Intercept Pharmaceuticals (ICPT) Receives Accelerated Approval From FDA for Ocaliva

Shares of Intercept Pharmaceuticals (ICPT) were up +9.23 or +6.51 percent to $151.00 per share in Tuesday’s premarket after the company was granted accelerated approval by the FDA for Ocaliva or obeticholic acid, in combination with ursodeoxycholic or UDCA for treating primary biliary cholangitis or PBC.  Intercept Pharmaceutical stock closed at $141.77, up +4.04 or +2.93 percent in Friday’s regular trading session.

Stock Analysis

New York City based Intercept Pharmaceuticals was founded in 2002 and is a biopharmaceutical company specializing in developing and commercializing new treatments for chronic liver disease, such as primary biliary cirrhosis. The company’s main product is obeticholic acid or OCA, a substance structurally akin to naturally occurring human bile acid. The drug, which is a first in its class, selectively binds and activates “farnesoid X receptors” or FXRs that the company believes has protective properties for the liver. The company had its initial public offering on October 16^th of 2012 at $15 per share with a subsequent offering of $33 per share on June 24^th, 2013.

Intercept announced late Friday that the FDA had granted accelerated approval for Ocaliva combined with UDCA in adults with inadequate response to UDCA or as a monotherapy for adult patients with intolerance to UDCA in the treatment of primary biliary cholangitis. Primary biliary cholangitis was formally known as primary biliary cirrhosis.

The accelerated approval by the FDA was granted based on a reduction of alkaline phosphatase or ALP, which is an important market of liver damage. The FDA’s continued approval for the indication may be contingent on the verification and description of the clinical benefits of the treatment in confirmatory trials since improvements in survival or disease related symptoms has not yet been established.

Chief Executive Officer and President of Intercept Mark Pruzanski, M.D., said in the company’s press release that, “Intercept was founded on the belief that targeting FXR would benefit patients with liver diseases for which there are limited or no treatment options, and Ocaliva’s approval marks the culmination of more than a decade of work. We are very pleased that the FDA has approved Ocaliva for PBC and would like to thank all the patients and investigators around the world who participated in our clinical trials to make this possible.”

PBC patients in the United States will be able to obtain Ocaliva within 7 to 10 days and will be distributed by a specialty pharmacy network. People with PBC will be able to access Ocaliva through Interconnect, a new personalized patient support services program, which will also provide education and treatment support for eligible patients.

In addition to PBC, obeticholic acid is also being studied to treat nonalcoholic steatohepatitis or NASH, a liver condition associated with obesity and is more common than PBC. Analysts expect the worldwide market for NASH could be between $5 billion and $10 billion with some analyst projecting sales of obeticholic acid to reach as much as $1.6 billion by 2020.

Other News About ICPT

Intercept Announces Ocaliva™ (Obeticholic Acid) Data in PBC to be Presented at DDW 2016

Company presented its findings at the Digestive Disease Week in San Diego last week.

Intercept (ICPT) Q1 Loss Narrower than Expected, Sales Lag

Company reported a loss of -$3.33 per share in the first quarter.

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