We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Intercept (ICPT) Gains 12.4% in the Past Six Months: Here's Why
Read MoreHide Full Article
Shares of Intercept Pharmaceuticals, Inc. gained 12.4% in the last six months compared with the industry’s growth of 0.3%.
Image Source: Zacks Investment Research
Investors are upbeat on the performance of lead drug Ocaliva and the company’s recent pipeline progress. Last month, Intercept announced the resubmission of its new drug application (NDA) to the FDA for obeticholic acid (OCA) for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
OCA is approved under the brand name Ocaliva for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
The company is also evaluating OCA for the potential treatment of NASH.
In June 2020, Intercept received a complete response letter (“CRL”) from the FDA stating that its new drug application (NDA) for OCA for the treatment of liver fibrosis due to NASH could not be approved in its present form. The CRL indicated that the FDA has determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. This analysis was based on the data reviewed by the agency. The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue.
The resubmission is supported by two positive interim 18-month analyses from the phase III REGENERATE study in patients with pre-cirrhotic liver fibrosis due to NASH. In both REGENERATE analyses, treatment with OCA 25 mg demonstrated a statistically significant improvement in liver fibrosis by at least 1 stage without worsening of NASH—an improvement that was more pronounced in individuals with more advanced disease at baseline. Other measures of liver disease, including blood levels of liver enzymes and noninvasive measures of liver stiffness, demonstrated dose-dependent improvements after 18 and 48 months of therapy. Further, a detailed analysis of the largest safety database in NASH demonstrated a monitorable and manageable safety and tolerability profile that supports the potential chronic administration of OCA.
The company anticipates that the FDA will classify this application as a Class 2 resubmission with a PDUFA target review time of 6 months.
The successful development of OCA for NASH will give a significant boost to Intercept.
Meanwhile, concurrent with the third-quarter earnings release, the company earlier raised its sales guidance for its lead drug, Ocaliva. ICPT now expects net sales between $340 million and $350 million compared with the previous guidance of $325 million to $345 million.
Intercept Pharmaceuticals, Inc. Price and Consensus
While the NASH market promises potential with no approved therapies yet, it is challenging.
Quite a few players are trying their hand at successfully developing a treatment for the same condition.
Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) skyrocketed significantly on Dec 19 after the company announced positive top line results from the phase III MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. The study achieved both liver histological improvement endpoints as proposed by the FDA, which is likely to predict clinical benefit for supporting accelerated approval of resmetirom to treat NASH with liver fibrosis. Madrigal intends to file an NDA seeking accelerated approval of resmetirom for treating non-cirrhotic NASH with liver fibrosis.
Earlier this month, Chemomab Therapeutics, Ltd. (CMMB - Free Report) announced that its mid-stage study evaluating CM-101 in non-alcoholic steatohepatitis (NASH) patients was successful. The trial met its primary endpoint of safety and tolerability, and CM-101 achieved reductions in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments measured at baseline and at week 20. Shares of Chemomab gained on the same.
Image: Bigstock
Intercept (ICPT) Gains 12.4% in the Past Six Months: Here's Why
Shares of Intercept Pharmaceuticals, Inc. gained 12.4% in the last six months compared with the industry’s growth of 0.3%.
Image Source: Zacks Investment Research
Investors are upbeat on the performance of lead drug Ocaliva and the company’s recent pipeline progress. Last month, Intercept announced the resubmission of its new drug application (NDA) to the FDA for obeticholic acid (OCA) for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH).
OCA is approved under the brand name Ocaliva for treating primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
The company is also evaluating OCA for the potential treatment of NASH.
In June 2020, Intercept received a complete response letter (“CRL”) from the FDA stating that its new drug application (NDA) for OCA for the treatment of liver fibrosis due to NASH could not be approved in its present form. The CRL indicated that the FDA has determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH. This analysis was based on the data reviewed by the agency. The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue.
The resubmission is supported by two positive interim 18-month analyses from the phase III REGENERATE study in patients with pre-cirrhotic liver fibrosis due to NASH. In both REGENERATE analyses, treatment with OCA 25 mg demonstrated a statistically significant improvement in liver fibrosis by at least 1 stage without worsening of NASH—an improvement that was more pronounced in individuals with more advanced disease at baseline. Other measures of liver disease, including blood levels of liver enzymes and noninvasive measures of liver stiffness, demonstrated dose-dependent improvements after 18 and 48 months of therapy. Further, a detailed analysis of the largest safety database in NASH demonstrated a monitorable and manageable safety and tolerability profile that supports the potential chronic administration of OCA.
The company anticipates that the FDA will classify this application as a Class 2 resubmission with a PDUFA target review time of 6 months.
The successful development of OCA for NASH will give a significant boost to Intercept.
Meanwhile, concurrent with the third-quarter earnings release, the company earlier raised its sales guidance for its lead drug, Ocaliva. ICPT now expects net sales between $340 million and $350 million compared with the previous guidance of $325 million to $345 million.
Intercept Pharmaceuticals, Inc. Price and Consensus
Intercept Pharmaceuticals, Inc. price-consensus-chart | Intercept Pharmaceuticals, Inc. Quote
While the NASH market promises potential with no approved therapies yet, it is challenging.
Quite a few players are trying their hand at successfully developing a treatment for the same condition.
Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) skyrocketed significantly on Dec 19 after the company announced positive top line results from the phase III MAESTRO-NASH biopsy clinical trial of resmetirom, a liver-directed selective thyroid hormone receptor agonist. The study achieved both liver histological improvement endpoints as proposed by the FDA, which is likely to predict clinical benefit for supporting accelerated approval of resmetirom to treat NASH with liver fibrosis. Madrigal intends to file an NDA seeking accelerated approval of resmetirom for treating non-cirrhotic NASH with liver fibrosis.
Earlier this month, Chemomab Therapeutics, Ltd. (CMMB - Free Report) announced that its mid-stage study evaluating CM-101 in non-alcoholic steatohepatitis (NASH) patients was successful. The trial met its primary endpoint of safety and tolerability, and CM-101 achieved reductions in secondary endpoints that include a range of liver fibrosis biomarkers and physiologic assessments measured at baseline and at week 20. Shares of Chemomab gained on the same.
Intercept currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rack (Strong Buy) stocks here.