Hepion Pharmaceuticals Executes Binding Letter of Intent with New Day Diagnostics to Commercialize Diagnostic Tests for Celiac Disease, Respiratory Multiplex, H. Pylori and HCC

Core Insights - Hepion Pharmaceuticals has entered into a binding letter of intent with New Day Diagnostics to in-license diagnostic tests for various diseases, including celiac disease and hepatocellular carcinoma [1][2][3] - The combined addressable market for these diagnostic tests exceeds $15 billion, with significant growth projections across multiple segments [2] Company Developments - The diagnostic tests include CE-marked products that are eligible for sale in Europe, allowing Hepion to generate near-term revenues through existing distributor networks [3] - Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which has shown efficacy in reducing liver fibrosis and tumor burden in experimental models [4] - The company previously announced the winding down of its ASCEND-NASH clinical trial, which was paused in April 2023 after randomizing 151 subjects [5][6] Market Opportunities - The Respiratory Panel RT-PCR Multiplex CE-IVD targets a $5.6 billion market, growing at 6.6% annually through 2029, while the H. pylori test addresses a $700 million market with a 6.0% growth rate projected through 2032 [2] - The celiac disease screening test operates in a $457 million market, expected to grow at 10.4% annually through 2034, and the mSEPT9 assay for HCC detection serves an $8.7 billion market with a 6.7% growth rate projected through 2030 [2]