,000 in cash and $270,629 in shares of its common stock, and agreed to pay up to $17.15 million upon achieving specific regulatory, sales, and reimbursement milestones.