Intercept Pharmaceuticals, Inc. (ICPT - Free Report) announced that the FDA accepted its New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of fibrosis due to nonalcoholic steatohepatitis (NASH).
The agency also granted Priority Review to the same.
Notably, the agency generally grants priority review to drugs that have the potential to treat a serious condition and, if approved, would provide a significant improvement in safety or effectiveness.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of Mar 26, 2020, for the NDA. The agency indicated that it currently plans to hold an advisory committee meeting to discuss the application. However, the date for the meeting has not been finalized and the timeline for the review of the NDA remains subject to change.
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. Data from the study showed that OCA 25 mg demonstrated robust improvement in liver fibrosis (by ≥1 stage) with no worsening of NASH at 18 months.
A potential approval will be a significant boost for Intercept, given the market potential for patients with fibrosis due to NASH, which is expected to become the leading cause of liver transplant in the United States by 2020.
Shares of the company have lost 4.4% in the year so far against the industry’s growth of 2.2%.
Nevertheless, shares of the company gained 8.4% on Nov 25. Intercept’s shares gained on the news of the termination of CymaBay Therapeutics, Inc. (CBAY - Free Report) ’s mid-stage study of seladelpar in NASH.
CymaBay announced that the company was terminating its phase IIb study of seladelpar in subjects with NASH and its recently initiated phase II study of the drug in subjects with primary sclerosing cholangitis (PSC). Moreover, it is putting a hold on all studies of seladelpar in subjects with primary biliary cholangitis (PBC).
The decision to terminate these studies was based on initial histological findings observed in the phase IIb study of seladelpar in NASH after data showed some patients experiencing some liver damage. These planned, blinded, histological assessments of the first tranche of liver biopsies in the trial showed atypical histological findings, including histology characterized as an interface hepatitis presentation, with or without biliary injury.
Hence, Intercept is the forerunner in the challenging NASH space. Earlier, biotech bigwig Gilead Sciences, Inc. (GILD - Free Report) had suffered a setback with the failure of a late-stage study on pipeline candidate, selonsertib, in patients with compensated cirrhosis (F4) due to NASH.
Zacks Rank & A Stock to Consider
Intercept currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the same space is Alkermes, Inc., (ALKS - Free Report) which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days.
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