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News Breaks
February 28, 2014
09:59 EDTOPKOPKO Health confirms orphan designation for longer-acting Factor VIIa-CTP
OPKO Health announced that the U.S. Food and Drug Administration has granted orphan drug designation to OPKO's longer-acting version of clotting Factor VIIa for the treatment of bleeding episodes in patients with hemophilia A or B with inhibitors to Factor VIII or Factor IX. Currently, Factor VIIa therapy is available only as an intravenous formulation, OPKO said. OPKO CEO Phil Frost said, "Expecting to initiate a Phase IIa trial with our IV formulation in hemophilia patients in late 2014, we believe that we are in a unique position to be first to market with a longer acting Factor VIIa product.
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July 28, 2015
13:43 EDTOPKOPKO Health announces FDA acceptance of NDA for Rayaldee
OPKO Health announced that the U.S. FDA has accepted for review OPKOs New Drug Application for calcifediol modified-release capsules, proposed trade name, Rayaldee. In the NDA, OPKO seeks approval of Rayaldee for the prevention and treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. OPKO expects written notification of NDA acceptance along with the Prescription Drug User Fee Act date in the FDAs 74-Day letter, which the company expects to receive by mid-August 2015. The NDA is supported by data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints, as previously announced.

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