Hepion Pharmaceuticals reports developments around its transition into precision diagnostics, with a focus on blood-based tests for hepatocellular carcinoma and other disease areas. Company updates include the ctRNA biomarker assay licensed for early diagnosis and surveillance of HCC, the mSEPT9 PCR-based assay for liver cancer detection, and diagnostic test categories covering celiac disease, respiratory multiplex testing, H. pylori, and HCC.
Hepion news also covers public-company status changes and capital actions, including OTCQB trading, reverse stock split activity, Nasdaq delisting developments, leadership changes, stockholder voting matters, and the completed sale of rencofilstat-related patent assets, knowhow, clinical trial data, and drug product.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) has appointed Anand Reddi and Kaouthar Lbiati to its Board of Directors. Reddi brings extensive experience in corporate strategy and drug development, while Lbiati has a strong background in global health policy and oncology. These appointments come as Hepion prepares to advance its lead drug candidate, rencofilstat, into three Phase 2 clinical trials, targeting NASH and hepatocellular carcinoma. Hepion has previously received FDA Fast Track and Orphan Drug designations for rencofilstat, highlighting its potential in treating these chronic diseases.
Hepion Pharmaceuticals (NASDAQ:HEPA) has adjourned its 2022 annual meeting to July 22, 2022, mainly concerning Proposal 4 (Authorized Share Increase). Votes representing about 60% of outstanding shares constituted a quorum. While elections for directors and the appointment of independent auditors passed, Proposals 3 (2022 Omnibus Equity Incentive Plan), 4 (Authorized Share Increase), and 5 (Say-On-Pay) did not receive sufficient support. The Board urges stockholders to vote for Proposal 4, emphasizing the necessity for additional shares for corporate flexibility, including future financings and acquisitions.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced FDA's Orphan Drug Designation for its drug rencofilstat, aimed at treating hepatocellular carcinoma (HCC). This designation highlights its potential to address significant unmet medical needs in an aggressive cancer type, which accounts for 85-90% of liver cancer cases. Hepion plans to initiate a Phase 2a study of rencofilstat in HCC in Q3 2022, alongside ongoing Phase 2 studies for non-alcoholic steatohepatitis (NASH). The Orphan Drug Designation offers various incentives, including potential seven-year market exclusivity and tax credits for clinical trials.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) announced that five abstracts were accepted for poster presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022, held from June 22 to 26, 2022, in London. These presentations focus on rencofilstat, a cyclophilin inhibitor in clinical development for non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). Key topics include its anti-tumor activities and anti-fibrotic effects demonstrated in clinical trials.
Hepion Pharmaceuticals (NASDAQ:HEPA) appointed Dr. Launa J. Aspeslet as Chief Operating Officer to bolster the clinical program for its lead candidate, rencofilstat. Dr. Aspeslet brings over 25 years of experience from her previous role as CEO of Translational Research in Oncology and significant contributions at Isotechnika Pharma. She joins Hepion after the company reported positive Phase 2a results and is preparing for three additional Phase 2 studies targeting non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). This leadership change aims to enhance strategic development.
Hepion Pharmaceuticals (NASDAQ:HEPA) encourages stockholders to vote 'FOR' all proposals ahead of the June 24, 2022, Annual Meeting. CEO Dr. Robert Foster highlighted the biotech sector's decline, necessitating shareholder support to advance their lead drug, rencofilstat, for NASH and HCC. Hepion prepares for three Phase 2 clinical trials of rencofilstat, expecting patient enrollment to start in Q3 2022. Approval of the 2022 Omnibus Equity Incentive Plan is critical to attract talent and resolve a current share issue, while a change in authorized shares is vital for future financing.
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Hepion Pharmaceuticals (NASDAQ:HEPA) announced the presentation of positive data from its Phase 2a ‘AMBITION’ NASH clinical trial at the 5th Global NASH Congress. Chief Medical Officer Todd Hobbs discussed upcoming trials for rencofilstat, focusing on three new studies: ASCEND-NASH, ALTITUDE-NASH, and HEPA-CRV431-209, all set to begin enrollment in Q3 2022. The company sees significant potential for rencofilstat in treating NASH and HCC, with FDA Fast Track designation already granted. The proprietary AI platform, AI-POWR™, will assist in identifying effective treatments for patients.
Hepion Pharmaceuticals (NASDAQ:HEPA) has launched a Phase 2b clinical trial to evaluate the efficacy of rencofilstat in treating non-alcoholic steatohepatitis (NASH) using the innovative HepQuant SHUNT test. This trial aims to assess liver function in 60 presumed NASH F3 subjects over four months. The SHUNT test promises to provide sensitive measurements that could replace invasive liver biopsies. Concurrently, Hepion will conduct a larger 12-month biopsy trial, enhancing its understanding of rencofilstat's impact on liver health. The FDA previously granted Fast Track designation to rencofilstat for NASH treatment.
Hepion Pharmaceuticals (NASDAQ: HEPA) announced that Dr. Todd Hobbs, its CMO, will present at the Q1 Investor Summit Conference on March 9, 2022, at 1:15 p.m. ET. The presentation will be accessible live and archived on their website. Hepion's lead candidate, rencofilstat, is a potent cyclophilin inhibitor currently under clinical development for non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). The FDA granted Fast Track designation for rencofilstat for NASH in November 2021, with an IND application for HCC accepted in December 2021.