Intercept Pharmaceuticals, Inc. ICPT announced that the FDA has postponed the advisory committee meeting (AdCom), which was scheduled on Jun 9, 2020 regarding the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of liver fibrosis due to nonalcoholic steatohepatitis (NASH).
Per the press release, this delay will accommodate the review of additional data requested by the regulatory body, which Intercept plans to submit within the next week. The FDA will issue a new proposed AdCom date in the future.
Earlier, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Jun 26, 2020 for the completion of the review of the NDA seeking approval of OCA for liver fibrosis due to NASH. The company now expects this date to get extended as well.
Shares of Intercept have plunged 35% so far this year against the industry’s increase of 7.9%.
We remind investors that 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 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.
In December 2019, the marketing application for OCA was submitted to the European Medicines Agency (EMA) for treating fibrosis due to NASH.
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 $72.7 million in the first quarter of 2020, reflecting a surge of 39% 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 in the days ahead.
We note that Intercept’s rival Genfit GNFT also announced disappointing results from a late-stage NASH study. Last year, biotech bigwig Gilead Sciences, Inc.’s GILD candidate also failed in a late-stage study involving patients afflicted with compensated cirrhosis (F4) due to NASH.
Zacks Rank & Key Pick
Intercept currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Akcea Therapeutics, Inc. AKCA, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Akcea Therapeutics’ loss per share estimates have narrowed 33.8% for 2020 and 24.8% for 2021 over the past 60 days.
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