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Intercept Pharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update
Positive results from pivotal Phase 3 REGENERATE study of OCA in patients with liver fibrosis due to NASH
New Drug Application (NDA) filing in the U.S. for OCA in NASH projected in the third quarter of 2019
Worldwide Ocaliva net sales of $51.8 million in the first quarter of 2019 representing 47% growth versus the prior year quarter
Increasing 2019 Ocaliva net sales guidance range to between $235 and $245 million
Updating 2019 non-GAAP adjusted operating expenses guidance range to between $470 and $500 million in connection with acceleration of NASH NDA filing and launch preparation activities
Conference call scheduled for 8:30 a.m. ET today
NEW YORK, May 8, 2019 – Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced its financial results for the quarter ended March 31, 2019.
“Our Phase 3 REGENERATE readout demonstrating OCA’s anti-fibrotic benefit in patients with NASH has been a watershed moment for the liver community and underscores our unique competitive opportunity to become the first approved NASH therapy,” said Mark Pruzanski, M.D., President and Chief Executive Officer of Intercept. “I’m very pleased with the acceleration of our NASH NDA filing and launch preparations, as well as our continued strong commercial performance in PBC resulting in our increased 2019 Ocaliva net sales guidance.”
OCA in NASH
In February 2019, we announced positive topline results from the pivotal Phase 3 REGENERATE study demonstrating that once-daily obeticholic acid (“OCA”) 25 mg met the primary endpoint of ‘fibrosis improvement by at least one stage with no worsening of NASH’ in the planned 18-month interim analysis with high statistical significance (p=0.0002 vs placebo). Adverse events were generally mild-to-moderate in severity and the most common were consistent with the known profile of OCA. In April 2019, additional supportive REGENERATE data were presented during the Opening Ceremony of the International Liver Congress™ 2019, the 54th Annual Meeting of the European Association for the Study of the Liver (“EASL”). The data presented at EASL showed that OCA demonstrated robust efficacy across a range of additional histologic and biochemical parameters.
The following information was filed by on Wednesday, May 8, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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