MIAMI--(BUSINESS WIRE)--OPKO Health, Inc. (NYSE:OPK), a multi-national biopharmaceutical and diagnostics company, today reported operating and financial results for its second quarter ended June 30, 2014.
Business Highlights
* Rayaldee Meets Primary Endpoints in First Pivotal Phase 3 Trial; NDA Submission on Track for Q4 2014: OPKO announced successful top-line results from the first pivotal Phase 3 trial of Rayaldee. This trial is one of two identical randomized, double-blind, placebo-controlled, multi-site studies intended to establish the safety and efficacy of Rayaldee as a new treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. OPKO to announce top line results from the second Phase 3 trial in September 2014 and is on track to submit a New Drug Application (NDA) with the United States (U.S.) Food and Drug Administration (FDA) in the fourth quarter of 2014.
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