Welcome to our dedicated page for Hepion Pharmaceuticals news (Ticker: HEPA), a resource for investors and traders seeking the latest updates and insights on Hepion Pharmaceuticals stock.
Hepion Pharmaceuticals, Inc. (HEPA) generates news that reflects its transition from liver-focused drug development to diagnostic testing and its evolving capital markets profile. Company announcements describe Hepion as a clinical stage biopharmaceutical firm that had been developing rencofilstat, a cyclophilin inhibitor for non-alcoholic steatohepatitis (NASH), hepatocellular carcinoma (HCC) and other chronic liver diseases, and that is now concentrating on diagnostic tests for celiac disease, respiratory multiplex (Covid/Influenza A/B and RSV), helicobacter pylori (H. pylori) and HCC.
News items for HEPA commonly cover strategic shifts and partnerships, such as Hepion’s license agreement with New Day Diagnostics LLC to in-license diagnostic tests in these areas. Releases also discuss the status of its ASCEND-NASH Phase 2b clinical trial, including the decision to wind down and close the trial, and the subsequent sale of rencofilstat-related patent assets, knowhow and clinical data in exchange for a nominal amount and a contingent value right for stockholders.
Investors following HEPA will also find capital markets and listing updates in the news feed. Hepion has reported a reverse stock split intended to address Nasdaq’s minimum bid price requirement, a public offering of common stock and warrants, and later a delisting notification from Nasdaq citing continued listing standard deficiencies and concerns that the company was a public shell. Subsequent news confirms the suspension of trading on Nasdaq and the transition of HEPA shares to quotation on the OTCQB Venture Market.
The HEPA news stream further includes corporate transaction and governance developments, including the proposed but ultimately terminated merger with Pharma Two B Ltd., the effectiveness and later cancellation of a special stockholder meeting related to that transaction, and leadership changes such as the appointment of an interim Chief Executive Officer and the resignation of a chief financial officer and director. For readers tracking the company’s evolution toward precision diagnostics and its efforts to manage capital and strategic alternatives, the HEPA news page offers an organized view of these disclosures.
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.
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.
Hepion Pharmaceuticals (NASDAQ:HEPA) appointed Dr. Eddie C. Cheung to lead Strategic Medical Affairs in Asia, advancing the development of rencofilstat for NASH and hepatocellular carcinoma (HCC). Dr. Cheung's extensive experience in gastroenterology and hepatology will facilitate partnerships and regulatory interactions in Asia. His role is crucial given that over 75% of global liver cancer cases occur in Asia, with China accounting for a significant portion. Hepion aims to leverage AI-POWR™ to enhance treatment strategies for NASH and expand its therapeutic reach.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that CEO Dr. Robert Foster will present at the BIO CEO & Investor Conference on February 15, 2022, at 11:15 AM ET in New York. The presentation will focus on the company's lead drug candidate, rencofilstat, which targets non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). This candidate has received FDA Fast Track designation and shows promise in reducing liver fibrosis and tumor burden. Hepion's proprietary AI platform, AI-POWR™, aims to optimize treatment strategies for NASH patients.
Hepion Pharmaceuticals announced promising results for its drug candidate rencofilstat (CRV431) in treating liver cancer in a recent study. Conducted alongside Newcastle University, the research revealed that combining rencofilstat with an anti-PD1 antibody significantly reduced tumor growth by 69% and increased survival time in mice by 26%. This combination therapy addresses the challenges posed by non-alcoholic fatty liver disease, which can hinder anti-PD1 treatment efficacy. Hepion has FDA approval to initiate a phase 2a study for rencofilstat in hepatocellular carcinoma.
Hepion Pharmaceuticals (NASDAQ:HEPA) sadly reports the passing of Thomas Adams, Ph.D., a Board member, on January 9, 2022. Dr. Adams, who joined the Board in September 2016, was a renowned figure in biotechnology. The Chairman, Gary S. Jacob, expressed condolences, emphasizing Adams' significant contributions and impact on the company. Hepion's lead drug candidate, rencofilstat, is advancing in clinical-phase development for NASH and has received Fast Track designation from the FDA. The company is leveraging its AI platform, AI-POWR™, to enhance patient response in treatment and explore additional indications for rencofilstat.
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