Associated tags: HDV, Fast Track, Cyclophilin, Food, HBV, NASH, HCV, Cirrhosis, Orphan drug, HCC, Terminal, Liver disease, HEPA, Fatty liver disease, Artificial intelligence, Conditional sentence, Pharmaceutical industry, Doctor of Philosophy, Hepatocellular carcinoma, Patient
Locations: NEW YORK, MA, UTAH, CALIFORNIA, LA JOLLA, ML, EDISON, NJ, US, PENNSYLVANIA, NO, UNITED STATES
ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of rencofilstat dosed for 12 months, with a target enrollment of 336 subjects.
Key Points:
- ASCEND-NASH is a Phase 2b, randomized, multi-center, double-blinded study with first patient screened in August 2022, to evaluate the safety and efficacy of rencofilstat dosed for 12 months, with a target enrollment of 336 subjects.
- To date, approximately 80 subjects have completed their Day 365 visits and are evaluable for both safety and efficacy.
- “We are disappointed to announce the wind-down of our Phase 2 NASH trial, which we attribute entirely to resource constraints,” said John Brancaccio, Executive Chairman of Hepion.
- There were no safety concerns observed for rencofilstat in the ASCEND-NASH trial.”
Acquisition,
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Conditional sentence,
HEPA,
IME Group,
Certified Public Accountant,
Business administration,
Lehigh University,
Fatty liver disease,
American Institute,
Drexel University EDISON, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, and other chronic diseases, today announced the appointment of Michael Purcell to the Company’s Board of Directors, effective March 5, 2024.
Key Points:
- EDISON, N.J., March 06, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, and other chronic diseases, today announced the appointment of Michael Purcell to the Company’s Board of Directors, effective March 5, 2024.
- Mr. Purcell has more than 37 years of professional experience with Deloitte & Touche LLP, serving as a consultant from 2015 to 2017 and an Audit Partner from 1979 until 2015.
- Mr. Purcell also currently serves as a financial advisor to several emerging growth companies.
- Mr. Purcell has worked on a number of company boards and has served on the Board of Directors of CFG Bank since 2016, the Board of Directors of Hyperion Bank since 2018, and the Board of Directors of International Money Express, Inc. since 2018.
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Friday, February 16, 2024
The resale of the shares of common stock issuable upon exercise of the warrant were registered pursuant to an effective registration statement on Form S-1 (No.
Key Points:
- The resale of the shares of common stock issuable upon exercise of the warrant were registered pursuant to an effective registration statement on Form S-1 (No.
- In consideration for the immediate exercise of the existing warrant for cash, Hepion has agreed to issue to the investor two new unregistered warrants, each to purchase 735,295 shares of common stock (or an aggregate of 1,470,590 shares) at an exercise price of $1.91 per share.
- Such warrants are identical, except that one warrant has a term of five years and the second warrant has a term of eighteen months.
- Hepion intends to use the net proceeds from the exercise for general corporate purposes.
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Wednesday, January 3, 2024
EDISON, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that an abstract highlighting its lead drug candidate, rencofilstat, will be presented at the 2024 NASH-TAG Conference, which is being held January 4-6, 2024, in Park City, Utah.
Key Points:
- EDISON, N.J., Jan. 03, 2024 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that an abstract highlighting its lead drug candidate, rencofilstat, will be presented at the 2024 NASH-TAG Conference, which is being held January 4-6, 2024, in Park City, Utah.
- Title: Hepatic Functional Improvement Detected by HepQuant DuO within 120 Days of Treatment with Rencofilstat in MASH Subjects with ≥F3 Fibrosis.
- A copy of the presentation materials will be accessible on the Company’s website at www.hepionpharma.com under “Publications” in the Pipeline section.
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Thursday, December 7, 2023
HEPA,
NASH,
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Acquisition,
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Disclosure,
Clinical trial,
Artificial intelligence,
Fatty liver disease,
Investment,
Patient,
Pharmaceutical industry EDISON, N.J., Dec. 07, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that its Board of Directors has approved a strategic restructuring plan with the objective of preserving capital by initially reducing operating costs by approximately 60% going forward. As a result, Hepion will incur a one-time restructuring charge of approximately $400 – $800 thousand that will be recorded in the fourth quarter of 2023.
Key Points:
- As a result, Hepion will incur a one-time restructuring charge of approximately $400 – $800 thousand that will be recorded in the fourth quarter of 2023.
- Additionally, the Company has initiated a process to explore a range of strategic and financing alternatives focused on maximizing stockholder value within the current financial environment and NASH drug development landscape.
- Currently 131 patients are being treated in our Phase 2b (“ASCEND-NASH”) clinical trial.
- Robert is leaving for personal reasons, and we wish him all the best,” commented Gary S. Jacob, Ph.D., Chairman of the Hepion Board.
