Hepion Pharmaceuticals signs a letter of intent with New Day Diagnostics to in-license diagnostic tests for various diseases.
Quiver AI Summary
Hepion Pharmaceuticals has announced a binding letter of intent with New Day Diagnostics to in-license diagnostic tests for various conditions, including celiac disease, respiratory infections, H. pylori, and hepatocellular carcinoma (HCC). The tests, which have CE marks and are available for sale in Europe, represent a potential market exceeding $15 billion. Key diagnostics include a respiratory multiplex that detects multiple viruses, an H. pylori test for early infection detection, and a celiac disease screening test, each showing significant growth. This partnership is expected to leverage New Day’s existing distribution network in Europe to generate immediate revenue and facilitate the introduction of these tests into the U.S. market. Both companies expressed enthusiasm for the collaboration, highlighting its potential to improve early detection and health outcomes across various diseases.
Potential Positives
- Hepion Pharmaceuticals has entered a binding letter of intent with New Day Diagnostics to in-license diagnostic tests, expanding its portfolio and entering the lucrative diagnostics market.
- The addressable market for the licensed diagnostic tests exceeds $15 billion, presenting significant revenue potential for the company.
- The CE-marked diagnostic tests enable Hepion to generate near-term revenues in Europe through existing distributor networks.
- This partnership supports Hepion's strategic goal of enhancing early detection of diseases, potentially improving patient outcomes and company growth.
Potential Negatives
- The announcement of the in-licensing agreement comes after Hepion Pharmaceuticals decided to wind down its ASCEND-NASH clinical trial, indicating potential challenges in their core development program.
- The statement indicates ongoing reliance on third-party partnerships for revenue generation, highlighting a lack of independence in achieving commercial objectives.
- The press release includes numerous forward-looking statements that carry inherent risks, underscoring uncertainty regarding future performance and operational stability.
FAQ
What diagnostic tests is Hepion Pharmaceuticals in-licensing?
Hepion is in-licensing diagnostic tests for celiac disease, respiratory multiplex, H. pylori, and hepatocellular carcinoma (HCC).
What is the market potential for the new diagnostics?
The combined addressable market for the new diagnostics exceeds $15 billion, with specific segments showing significant growth.
How does this partnership benefit Hepion Pharmaceuticals?
This partnership allows Hepion to leverage New Day Diagnostics' distributor network for potential near-term revenue generation in Europe.
What is the expected growth rate for these diagnostics?
Market segments show varying growth rates, with the respiratory multiplex projected to grow at 6.6% annually through 2029.
What is Hepion Pharmaceuticals’ primary product?
Hepion's primary asset is Rencofilstat, a potent inhibitor targeting liver fibrosis and hepatocellular carcinoma tumor burden.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
MORRISTOWN, N.J., May 07, 2025 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company that had been developing a treatment for non-alcoholic steatohepatitis (“NASH”), hepatocellular carcinoma (“HCC”), and other chronic liver diseases, today announced that it has entered into a binding letter of intent (“LOI”) with New Day Diagnostics LLC to in-license 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 and are eligible to be sold in Europe at the present time.
The diagnostic tests covered under the LOI represent a combined addressable market exceeding $15 billion. The Respiratory Panel RT-PCR Multiplex CE-IVD addresses a $5.6 billion market, growing at 6.6% annually through 2029, by enabling efficient, simultaneous detection of COVID-19, Influenza A/B, and RSV from a single sample. The H. pylori CE-IVD targets the $700 million market for early, non-invasive detection of infections that can lead to gastric ulcers and cancer, with 6.0% projected growth through 2032. CeliaCare CE-IVD supports rapid screening for celiac disease—an underdiagnosed autoimmune condition—in a $457 million market growing at 10.4% annually through 2034. The mSEPT9 assay, when used in early detection of hepatocellular carcinoma (HCC) in high-risk patients, serves an $8.7 billion market projected to grow 6.7% annually through 2030. Collectively, these diagnostics offer clinical utility across multiple conditions while opening access to meaningful commercial opportunities in global markets.
John Brancaccio, Executive Chairman and Interim Chief Executive Officer of Hepion expressed his enthusiasm about this licensing opportunity: “The CE marked tests provide Hepion with the ability to generate near term revenues in European Union countries by leveraging the existing distributor network relationships that New Day Diagnostics has established. We are excited by this opportunity and look forward to working with New Day to maximize value.”
“This alliance represents a strategic step forward in our mission to bring accessible, high-impact diagnostics to patients around the world,” said Eric Mayer, CEO of New Day Diagnostics. “We’re excited to partner with Hepion to expand the reach of these CE-marked tests, bring them to the United States, and unlock new opportunities to improve early detection and outcomes across multiple disease areas.”
About Hepion Pharmaceuticals
Hepion’s primary asset, Rencofilstat, is a potent inhibitor of cyclophilins, which are involved in many disease processes. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental disease models.
In April 2024, Hepion announced that it was winding down its ASCEND-NASH clinical trial. This trial was designed as a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of Rencofilstat dosed for 12 months, with a target enrollment of 336 subjects. Enrollment was paused in April 2023, with 151 subjects randomized. To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy.
Hepion has been considering a number of assets to in-license and develop and Hepion’s Board of Directors believes that the opportunity offered by New Day Diagnostics presents a great opportunity to benefit Hepion’s stockholders.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Hepion Pharmaceuticals
[email protected]