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) announced results from a Drug-Drug Interaction study of its lead drug candidate, CRV431, which targets cyclophilins to treat non-alcoholic steatohepatitis (NASH). The study showed that CRV431's pharmacokinetics were significantly enhanced when administered with ketoconazole, increasing Cmax five-fold and AUC0-24 nearly four-fold. Importantly, CRV431's interaction with midazolam was minimal, indicating its compatibility with other medications. The findings confirm CRV431's safety profile and potential for treating NASH patients with multiple drug therapies.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced promising results from its Phase 2a AMBITION trial of CRV431, aimed at treating non-alcoholic steatohepatitis (NASH). The trial showed significant reductions in biomarkers Pro-C3 and alanine aminotransferase (ALT), suggesting anti-inflammatory and antifibrotic effects. Advanced AI-POWR™ models indicated accurate predictions of patient responses to treatment. The study's success sets a foundation for the upcoming Phase 2b ASCEND-NASH trial, which aims to further evaluate CRV431's efficacy in NASH patients.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced it will release additional data from its Phase 2a AMBITION NASH clinical trial on September 13, 2021. The trial has already achieved all primary endpoints, and a conference call is scheduled for the same day to discuss the topline results and new data. The company's lead drug candidate, CRV431, is positioned to address non-alcoholic steatohepatitis (NASH) and liver disease. Hepion's proprietary AI platform, AI-POWR™, aims to enhance patient selection and drive clinical development for CRV431 and potentially other indications.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the postponement of its 2021 Annual Meeting of Stockholders originally scheduled for July 23, 2021, due to a lack of quorum. The Board of Directors will determine a new date and record date for the meeting. Hepion's lead drug candidate, CRV431, is under development for non-alcoholic steatohepatitis (NASH) and has shown promise in reducing liver fibrosis and hepatocellular carcinoma in preclinical studies. The company also introduced AI-POWR™, an AI platform aimed at improving patient response identification for CRV431.
Hepion Pharmaceuticals announced positive topline results from its Phase 2a AMBITION trial of CRV431, targeting non-alcoholic steatohepatitis (NASH). All primary endpoints were met, with no serious adverse events reported, indicating good safety and tolerability. The trial showed significant reductions in serum alanine aminotransferase (ALT) levels, a key NASH biomarker, suggesting a strong dose-response effect. Hepion plans to initiate a Phase 2b trial later in 2021, utilizing insights from the AMBITION trial to enhance CRV431’s development for NASH treatment.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the adjournment of its 2021 Annual Meeting of Stockholders originally scheduled for June 25, 2021, due to a lack of quorum. The meeting will now take place on July 23, 2021, at 9:00 a.m. ET. The record date for eligible voters remains April 29, 2021. Stockholders are encouraged to vote via Internet, mail, or in-person at the rescheduled meeting. Hepion’s lead candidate, CRV431, is in clinical development for treating NASH and is supported by their AI platform, AI-POWR™, aimed at optimizing patient response.
Hepion Pharmaceuticals (NASDAQ:HEPA) will join the Russell Microcap® Index on June 28, enhancing its visibility to institutional investors. This membership is seen as a milestone in Hepion's efforts to increase shareholder value through the clinical development of its lead candidate, CRV431, aimed at treating NASH and liver diseases. The Russell indexes are widely regarded benchmarks for $10.6 trillion in assets. Inclusion in these indexes could attract new investors and facilitate growth opportunities for the company.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the completion of patient recruitment for its Phase 2a 'AMBITION' clinical trial focused on treating NASH. The trial enrolled patients in the 225 mg CRV431 cohort, overcoming delays due to COVID-19 and adverse weather conditions. Following 28 days of dosing, subjects will be monitored for an additional 14 days to assess safety, tolerability, pharmacokinetics, and early efficacy biomarker analyses of CRV431. The study aims to gather critical data using Hepion's AI-POWR™ platform to enhance precision medicine approaches for NASH treatment.
Hepion Pharmaceuticals (NASDAQ:HEPA) has announced a virtual presentation by Dr. Patrick Mayo, Senior VP of Clinical Pharmacology, at the 4th Global NASH Congress, focusing on the development of CRV431, its lead candidate for treating non-alcoholic steatohepatitis (NASH). Dr. Mayo discussed the impact of cyclophilins on disease processes and the application of AI-POWR™, Hepion's AI platform, in optimizing clinical trials. The company aims to streamline trial processes and enhance efficacy through predictive modeling and bioinformatics.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced positive results from an in vivo study of CRV431 targeting non-alcoholic steatohepatitis (NASH). The study showed a 47% reduction in fibrosis in a Diet-Induced Animal Model Of Non-alcoholic fatty liver Disease (DIAMOND). CRV431 demonstrated consistent antifibrotic effects across multiple studies, with ongoing Phase 2a clinical trials evaluating safety and pharmacokinetics in NASH patients. Hepion aims to leverage its AI-POWR™ platform for further biomarker identification and clinical efficacy evaluation.