Hepion Pharmaceuticals, Inc.

Hepion Pharmaceuticals, Inc. is a medical diagnostic company headquartered in Morristown, New Jersey. The company previously focused on developing drug therapy for chronic liver diseases, with its lead molecule being rencofilstat (formerly CRV431), a cyclophilin inhibitor. Rencofilstat is a compound that binds and inhibits cyclophilins, a class of isomerase enzymes that regulate protein folding. Cyclophilins A, B, and D are the best-characterized isoforms in humans, and their inhibition has shown therapeutic effects in various experimental models, including 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. All clinical trial activities were completed, and the trial was closed in August 2024. On May 9, 2025, Hepion Pharmaceuticals entered into a License Agreement with New Day Diagnostics LLC to in-license certain diagnostic tests. These tests cover 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, making them eligible for sale in the European Union and certain other markets that accept the CE mark, excluding the United States at present. Under the License 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.