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Tuesday, July 13, 2021 12:28:51 PM
Jul. 13, 2021 8:32 AM ETHepion Pharmaceuticals, Inc. (HEPA)
By: Aakash Babu, SA News Editor
Hepion Pharmaceuticals (NASDAQ:HEPA) shares fall more than 7% premarket despite announcing that its CRV431 treatment met all primary endpoints in a mid-stage trial of patients with non-alcoholic steatohepatitis ("NASH").
The study was a Phase 2a randomized, multi-center, placebo controlled, single-blind trial designed to investigate once daily oral administration of CRV431 at doses of 75 mg and 225 mg administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days.
CRV431 at both study doses was well tolerated, and there were no serious adverse events (“SAEs”), and the few adverse events (“AEs”) observed were mostly mild and unrelated to study drug, the company said.
Results showed reductions in liver transaminases, which indicate dose-related improvements in a key NASH biomarker.
Early indications of efficacy in the form of alanine aminotransferase (ALT) reductions were observed with both CRV431 dosing cohorts.
The percent ALT change from baseline to Day 28 numerically demonstrated a CRV431 versus placebo dose-response, the company said.
Recent HEPA News
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 08/07/2024 01:08:47 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/07/2024 01:04:30 PM
- Pharma Two B Announces Plans to Go Public via Merger with Hepion Pharmaceuticals, Inc. and Concurrent $11.5 Million Private Placement • GlobeNewswire Inc. • 07/22/2024 12:00:00 PM
- 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
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