Followers | 32 |
Posts | 2623 |
Boards Moderated | 0 |
Alias Born | 02/18/2005 |
![](https://investorshub.advfn.com/uicon/53156.png?cb=1636020521)
Tuesday, June 21, 2022 8:21:51 AM
Source: GlobeNewswire Inc.
Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical mid-stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to rencofilstat, a liver-targeting, orally administered, novel cyclophilin inhibitor, for the treatment of HCC.
HCC is the most common form of liver cancer, accounting for 85-90% of all cases. NASH, viral hepatitis infection, and alcohol consumption all are major causes of HCC. Worldwide, it is estimated that over 800,000 people died from liver cancer in 2020, second only to lung cancer among all cancer-related deaths.1 The high mortality is largely due to the fact that only around half of all people who develop HCC (in developed countries) receive the diagnosis early enough to have an opportunity for therapeutic intervention. Additionally, recurrence rates are high, and effective treatment options remain limited.
“Orphan Drug Designation for rencofilstat in HCC represents a significant milestone for Hepion and its recognition by the FDA of the potential for rencofilstat to address a significant unmet medical need for patients suffering from this aggressive cancer,” said Robert Foster, PharmD, PhD, Hepion’s CEO. “In addition to two Phase 2 studies in patients with NASH, we remain on track to initiate patient enrollment in a Phase 2a study of rencofilstat in HCC in the third quarter of 2022.”
The FDA's Orphan Drug Designation program provides orphan status to drugs or biologics intended for the prevention, diagnosis, or treatment of diseases that affect fewer than 200,000 people in the United States. Sponsors of medicines that are granted Orphan Drug Designation are entitled to certain incentives, including tax credits for qualified clinical trials, prescription drug user-fee exemptions, and potential seven-year marketing exclusivity upon FDA approval.
Recent HEPA News
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/21/2024 09:08:39 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 05/15/2024 08:46:12 PM
- Hepion Pharmaceuticals Initiates Wind-Down Activities in Phase 2b ‘ASCEND-NASH’ Trial • GlobeNewswire Inc. • 04/19/2024 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/16/2024 02:02:26 PM
- Hepion Pharmaceuticals Announces Exercise of Warrants for Approximately $2.0 Million Aggregate Gross Proceeds • GlobeNewswire Inc. • 02/16/2024 01:00:00 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 02/14/2024 08:38:57 PM
- Hepion Pharmaceuticals to Present at NASH-TAG 2024 • GlobeNewswire Inc. • 01/03/2024 10:15:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/03/2024 09:30:24 PM
- Hepion Pharmaceuticals Announces Restructuring Plan to Enhance Shareholder Value and Management Changes • GlobeNewswire Inc. • 12/07/2023 01:00:00 PM
- Hepion Pharmaceuticals to Present at the 7th Obesity & NASH Drug Development Summit • GlobeNewswire Inc. • 11/28/2023 09:15:00 PM
- Hepion Pharmaceuticals Announces Major Reductions in Liver Stiffness with Rencofilstat Treatment in 17-week Phase 2 Study of Advanced (F3) MASH Liver Disease • GlobeNewswire Inc. • 11/13/2023 09:05:00 PM
- Hepion Pharmaceuticals Schedules Conference Call to Review Additional Efficacy Data from Phase 2 ‘ALTITUDE-NASH’ Liver Function Trial of Rencofilstat • GlobeNewswire Inc. • 11/10/2023 01:50:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/09/2023 05:15:08 AM
- Hepion Pharmaceuticals’ Rencofilstat Demonstrates Anti-Cancer Activity in Hepatitis C-Associated Cancer Model • GlobeNewswire Inc. • 10/25/2023 12:30:00 PM
- Hepion Pharmaceuticals Announces $5.0 Million Registered Direct Offering and Concurrent Private Placement Priced At-The-Market under Nasdaq Rules • GlobeNewswire Inc. • 09/29/2023 12:00:00 PM
- Hepion Pharmaceuticals to Participate in 2023 Cantor Global Healthcare Conference • GlobeNewswire Inc. • 09/21/2023 08:05:00 PM
- New Anti-Cancer Opportunities Revealed for Hepion Pharmaceuticals’ Rencofilstat in Cancer Screening Program • GlobeNewswire Inc. • 09/21/2023 12:00:00 PM
- Hepion Pharmaceuticals Discovers Novel Rencofilstat Action in Liver Cancer • GlobeNewswire Inc. • 09/19/2023 01:00:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/18/2023 12:00:24 PM
- Rencofilstat Produces Positive Outcomes in Translational Study on Idiopathic Pulmonary Fibrosis • GlobeNewswire Inc. • 09/14/2023 12:45:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/06/2023 08:40:33 PM
- Hepion Pharmaceuticals Announces Management Changes • GlobeNewswire Inc. • 09/06/2023 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/24/2023 08:04:47 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/21/2023 08:41:16 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 07/21/2023 08:39:46 PM
Freedom Holdings Corporate Update; Announces Management Has Signed Letter of Intent • FHLD • Jul 3, 2024 9:00 AM
EWRC's 21 Moves Gaming Studios Moves to SONY Pictures Studios and Green Lights Development of a Third Upcoming Game • EWRC • Jul 2, 2024 8:00 AM
BNCM and DELEX Healthcare Group Announce Strategic Merger to Drive Expansion and Growth • BNCM • Jul 2, 2024 7:19 AM
NUBURU Announces Upcoming TV Interview Featuring CEO Brian Knaley on Fox Business, Bloomberg TV, and Newsmax TV as Sponsored Programming • BURU • Jul 1, 2024 1:57 PM
Mass Megawatts Announces $220,500 Debt Cancellation Agreement to Improve Financing and Sales of a New Product to be Announced on July 11 • MMMW • Jun 28, 2024 7:30 AM
VAYK Exited Caribbean Investments for $320,000 Profit • VAYK • Jun 27, 2024 9:00 AM