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Biotech Stock Exploding Higher After Good News On Liver Disease Drugs

Myles Udland

REUTERS/Mike Brown

Shares of Intercept Pharmaceuticals were up 50% in pre-market trade on Tuesday after the company announced development updates for several of its drug candidates.

The company, which has a market cap of more than $5 billion, also reported second quarter earnings, posting a larger than expected quarterly loss. 

Intercept is a biopharmaceutical company focused on the development of liver disease treatments.

Intercept shares, which were halted ahead of the company's announcement on Monday afternoon, were up nearly 250% year-to-date as of Monday's close, with the stock nearly quadrupling in one day on January 9 after the company stopped its FLINT trial of  obeticholic acid for the treatment of nonalcoholic steatohepatitis, or NASH, due to "early efficacy."

In its 10-Q filed with the SEC on Monday afternoon, Intercept outlined new developments for its FLINT trial. 

On Monday, the company also gave the following updates on its development programs:

  • NASH Program
    • FLINT trial data provided in 10-Q filing and to be discussed on today's conference call
    • Phase 3 program initiation anticipated in 1H 2015, pending regulatory feedback
    • Phase 2 lipid metabolism trial initiation anticipated in 1H 2015
  • PBC Program
    • Fast Track designation granted by FDA
    • Phase 3 confirmatory trial protocol finalization anticipated in 3Q 2014 and initiation planned around year-end 2014
    • Pre-NDA and pre-MAA meetings anticipated in 4Q 2014 with completed filings anticipated in 1H 2015
  • Primary Sclerosing Cholangitis (PSC) Program
    • Double-blind phase 2 trial initiation anticipated year-end 2014
    • First clinical trial of OCA in this orphan indication with high unmet medical need
  • INT-767 Phase 1 Trial Initiation Anticipated in 1H 2015

TheStreet.com's biotech reporter Adam Feuerstein broke down the results last night, writing that the rally in shares, "reflects a sence of relief that OCA head into a registration-worthy phase III study next year with less risk."   

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