By RTT News,
August 11, 2014, 11:03:00 PM EDT
(RTTNews.com) - Shares of Intercept Pharmaceuticals, Inc. ( ICPT ) sky rocketed nearly 58 percent in extended trading on Monday after the clinical stage biopharmaceutical company released positive data on its investigational liver drug obeticholic acid or OCA, for the treatment of nonalcoholic steatohepatitis, or NASH.
NASH is a liver-damaging disease estimated to affect 2 to 5 percent of Americans, and there are currently few good treatment options for the disease. NASH is one of the leading causes of cirrhosis in adults in the U.S. as up to 25 percent of adults with NASH may have cirrhosis.
OCA is a bile acid analog, or a chemical substance that has a structure based on a naturally occurring human bile acid. OCA is a first-in-class product candidate that selectively binds to and induces activity in the farnesoid X receptor, or FXR, which we believe has broad liver-protective properties.
In a form 10-Q submitted to the U.S. Securities and Exchange Commission earlier in the day, the company revealed FLINT trial data that showed 46 percent of patients receiving OCA hit the study's primary histological endpoint of improved liver health, compared to 21 percent of patients receiving a placebo.
The primary endpoint was defined as a decrease in the non-alcoholic fatty liver disease or NAFLD Activity Score (NAS) of at least two points with no worsening of fibrosis.
The Phase IIb trial or FLINT trial, was a double blind, placebo-controlled trial of a once-daily dose of 25mg of OCA or placebo given for 72 weeks in 283 patients with biopsy-proven NASH.
Intercept Pharma focuses on the development and commercialization of novel bile acid therapeutics to treat chronic liver and intestinal diseases with high unmet need utilizing its proprietary bile acid chemistry.
The company released only an update on the OCA FLINT data because the complete will be presented in the fall at the American Association for the Study of Liver Disease annual meeting. The data will also be published in a medical journal.
Analysts reportedly believe that OCA has multi-billion-dollar sales potential if it gains regulatory approval and makes it to market.
Separately, the New York-based company also reported net income of $33.47 million or $1.51 per share for the second quarter, compared to a loss of $13.48 million or $0.79 per share in the prior-year quarter.
Results for the latest quarter include a $55.8 million non-cash gain recorded for the revaluation of all outstanding warrants which were exercised in April 2014.
On average, nine analysts polled by Thomson Reuters expected the company to report a loss of $0.12 per share for the quarter. Analysts' estimates typically exclude special items.
Licensing revenue for the quarter increased to $0.46 million from $0.41 million in the same quarter last year. Analysts expected revenue of $400 thousand for the quarter.
Total cost and expense nearly tripled to $22.87 million from $8.02 million, including research and development expenses of $14.92 million, up from $5.13 million, as well as general and administrative expenses of $7.96 million, up from $2.89 million last year.
ICPT closed Monday's regular trading session at $237.18, up $2.58 or 1.10% on a volume of 0.83 million shares. The stock sky rocketed a further $136.82 or 57.69% in after-hours trading.
For comments and feedback: contact email@example.com