Hepion Pharmaceuticals Stock Soars 19.14% on New Diagnostic Partnership

On May 7, 2025, Hepion Pharmaceuticals' stock surged by 19.14% in pre-market trading, marking a significant rise in investor interest and confidence in the company's recent strategic moves.

Hepion Pharmaceuticals has recently executed a binding letter of intent with New Day Diagnostics LLC to in-license diagnostic tests for multiple conditions. This strategic partnership aims to expand Hepion's diagnostic capabilities, covering a combined addressable market exceeding $15 billion. The diagnostic tests include those for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori), and hepatocellular carcinoma (HCC). These tests are already CE-marked and eligible for sale in Europe, providing Hepion with immediate revenue opportunities.

The respiratory multiplex test addresses a $5.6 billion market, growing at 6.6% annually through 2029. The H. pylori test targets a $700 million market with 6.0% projected growth through 2032. The celiac disease test supports a $457 million market growing at 10.4% annually through 2034. The mSEPT9 assay for early detection of hepatocellular carcinoma serves an $8.7 billion market projected to grow 6.7% annually through 2030. These diagnostics offer clinical utility across multiple conditions and open access to meaningful commercial opportunities in global markets.

John Brancaccio, Executive Chairman and Interim Chief Executive Officer of Hepion, expressed enthusiasm about this licensing opportunity, highlighting the potential for near-term revenues in the European Union by leveraging New Day Diagnostics' established distributor network relationships. Eric Mayer, CEO of New Day Diagnostics, also emphasized the strategic importance of this alliance in bringing accessible, high-impact diagnostics to patients worldwide.

Hepion's primary asset, Rencofilstat, is a potent inhibitor of cyclophilins involved in many disease processes. The company had been developing Rencofilstat as a treatment for non-alcoholic steatohepatitis (NASH), hepatocellular carcinoma (HCC), and other chronic liver diseases. However, in April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial, which was designed to evaluate the safety and efficacy of Rencofilstat dosed for 12 months. The trial was paused in April 2023, with 151 subjects randomized and approximately 80 subjects completing their Day 365 visits.

Despite the challenges faced with the ASCEND-NASH trial, Hepion's Board of Directors believes that the opportunity offered by New Day Diagnostics presents a significant benefit to Hepion's stockholders. The company is considering a number of assets to in-license and develop, and this partnership with New Day Diagnostics is seen as a strategic step forward in Hepion's mission to bring accessible, high-impact diagnostics to patients around the world.