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. (NASDAQ: HEPA) is a biopharmaceutical company headquartered in Edison, New Jersey. Founded in 2013, the company focuses on developing advanced drug therapies for chronic liver diseases. Hepion's core mission is to enhance treatment options for liver conditions such as non-alcoholic steatohepatitis (NASH), viral hepatitis, and hepatocellular carcinoma (HCC).
The company's flagship product is Rencofilstat, a pan-cyclophilin inhibitor designed to target multiple pathological pathways involved in liver disease progression. This pleiotropic drug therapy has shown promising results in preclinical and clinical trials, including recently completed Phase I trials. Rencofilstat is currently being studied for its potential to address complex liver pathologies, including fibrosis and cancerous conditions associated with NASH and hepatitis.
Another significant development from Hepion is Tenofovir Exalidex, a lipid acyclic nucleoside phosphonate intended to deliver high intracellular concentrations of tenofovir diphosphate, an active antiviral agent. This drug aims to offer more effective treatment options for Hepatitis B patients.
Hepion Pharmaceuticals has also made headlines with its adoption of artificial intelligence (AI)-driven drug development, focusing on precision medicine for chronic diseases. Recent research has revealed that Rencofilstat may exert anti-cancer activity through mechanisms such as altering DNA accessibility, silencing oncogenes, and activating tumor suppressor genes.
The company was formerly known as ContraVir Pharmaceuticals, Inc. before rebranding to Hepion Pharmaceuticals in July 2019 to better align with its focus on liver disease therapies. With a commitment to cutting-edge research and development, Hepion Pharmaceuticals continues to advance its clinical programs and partnerships, offering hope to patients suffering from debilitating liver diseases.
Hepion Pharmaceuticals has announced the granting of European Patent No. EP 3886813 for its lead drug candidate, rencofilstat, covering 38 European countries. This patent extends the exclusivity period to potentially 2048, providing a crucial competitive advantage. This extension builds on Hepion’s existing patent portfolio, originally set to expire in 2036. Rencofilstat, which inhibits cyclophilins and targets conditions like NASH and HCC, is in Phase 2 clinical trials and benefits from both FDA Fast Track and Orphan Drug designations.
CEO Robert Foster emphasized the importance of this patent for protecting rencofilstat's market potential amidst growing interest from researchers.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA) announced that CEO Robert Foster will ring the Nasdaq Closing Bell on February 10, 2023. The event highlights the company’s focus on AI-driven therapeutic development for conditions like NASH and hepatocellular carcinoma. Rencofilstat, its lead drug candidate, has shown efficacy in reducing liver fibrosis and tumor burden and is currently in Phase 2 clinical development for NASH. The FDA has granted it both Fast Track and Orphan Drug designations. Hepion also introduced its AI-POWR™ platform, aimed at improving patient outcomes in clinical trials and exploring new therapeutic indications.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced encouraging results from preclinical studies on rencofilstat for multiple myeloma (MM). The drug showed complete cytotoxicity across 16 MM cell lines, including bortezomib-resistant types, when combined with bortezomib. Rencofilstat's effects correlated with reduced expression of targets cyclophilins A and D. The results align with previous studies advocating cyclophilin inhibition for treating resistant MM. CEO Robert Foster highlighted ongoing Phase 2 trials for NASH while exploring rencofilstat's broader therapeutic potential. The FDA has previously granted rencofilstat Fast Track and Orphan Drug designations.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced significant findings from a preclinical study on its lead candidate, rencofilstat, presented by collaborator Dr. Carlos Perez-Stable at the Florida Cancer Symposium. The study explored the combination of rencofilstat with ixazomib, showing that together they induced proteotoxic stress, killing 70-90% of various prostate cancer cell lines without harming non-cancer cells. This suggests potential advancements in cancer treatment applications for rencofilstat, alongside its ongoing Phase 2 trials for non-alcoholic steatohepatitis (NASH).
Hepion Pharmaceuticals (NASDAQ:HEPA) announced the successful sale of approximately $2.9 million in net operating losses (NOLs) through New Jersey's NOL program. Additionally, the company secured $309,000 from the Alberta Innovation Employment Grant. This funding will support their R&D efforts, particularly in developing their oral drug candidate rencofilstat, aimed at treating non-alcoholic steatohepatitis (NASH) and hepatocellular carcinoma (HCC). With approximately $59.1 million in cash at the end of Q3-2022, Hepion aims to enhance its clinical development and innovation.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its lead drug candidate, rencofilstat, will be presented at the NASH-TAG 2023 Conference from January 5-7, 2023. The presentation, titled Rencofilstat Multiomics Data Indicate Clinically Important Mechanisms in NAFLD-NASH, highlights the drug's potential in treating fibrotic diseases like NASH and HCC. Rencofilstat has shown to reduce liver fibrosis and cancer tumor burden while receiving Fast Track and Orphan Drug designations from the FDA, indicating its promising therapeutic potential.
Hepion Pharmaceuticals (Nasdaq:HEPA) has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement of $1.00 per share. The deadline to meet this requirement is now May 30, 2023. If the stock price closes at or above $1.00 for ten consecutive business days, Nasdaq will confirm compliance. This follows Hepion's previous notification in June 2022 regarding non-compliance. Failure to meet the requirement may lead to delisting, although Hepion can appeal any potential delisting decision.
Hepion Pharmaceuticals has successfully enrolled 60 NASH stage 3 subjects in its Phase 2 ALTITUDE-NASH clinical trial within just 12 weeks, utilizing the innovative AGILE 3+ non-invasive test. This trial aims to assess the safety and efficacy of rencofilstat over four months, with subjects receiving varying doses of the drug. The results are anticipated by Q2 2023, which could influence future trials and provide insight into liver function improvements. Hepion's approach seeks to reduce dependency on liver biopsies, potentially enhancing enrollment rates and study efficiency.
On November 7, 2022, Hepion Pharmaceuticals (NASDAQ:HEPA) announced that its Chief Scientific Officer, Daren Ure, PhD, will present data at the 6th Annual Antifibrotic Drug Development Summit in Boston from November 9-11, 2022. The presentation will focus on the poly-indication potential of rencofilstat, a leading candidate aimed at treating fibrotic diseases such as NASH and HCC. Rencofilstat has shown efficacy in reducing fibrosis across various organs, bolstered by data from 15 preclinical studies, highlighting its promise as a versatile therapeutic option.
Hepion Pharmaceuticals (NASDAQ:HEPA) announced a securities purchase agreement to sell 1,900,000 shares of Series F convertible redeemable preferred stock and 100,000 shares of Series G convertible redeemable preferred stock at $9.50 per share, aiming for $20 million in gross proceeds. Both preferred stocks can convert into common stock at an initial price of $1.00 per share, contingent upon stockholder approval of a reverse stock split. The offering is expected to close on or about November 7, 2022. A.G.P./Alliance Global Partners is acting as the exclusive placement agent.
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