Shares of Intercept Pharmaceuticals were up more than 65% in after hours trade on Monday after the company announced development updates for several of its drug candidates.
The company, which has a market cap of more than $US5 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, 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:
- 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
- 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
On Twitter following the announcement, TheStreet.com’s Adam Feuerstein broke down the results, adding that one “large” Intercept shareholder told him he expects the stock to gain $US50-$100 on the results.
As of 5:15 pm ET, the stock was up $US124.82, or 52.63%, to $US362.00 after closing at $US237.18 on Monday.
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