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, Inc. (NASDAQ:HEPA) announced that CEO Robert Foster will present at the ThinkEquity Conference in New York City on October 26, 2022, at 1:30 p.m. ET. The presentation will be live-streamed and archived on their website. Hepion's lead drug candidate, rencofilstat, targets non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). It has received Fast Track and Orphan Drug designations from the FDA, demonstrating its potential in treating liver diseases. The company utilizes its proprietary AI-POWR™ platform to enhance drug response insights.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its Chief Medical Officer, Todd Hobbs, MD, will participate in the "Novel Targets in Oncology: Risk vs. Reward" panel at the Cantor Oncology, Hematology & HemeOnc Conference on September 28, 2022. Dr. Hobbs will discuss the Phase 2 clinical trial of rencofilstat, targeted at treating hepatocellular carcinoma (HCC). Rencofilstat has shown promise in reducing liver fibrosis and HCC tumor burden, and has received Fast Track and Orphan Drug designations from the FDA for its development in treating NASH and HCC, respectively.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced its collaboration with London's Institute of Hepatology to present new findings on rencofilstat at the ISBRA and ESBRA joint meeting in Cracow, Poland, from September 17-20, 2022. The study highlights rencofilstat's effectiveness against Alcohol-associated Liver Disease (ALD) by targeting cyclophilins, which are implicated in liver damage. Results showed significant reductions in fibrosis markers and improved cytokine profiles in liver tissue models. CEO Dr. Robert Foster emphasized rencofilstat's potential in treating ALD-induced fibrosis.
Hepion Pharmaceuticals has initiated a Phase 2 clinical trial for rencofilstat, targeting non-alcoholic steatohepatitis (NASH). The ALTITUDE-NASH study will assess 60 adult subjects over four months, with doses of 75, 150, or 225 mg. The trial's goal is to evaluate hepatic function using HepQuant's SHUNT test and other NASH biomarkers. This collaboration with HepQuant and Summit Clinical Research highlights the pressing need for effective NASH treatments, as the disease poses significant health risks without FDA-approved therapies.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) will participate in the H.C. Wainwright 24th Annual Global Investment Conference, with a pre-recorded presentation available on demand for attendees from September 12, 2022. The company is focused on developing rencofilstat, an AI-driven therapeutic for chronic liver diseases, including non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). Rencofilstat has received FDA Fast Track and Orphan Drug designations, demonstrating its potential in addressing liver disease and improving patient outcomes.
Hepion Pharmaceuticals has announced the screening of the first subject in its ASCEND-NASH clinical trial, aimed at studying rencofilstat for treating non-alcoholic steatohepatitis (NASH). The Phase 2b trial will involve 336 subjects over one year, focusing on F2/F3 fibrosis levels, with a target for 60% F3 subjects. Rencofilstat aims to improve fibrosis and steatosis scores. The trial will also employ AI-POWR™ technology to identify patients likely to respond positively. Hepion received FDA Fast Track designation for rencofilstat in November 2021, facilitating smoother transitions through clinical phases.
Hepion Pharmaceuticals (NASDAQ:HEPA) has announced the adjournment of its 2022 annual meeting to August 5, 2022, at 9:00 a.m. ET regarding Proposal 4 for an authorized share increase. The record date for voting remains April 26, 2022. Proxies representing about 60% of shares have been submitted, allowing for a quorum. The Board believes that approving this proposal will provide flexibility for future financings and other purposes. Shareholders are encouraged to vote by August 4, 2022, at 11:59 p.m. ET.
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.