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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