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Tuesday, November 28, 2023
HEPA,
NASH,
Drug development,
Multiomics,
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Doctor of Philosophy,
Obesity,
Artificial intelligence,
AI,
Fatty liver disease,
Machine learning,
Medical device EDISON, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it will present at the 7th Obesity & NASH Drug Development Summit taking place November 27 – 29, 2023 in Boston.
Key Points:
- EDISON, N.J., Nov. 28, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced that it will present at the 7th Obesity & NASH Drug Development Summit taking place November 27 – 29, 2023 in Boston.
- Scott Campbell, PhD, Hepion’s Quantitative Translational Pharmacologist, will deliver an oral presentation on the use of AI / machine learning (“ML”) to enrich NASH clinical trials and for NASH patient selection; and the use of multi-omics with ML for biomarker response prediction.
- Using AI/ML and Multi-Omics to Determine Efficacy for Clinical NASH Study Enrichment: Highlights from Recently Completed Phase 2 Trials with Rencofilstat
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Monday, November 13, 2023
Hepatology,
Hyaluronic acid,
Safety,
Conditional sentence,
ACE,
ALT,
AASLD,
Physician,
Disease,
Risk,
Artificial intelligence,
Clinical trial,
Liver disease,
Cirrhosis,
KPA,
Collagen,
Liver,
TIMP1,
HEPA,
Fibrosis,
Drug,
Doctor of Philosophy,
MASH,
Patient,
ELF,
F4,
Medical imaging,
Pharmaceutical industry,
Dietary supplement,
F3 EDISON, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”; previously referred to as “NASH”), fibrotic diseases, hepatocellular carcinoma (“HCC”), and other chronic diseases, today announced additional efficacy data for rencofilstat, its lead drug candidate.
Key Points:
- Dr. Mayo’s presentation indicated that 17 weeks of rencofilstat treatment was associated with significant reduction in liver stiffness (FibroScan®) in MASH subjects with advanced F3, an outcome suggesting reduction in hepatic fibro-inflammation.
- Ongoing hepatic fibro-inflammation leads to progressive accumulation of collagen or fibrosis, increasing liver stiffness, and functional deterioration.
- The predictive power of liver stiffness measurements on the course of disease is further enhanced when taken together with blood-based markers of liver disease.
- Reduction in liver stiffness by rencofilstat likely indicates reduction in fibroinflammation, and reduction in risk for subsequent clinical outcome.
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Friday, November 10, 2023
Hepatology,
Conditional sentence,
AASLD,
Artificial intelligence,
Clinical trial,
Fatty liver disease,
Liver,
HEPA,
Clinical pharmacology,
Doctor of Philosophy,
Pharmaceutical industry,
Boston Hepion is pleased to invite all interested parties to participate in a conference call at 4:30 p.m.
Key Points:
- Hepion is pleased to invite all interested parties to participate in a conference call at 4:30 p.m.
- ET on November 13, 2023, during which the additional ALTITUDE-NASH efficacy data will be discussed.
- To participate in this conference call, please dial (800) 715-9871 (U.S.) or (646) 307-1963 (international), conference ID 8619177, approximately 10 minutes prior to the start time.
- The call will also be broadcast live and archived on the Company’s website at www.hepionpharma.com under “Events” in the Investors section.
Retrieved on:
Wednesday, October 25, 2023
Liver,
Neoplasm,
HCC,
Mouse,
Health,
Conditional sentence,
Virus,
Sofosbuvir,
Artificial intelligence,
Scripps Research,
Growth,
Liver cancer,
HCV,
Fatty liver disease,
DRS,
Velpatasvir,
HEPA,
Cancer,
Pharmaceutical industry,
Medical imaging,
Dietary supplement The study was published in the peer-reviewed, open access scientific journal, Viruses, and was conducted by Drs.
Key Points:
- The study was published in the peer-reviewed, open access scientific journal, Viruses, and was conducted by Drs.
- Winston Stauffer, Philippe Gallay, and colleagues at The Scripps Research Institute (La Jolla, California).
- Sofosbuvir, velpatasvir and rencofilstat treatments initiated at week 16 all eliminated HCV infection.
- Not only could rencofilstat have an enormous impact on human health, but the investment growth opportunities associated with treating these high-need, global-scale diseases are equally large.”
Hepion recently announced a new mechanism by which rencofilstat exerts anti-cancer activity in liver cancer and the drug’s anti-cancer activity in numerous cell lines representing 86% of cancer types.
Retrieved on:
Friday, September 29, 2023
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Fatty liver disease,
Form,
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Security (finance) The closing of the registered direct offering and the concurrent private placement is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions.
Key Points:
- The closing of the registered direct offering and the concurrent private placement is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions.
- A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.
- The gross proceeds to Hepion from the offering are expected to be approximately $5.0 million, before deducting the placement agent’s fees and other offering expenses payable by Hepion.
- A final prospectus supplement and accompanying prospectus relating to the registered direct offering will be filed with the SEC.
