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 reports developments around its transition into precision diagnostics, with a focus on blood-based tests for hepatocellular carcinoma and other disease areas. Company updates include the ctRNA biomarker assay licensed for early diagnosis and surveillance of HCC, the mSEPT9 PCR-based assay for liver cancer detection, and diagnostic test categories covering celiac disease, respiratory multiplex testing, H. pylori, and HCC.
Hepion news also covers public-company status changes and capital actions, including OTCQB trading, reverse stock split activity, Nasdaq delisting developments, leadership changes, stockholder voting matters, and the completed sale of rencofilstat-related patent assets, knowhow, clinical trial data, and drug product.
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.