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 received FDA clearance for its CRV431 investigational new drug application aimed at treating COVID-19. This follows promising preclinical results indicating reduced SARS-CoV-1 infectious virus production and lung inflammation. CRV431, a cyclophilin inhibitor, may address both viral infection and acute respiratory distress syndrome (ARDS). The company aims to initiate a Phase 2 study and seek partnerships for further development. Hepion remains focused on its primary indication, NASH, while exploring CRV431's broad therapeutic potential.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the successful completion of patient dosing in the 75 mg cohort of its Phase 2a AMBITION clinical trial for non-alcoholic steatohepatitis (NASH) and began dosing the first patient in the 225 mg cohort. The trial, involving 18 patients per dosing group, will assess safety, tolerability, and pharmacokinetics over 28 days. With a focus on identifying biomarkers for NASH, Hepion is utilizing its AI-POWR platform to enhance trial insights. The company anticipates valuable data to inform the upcoming Phase 2b trial in 2021.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced promising findings regarding CRV431, its lead drug candidate for treating non-alcoholic steatohepatitis (NASH). A study revealed that CRV431 reduced the formation of procoagulant platelets by up to 49%, potentially lowering the risk of ischemic strokes in patients with liver disease. While no significant effect on platelet aggregation was noted, these findings support CRV431's role in addressing the cardiovascular risks associated with NASH. The therapeutic shows safety and efficacy in previous clinical trials, indicating a multi-faceted approach to treating liver disease.
Hepion Pharmaceuticals (NASDAQ:HEPA) has completed its underwritten public offering of common stock, raising approximately $34.5 million in gross proceeds, with net proceeds around $31.7 million after expenses. The funds will primarily support research and development, along with general corporate purposes. The offering followed a registration statement declared effective on November 24, 2020. Hepion's lead candidate, CRV431, is under Phase 2 studies for treating non-alcoholic steatohepatitis (NASH).
Hepion Pharmaceuticals (NASDAQ:HEPA) has announced a public offering of 20 million shares of common stock priced at $1.50 per share, aiming to raise approximately $30 million before expenses. The offering includes a 45-day option for underwriters to purchase an additional 3 million shares. Proceeds will fund research and development, working capital, and corporate purposes. The offering is set to close on November 30, 2020, subject to customary conditions. This is part of the company's focus on therapeutic drugs for liver diseases, particularly NASH.
The independent Data Safety Monitoring Board (DSMB) has approved the continuation of Hepion Pharmaceuticals' Phase 2a AMBITION clinical trial for CRV431 in NASH patients. This approval follows the successful review of the 75 mg dose cohort, which showed no safety concerns and clinically significant reductions in liver enzymes ALT and AST. The trial will now advance to a 225 mg dose cohort. Approximately 17 million people in the U.S. suffer from NASH, leading to a significant unmet medical need.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced its participation in the Alliance Global Partners' Virtual Healthcare Symposium on November 19, 2020. This event will feature a series of one-on-one meetings with management. The company is focused on developing therapies for liver diseases, particularly non-alcoholic steatohepatitis (NASH). Their lead candidate, CRV431, has shown promise in reducing liver fibrosis and tumor burden in preclinical studies, with potential antiviral effects against HBV, HCV, and HDV.
Hepion Pharmaceuticals (NASDAQ:HEPA) will present virtual findings at The Liver Meeting Digital Experience 2020, hosted by the American Association for the Study of Liver Diseases, from November 13-16, 2020. The presentation will focus on the lead drug candidate CRV431, which demonstrated superior antifibrotic efficacy against liver fibrosis compared to other NASH drug candidates in an expanded study by FibroFind. Dr. Daren Ure, Chief Scientific Officer, highlighted CRV431’s unique mechanism targeting fibrotic scar formation. The session will occur on November 13, covering various aspects of NASH treatment.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the enrollment of the last patient in the 75 mg CRV431 cohort of its Phase 2a 'AMBITION' clinical trial, focused on non-alcoholic steatohepatitis (NASH). This milestone is crucial for assessing CRV431's safety, tolerability, and early efficacy indicators. The trial will involve 18 F2 and F3 NASH patients over 28 days. Data collected will utilize Hepion's AI-POWR platform for further analysis. Anticipated results from this cohort are expected by the end of 2020, highlighting Hepion's commitment to addressing the significant healthcare burden posed by NASH.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced its participation in two virtual conferences focusing on therapeutic approaches for COVID-19 and liver diseases. On October 28, 2020, Dr. Robert Foster will present CRV431, a drug candidate with demonstrated anti-viral activity against SARS-CoV-2, during the Roth Capital Healthcare event. The following day, Hepion will discuss CRV431’s potential for treating non-alcoholic steatohepatitis (NASH) at the B. Riley Securities event. Hepion aims to highlight CRV431's broad therapeutic potential, including anti-fibrotic and anti-inflammatory effects.