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Here's Why Hepion Pharma (HEPA) is Up More Than 80% in Two Days
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Hepion Pharmaceuticals (HEPA - Free Report) has risen 80.6% since it announced positive top-line data from the phase II liver function study on its lead drug candidate, rencofilstat earlier this week.
On Monday, the company announced that rencofilstat demonstrated improvements in physiologic liver function and key non-alcoholic steatohepatitis (NASH) biomarkers in the phase II ALTITUDE-NASH study in advanced patients (with stage 3 or greater fibrosis).
The study met its primary efficacy endpoint by demonstrating improved physiologic liver function. The data showed that four measures of impairment significantly improved on treatment with rencofilstat 225 mg for four months in advanced NASH patients.
The study also met all secondary endpoints, including reductions in liver injury-associated biomarkers and multiple fibrosis-associated biomarkers following four months of treatment with rencofilstat. The greatest reductions in NASH biomarkers were observed in the 225 mg dose in high-risk population. The drug was safe and well tolerated after four months of treatment.
The study data builds on Hepion Pharmaceuticals’ earlier positive data from a smaller phase IIa study on rencofilstat, the company said. In fact, management is now more confident of positive outcomes in the larger and longer phase IIb ASCEND-NASH biopsy study, which is currently recruiting patients.
Hepion Pharmaceuticals’ stock has risen 166.9% this year so far against a decrease of 6.5% for the industry.
Image Source: Zacks Investment Research
Please note that rencofilstat is a potent inhibitor of cyclophilins and enjoys Fast Track designation and Orphan Drug designation by the FDA for NASH.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. The NASH market promises potential with no approved therapies. The area has been in the news of late.
Madrigal Pharmaceuticals (MDGL - Free Report) is developing resmetirom for treating patients with NASH with liver fibrosis. Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH. Madrigal expects to file a new drug application (NDA) for resmetirom in the second quarter of 2023. The drug also recently received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis.
Earlier this month, Viking Therapeutics (VKTX - Free Report) announced positive top-line results from its phase IIb clinical study of VK2809 in patients with biopsy-confirmed NASH. The study achieved its primary endpoint. Patients treated with VK2809 experienced statistically significant reductions in liver fat content from baseline to week 12 compared with placebo.
VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol, triglycerides and atherogenic lipoproteins compared with placebo. Viking Therapeutics plans to report 52-week biopsy data from the VOYAGE study in the first half of next year.
However, this week, FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting voted against the approval of Intercept Pharmaceuticals’ NDA seeking approval for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to NASH on concerns about drug-induced liver injury. The FDA is scheduled to give its decision on Intercept’s NDA on Jun 22, 2023.
Zacks Rank
Hepion Pharmaceuticals currently has a Zacks Rank #4 (Sell).
Image: Bigstock
Here's Why Hepion Pharma (HEPA) is Up More Than 80% in Two Days
Hepion Pharmaceuticals (HEPA - Free Report) has risen 80.6% since it announced positive top-line data from the phase II liver function study on its lead drug candidate, rencofilstat earlier this week.
On Monday, the company announced that rencofilstat demonstrated improvements in physiologic liver function and key non-alcoholic steatohepatitis (NASH) biomarkers in the phase II ALTITUDE-NASH study in advanced patients (with stage 3 or greater fibrosis).
The study met its primary efficacy endpoint by demonstrating improved physiologic liver function. The data showed that four measures of impairment significantly improved on treatment with rencofilstat 225 mg for four months in advanced NASH patients.
The study also met all secondary endpoints, including reductions in liver injury-associated biomarkers and multiple fibrosis-associated biomarkers following four months of treatment with rencofilstat. The greatest reductions in NASH biomarkers were observed in the 225 mg dose in high-risk population. The drug was safe and well tolerated after four months of treatment.
The study data builds on Hepion Pharmaceuticals’ earlier positive data from a smaller phase IIa study on rencofilstat, the company said. In fact, management is now more confident of positive outcomes in the larger and longer phase IIb ASCEND-NASH biopsy study, which is currently recruiting patients.
Hepion Pharmaceuticals’ stock has risen 166.9% this year so far against a decrease of 6.5% for the industry.
Image Source: Zacks Investment Research
Please note that rencofilstat is a potent inhibitor of cyclophilins and enjoys Fast Track designation and Orphan Drug designation by the FDA for NASH.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death. The NASH market promises potential with no approved therapies. The area has been in the news of late.
Madrigal Pharmaceuticals (MDGL - Free Report) is developing resmetirom for treating patients with NASH with liver fibrosis. Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH. Madrigal expects to file a new drug application (NDA) for resmetirom in the second quarter of 2023. The drug also recently received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis.
Earlier this month, Viking Therapeutics (VKTX - Free Report) announced positive top-line results from its phase IIb clinical study of VK2809 in patients with biopsy-confirmed NASH. The study achieved its primary endpoint. Patients treated with VK2809 experienced statistically significant reductions in liver fat content from baseline to week 12 compared with placebo.
VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol, triglycerides and atherogenic lipoproteins compared with placebo. Viking Therapeutics plans to report 52-week biopsy data from the VOYAGE study in the first half of next year.
However, this week, FDA’s Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting voted against the approval of Intercept Pharmaceuticals’ NDA seeking approval for obeticholic acid for the treatment of pre-cirrhotic fibrosis due to NASH on concerns about drug-induced liver injury. The FDA is scheduled to give its decision on Intercept’s NDA on Jun 22, 2023.
Zacks Rank
Hepion Pharmaceuticals currently has a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.