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January 7, 2013
17:37 EDTICPTIntercept Pharmaceuticals initiates Phase 2 NASH tiral of OCA in Japan
Intercept Pharmaceuticals announced that its partner Dainippon Sumitomo Pharma, or DSP, has initiated a phase 2 clinical trial of obeticholic acid, or OCA, in adult nonalcoholic steatohepatitis, or NASH, patients in Japan. The trial is studying the efficacy and safety of a once daily dose of OCA, with the goal of randomizing 200 NASH patients to receiving OCA or placebo. The primary endpoint will be evaluated by histological improvement. DSP expects to complete the trial in the first half of 2016.
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January 22, 2015
07:17 EDTICPTIntercept price target lowered to $300 from $500 at Deutsche Bank
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January 12, 2015
08:13 EDTICPTIntercept plans to initiate PSC Program Biliary Atresia Phase in 2H15
Intercept provided a clinical update on obeticholic acid, or OCA, a novel bile acid analog and first-in-class agonist of the farnesoid X receptor, or FXR, as well as planned 2015 milestones and other general business updates. OCA is currently being developed for the treatment of several chronic liver diseases, including primary biliary cirrhosis, or PBC, nonalcoholic steatohepatitis, or NASH, and primary sclerosing cholangitis, or PSC. The completion of PBC Program NDA and MAA filings planned in 1H15. The NASH Program Phase 3 program initiation planned in 1H15 and Japan Phase 2 trial data expected at the end of 2015. The PSC Program Biliary Atresia: Phase 2 initiation planned in 2H15 and INT-767: Phase 1 initiation planned for the end of 2015. Intercept ended 2014 with approximately $240M in cash and investments. For FY15, the company projects adjusted operating expenses in the range of $180M-$200M, which excludes stock-based compensation and other non-cash items. These expenses will support the clinical development program for OCA in PBC, NASH and PSC, expansion of our clinical, regulatory, medical affairs and commercial infrastructure in the United States and Europe, expansion of OCA manufacturing activities, as well as advancement of INT-767 and other preclinical pipeline programs. Adjusted operating expense, as presented above, is a non-GAAP financial measure. The company anticipates that stock-based compensation expense will represent the most significant non-cash item that is excluded in adjusted operating expenses as compared to operating expenses under GAAP.

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