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.
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On April 17, 2023, Hepion Pharmaceuticals (NASDAQ:HEPA) announced that an abstract regarding its lead drug candidate, rencofilstat, will be presented by Chief Scientific Officer Daren Ure, PhD, at the American Association for Cancer Research Annual Meeting in Orlando, Florida, from April 15-19, 2023. The presentation, titled Rencofilstat Exerts a Dominant Role in Synergistic Anti-PD1-Combination Effects in a Fatty Liver Model of Hepatocellular Carcinoma, is scheduled for April 18, 2023, from 9:00 AM to 12:30 PM ET. Rencofilstat is currently in Phase 2 clinical trials for treating non-alcoholic steatohepatitis (NASH) and has received Fast Track and Orphan Drug designations from the FDA for its potential applications. The company utilizes its proprietary AI platform, AI-POWR™, for precision medicine in identifying responsive NASH patients.
Hepion Pharmaceuticals (NASDAQ:HEPA) has appointed four renowned experts to its Scientific Advisory Board (SAB) as of March 30, 2023. This move enhances the company’s expertise in liver disease research and drug development. The new members are Dr. Rohit Loomba, Dr. Vlad Ratziu, Dr. Yury V. Popov, and Dr. Nikolai Naoumov, each bringing extensive backgrounds in hepatology.
Their experience will support Hepion's clinical programs for rencofilstat, aimed at treating NASH and HCC. Rencofilstat is currently in Phase 2 trials, with FDA Fast Track and Orphan Drug designations. Hepion also employs an AI platform, AI-POWR™, to optimize patient outcomes in its drug development.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that CEO Robert Foster and SVP Patrick Mayo will present in the free webinar "How Artificial Intelligence is Changing Drug Discovery" on March 23, 2023, at 1:00 PM ET. They will showcase their AI-POWR™ platform, which enhances drug target selection and clinical study design for fibrotic diseases like NASH and HCC. The AI-POWR™ platform integrates extensive clinical data with publicly available multi-omic databases, identifying biomarkers for patient response to rencofilstat, Hepion's lead drug. This innovative approach aims to optimize ongoing clinical trials and improve patient outcomes in drug development.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that Chief Medical Officer Todd Hobbs will present an update on the NASH clinical program for rencofilstat at the Global NASH Congress on March 3, 2023. The presentation will cover the ASCEND-NASH and ALTITUDE-NASH trials, focusing on timelines and progress. The ASCEND-NASH trial, involving 90 sites across North America and Europe, aims for complete enrollment within 12 months. The ALTITUDE-NASH trial reached full enrollment in December 2022, with topline results expected in Q2 2023. The FDA has granted Fast Track and Orphan Drug designations for rencofilstat, highlighting its potential for treating NASH and HCC.
Hepion Pharmaceuticals has announced the granting of European Patent No. EP 3886813 for its lead drug candidate, rencofilstat, covering 38 European countries. This patent extends the exclusivity period to potentially 2048, providing a crucial competitive advantage. This extension builds on Hepion’s existing patent portfolio, originally set to expire in 2036. Rencofilstat, which inhibits cyclophilins and targets conditions like NASH and HCC, is in Phase 2 clinical trials and benefits from both FDA Fast Track and Orphan Drug designations.
CEO Robert Foster emphasized the importance of this patent for protecting rencofilstat's market potential amidst growing interest from researchers.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) announced that CEO Robert Foster will ring the Nasdaq Closing Bell on February 10, 2023. The event highlights the company’s focus on AI-driven therapeutic development for conditions like NASH and hepatocellular carcinoma. Rencofilstat, its lead drug candidate, has shown efficacy in reducing liver fibrosis and tumor burden and is currently in Phase 2 clinical development for NASH. The FDA has granted it both Fast Track and Orphan Drug designations. Hepion also introduced its AI-POWR™ platform, aimed at improving patient outcomes in clinical trials and exploring new therapeutic indications.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced encouraging results from preclinical studies on rencofilstat for multiple myeloma (MM). The drug showed complete cytotoxicity across 16 MM cell lines, including bortezomib-resistant types, when combined with bortezomib. Rencofilstat's effects correlated with reduced expression of targets cyclophilins A and D. The results align with previous studies advocating cyclophilin inhibition for treating resistant MM. CEO Robert Foster highlighted ongoing Phase 2 trials for NASH while exploring rencofilstat's broader therapeutic potential. The FDA has previously granted rencofilstat Fast Track and Orphan Drug designations.