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Stock Market & Financial Investment News

News Breaks
December 26, 2012
14:06 EDTOPKOPKO Health acquires Brazilian Pharmaceutical company Silcon Comercio
OPKO Health, Inc. has entered into a definitive agreement to acquire Silcon Comercio, Importacao E Exportacao de Produtos Farmaceuticos e Cosmeticos Ltda. "The acquisition allows OPKO to satisfy regulatory requirements for doing business in Brazil, which might otherwise be a prolonged process. Moreover, this platform enhances commercial synergies among our recent acquisitions and facilitates the near-term commercialization in the Brazilian market of our 4Kscore, a novel panel of biomarkers and associated algorithm to more accurately detect and grade possible prostate cancers," OPKO CEO Phillip Frost said.
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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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