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 announced that the USAN Council has adopted the name rencofilstat for its lead drug candidate, CRV431, aimed at treating non-alcoholic steatohepatitis (NASH) and liver diseases. This name will be used in future publications and presentations as the company advances clinical development. Rencofilstat is a potent cyclophilin inhibitor, showing promise in reducing liver fibrosis and tumor burden in NASH models. The FDA granted Fast Track designation for rencofilstat in November 2021 and accepted its IND application for hepatocellular carcinoma in December 2021.
Hepion Pharmaceuticals (NASDAQ:HEPA) is set to participate in the virtual H.C. Wainwright BioConnect Conference from January 10-13, 2022. The company will offer a pre-recorded presentation available on-demand for registered attendees and on its website starting January 10. Hepion's lead drug candidate, CRV431, is in clinical development for treating non-alcoholic steatohepatitis (NASH), aiming to mitigate liver disease impacts. The company leverages its AI platform, AI-POWR™, to enhance patient selection and potentially expedite drug development timelines.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), announced that its Chief Medical Officer, Dr. Todd Hobbs, will present data from the Phase 2 AMBITION study at the NASH-TAG 2022 Conference on January 8, 2022. The presentation, titled 'Investigating CRV431 in NASH Patients: Data from the Phase 2a AMBITION Study,' was selected as one of the nine 'distinguished' abstracts for oral presentation. The company's lead drug candidate, CRV431, targets non-alcoholic steatohepatitis (NASH) and shows potential in reducing liver fibrosis and tumor burden in experimental models.
Hepion Pharmaceuticals has received FDA clearance for its investigational new drug (IND) application for CRV431, aimed at treating hepatocellular carcinoma (HCC). This IND allows CRV431 to advance directly into Phase 2 trials, complementing its existing development for non-alcoholic steatohepatitis (NASH). The drug, which is orally administered, has shown positive results in earlier trials and is designed to target liver disease effectively. Its potential benefits include enhanced patient experience and reduced side effects compared to traditional cancer therapies.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that the FDA granted Fast Track designation for its lead drug candidate, CRV431, in treating non-alcoholic steatohepatitis (NASH). This designation enables expedited approval reviews and facilitates early communication with the FDA. CRV431 has shown efficacy in early clinical trials and is set to enter a larger Phase 2b study called ASCEND-NASH. Given that approximately 5% of U.S. adults have NASH and no FDA-approved treatments exist, this designation is significant for advancing CRV431 to market.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced promising nonclinical research results for its lead drug CRV431, which significantly reduced liver tumor growth in a mouse model. The study demonstrated that CRV431 decreased tumor size by 76%, rivaling an anti-PD1 antibody, while a combination treatment further improved outcomes by 83%. Additionally, CRV431 positively altered immune cell populations in tumors, suggesting enhanced anti-cancer activity. These findings support CRV431’s potential for treating hepatocellular carcinoma and non-alcoholic steatohepatitis, addressing urgent medical needs.
Hepion Pharmaceuticals (HEPA) announced that results from its Phase 2a AMBITION NASH trial will be available as an e-poster at the virtual Liver Meeting® 2021 from November 12-15, 2021. The trial, involving 43 patients, focused on CRV431 administration and successfully met all primary endpoints, demonstrating safety and pharmacokinetics. The trial's findings suggest the efficacy of CRV431 for treating NASH. Additionally, Hepion plans to utilize its AI-POWR™ platform to optimize patient response and explore further indications for CRV431.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that a study on its lead drug candidate, CRV431, will be presented as an e-poster at the Liver Meeting® 2021 from November 12-15. The research, led by Dr. Philippe Gallay, demonstrates that cyclophilin D knockout mice showed significantly lower tumor burden scores, suggesting that cyclophilin inhibition could be an effective treatment for hepatocellular carcinoma (HCC) linked to non-alcoholic steatohepatitis (NASH). CRV431, an AI-driven therapeutic, aims to reduce liver disease progression, showing potential in treating NASH.
Hepion Pharmaceuticals (NASDAQ:HEPA), a clinical-stage biopharmaceutical company specializing in AI-driven drug development, announced that its CMO, Dr. Todd Hobbs, will present at the H.C. Wainwright 5th Annual NASH Investor Conference on October 12, 2021, at 4:00 p.m. ET. This virtual presentation will be accessible live and archived on the company's website.
The lead drug candidate, CRV431, is in clinical development for the treatment of NASH and aims to improve outcomes in liver disease. Hepion's proprietary platform, AI-POWR™, is designed to identify optimal NASH patient responses.
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.
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