U.S. Markets closed
  • S&P 500

    +15.87 (+0.34%)
  • Dow 30

    -60.10 (-0.17%)
  • Nasdaq

    +72.14 (+0.45%)
  • Russell 2000

    -13.42 (-0.56%)
  • Gold

    -0.20 (-0.01%)
  • Silver

    -0.02 (-0.08%)

    -0.0006 (-0.0568%)
  • 10-Yr Bond

    -0.0150 (-0.94%)
  • Vix

    +0.48 (+2.81%)

    -0.0003 (-0.0216%)

    +0.0520 (+0.0455%)

    -284.43 (-0.52%)
  • CMC Crypto 200

    -65.80 (-4.48%)
  • FTSE 100

    -35.24 (-0.48%)
  • Nikkei 225

    +84.43 (+0.29%)

Intercept's (ICPT) NDA for NASH Drug Gets Priority Review

  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
In this article:
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.
  • Oops!
    Something went wrong.
    Please try again later.

Intercept Pharmaceuticals, Inc. ICPT 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’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 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 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.

5 Stocks Set to Double

Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.

Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.

Today, See These 5 Potential Home Runs >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Intercept Pharmaceuticals, Inc. (ICPT) : Free Stock Analysis Report
Gilead Sciences, Inc. (GILD) : Free Stock Analysis Report
Alkermes plc (ALKS) : Free Stock Analysis Report
CymaBay Therapeutics Inc. (CBAY) : Free Stock Analysis Report
To read this article on Zacks.com click here.