Intercept Pharmaceuticals, Inc. (ICPT - Free Report) announced that it has completed patient enrollment in the phase III REVERSE study, currently evaluating obeticholic acid (OCA) for the treatment of compensated cirrhosis due to nonalcoholic steatohepatitis (NASH).
This double-blind, placebo-controlled study is examining the safety and efficacy of OCA in the given patient population. The primary endpoint of the study is to see the percentage of patients with histological improvement in fibrosis by at least one stage with no worsening of NASH following 18 months of treatment with the NASH Clinical Research Network scoring system.
Shares of Intercept have declined 22.5% in the past year compared with the industry’s decrease of 5.9%.
In November 2019, Intercept announced that the FDA accepted its NDA for OCA seeking accelerated approval for the treatment of fibrosis due to NASH. The regulatory agency also granted priority review and set an action date of Mar 26, 2020 for the NDA.
The NDA filing for OCA is supported by positive interim analysis results from the pivotal phase III REGENERATE study in patients with liver fibrosis due to NASH.
Last month, the marketing application for OCA was submitted to the European Medicines Agency (EMA) for treating fibrosis due to NASH.
Simultaneously, Intercept also announced that the FDA tentatively scheduled the advisory committee meeting (AdCom) on Apr 22, 2020 related to the NDA for OCA to treat liver fibrosis due to NASH. The company believes that the FDA will extend the Prescription Drug User Fee Act (PDUFA) target action date for Intercept’s NDA, earlier set for Mar 26, 2020.
We remind investors that OCA is already approved under the brand name Ocaliva for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as a monotherapy for adults intolerant to UDCA. The drug generated sales of $179.3 million in the first nine months of 2019, reflecting a surge of 43.5% year over year.
A chronic liver disease, NASH, is caused by excessive fat accumulation in the liver or steatosis. The ailment is anticipated to be the leading cause for liver transplantation by 2020. Hence, a potential approval of OCA for NASH will significantly boost Intercept’s prospects, given the market opportunity the product can grab in absence of any approved medicine for addressing NASH.
Zacks Rank & Stocks to Consider
Intercept currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) , Denali Therapeutics Inc. (DNLI - Free Report) and Kala Pharmaceuticals, Inc. (KALA - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Repligen’s earnings estimates have been revised 0.9% upward for 2020 over the past 60 days. The stock has soared 78.4% in the past year.
Denali’s loss per share estimates have narrowed 0.4% for 2020 over the past 60 days. The stock has surged 31.1% in the past year.
Kala Pharmaceuticals’ loss per share estimates have narrowed 0.9% for 2020 over the past 60 days. The stock has rallied 17.8% in the past year.
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