Opko Health Inc (OPK)

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Rayaldee P3 trial ended in July and Frost kept buying after. Good sign!

May 2014: Third phase 3 trial of Rayaldee initiated, designed to evaluate long-term safety and efficacy in treating secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. This phase 3 trial is a 6-month open-label extension of two ongoing RCTs (n=approximately 430). Both ongoing trials will end in July 2014 and top-line data are expected during Q3 2014. In the open-label extension study, patients either continue RAYALDEE treatment or switch to RAYALDEE from placebo treatment. Additional patients will be allowed to enroll in the open-label extension study after leaving the blinded pivotal trials. The endpoints of all three phase 3 studies include vitamin D status and changes in plasma intact parathyroid hormone (PTH), serum calcium and serum phosphorus. [4