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Intercept (ICPT) Down on Withdrawal of Application for NASH
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Intercept Pharmaceuticals, Inc. announced that it has formally notified the European Medicines Agency (“EMA”) of its decision to withdraw its marketing authorization application (MAA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH). The stock declined 14.87% in response to the announcement.
The MAA was initially submitted in December 2019 and was supported by the positive interim analysis results from the phase III REGENERATE study, which is ongoing.
REGENERATE is a randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of OCA clinical outcomes in patients with liver fibrosis due to NASH.
Intercept is currently in the process of generating additional efficacy and safety data from REGENERATE. This includes a full reread of month 18 biopsies using a new consensus biopsy reading approach, as well as a robust body of adjudicated safety data, to support a potential refiling in the United States.
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 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 Intercept to submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study to support potential accelerated approval. The long-term outcomes phase of the trial should continue.
Intercept has been working with the Committee for Medicinal Products for Human Use (“CHMP”) to potentially include this data in the current MAA review process. However, the established application timeline could not be extended further to allow for the submission of the additional data, which is expected in the early part of 2022. Further, based on their review of data submitted to date, the CHMP could not determine a positive benefit-risk. Hence, Intercept has decided to withdraw the MAA.
Shares of the company have slumped 41% in the year so far compared with the industry’s decline of 21.3%.
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The withdrawal comes as a setback for Intercept.
While the NASH market promises potential, it is pretty challenging as well. Quite a few companies are trying to develop drugs for this serious progressive liver disease caused by excessive fat accumulation in the organ that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. VK2809 is currently being evaluated in a phase IIb trial in patients with NASH.
During the third quarter, screening and enrollment continued at both U.S. and ex-U.S. study sites, and Viking expects to report the initial data from this trial in 2022.
Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Estimates for vTv Therapeutics have narrowed to a loss per share of 18 cents from 23 cents for 2021 and to 33 cents from 34 cents for 2022 in the past 30 days. VTVT delivered an earnings surprise of 60.12%, on average, in the last four quarters.
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Intercept (ICPT) Down on Withdrawal of Application for NASH
Intercept Pharmaceuticals, Inc. announced that it has formally notified the European Medicines Agency (“EMA”) of its decision to withdraw its marketing authorization application (MAA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH). The stock declined 14.87% in response to the announcement.
The MAA was initially submitted in December 2019 and was supported by the positive interim analysis results from the phase III REGENERATE study, which is ongoing.
REGENERATE is a randomized, double-blind, placebo-controlled, multicenter study assessing the safety and efficacy of OCA clinical outcomes in patients with liver fibrosis due to NASH.
Intercept is currently in the process of generating additional efficacy and safety data from REGENERATE. This includes a full reread of month 18 biopsies using a new consensus biopsy reading approach, as well as a robust body of adjudicated safety data, to support a potential refiling in the United States.
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 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 Intercept to submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study to support potential accelerated approval. The long-term outcomes phase of the trial should continue.
Intercept has been working with the Committee for Medicinal Products for Human Use (“CHMP”) to potentially include this data in the current MAA review process. However, the established application timeline could not be extended further to allow for the submission of the additional data, which is expected in the early part of 2022. Further, based on their review of data submitted to date, the CHMP could not determine a positive benefit-risk. Hence, Intercept has decided to withdraw the MAA.
Shares of the company have slumped 41% in the year so far compared with the industry’s decline of 21.3%.
The withdrawal comes as a setback for Intercept.
While the NASH market promises potential, it is pretty challenging as well. Quite a few companies are trying to develop drugs for this serious progressive liver disease caused by excessive fat accumulation in the organ that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. VK2809 is currently being evaluated in a phase IIb trial in patients with NASH.
During the third quarter, screening and enrollment continued at both U.S. and ex-U.S. study sites, and Viking expects to report the initial data from this trial in 2022.
Intercept currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the healthcare sector are Sarepta Therapeutics, Inc. (SRPT - Free Report) and vTv Therapeutics (VTVT - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 30 days. SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.
Estimates for vTv Therapeutics have narrowed to a loss per share of 18 cents from 23 cents for 2021 and to 33 cents from 34 cents for 2022 in the past 30 days. VTVT delivered an earnings surprise of 60.12%, on average, in the last four quarters.