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March 10, 2014
07:17 EDTOMEROmeros announces data using OMS721 in patients with aHUS
Omeros Corporation announced positive data using OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 program, in ex vivo studies of endothelial activation relevant to the pathophysiology of human atypical hemolytic uremic syndrome, a form of thrombotic microangiopathy. In February, Omeros reported positive results from its OMS721 Phase 1 clinical trial and, earlier this month, announced submission of an investigational new drug application to the U.S. Food and Drug Administration to initiate a Phase 2 clinical trial in patients with TMA, including patients with aHUS. The data announced resulted from studies conducted in support of the clinical evaluation of OMS721 by Prof. Giuseppe Remuzzi and colleagues Marina Noris and Miriam Galbusera at the Mario Negri Institute for Pharmacological Research in Bergamo, Italy, and the Clinical Research Center for Rare Diseases "Aldo e Cele Daccò" of the same Institute, a European center for collecting and studying TMA samples.
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May 22, 2015
07:10 EDTOMEROmeros receives positive opinion from EMA's committee for Omidria
Omeros announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for Omidria 1%/0.3%. Omidria is used during cataract surgery and other intraocular lens replacement procedures to maintain mydriasis, prevent miosis, and reduce postoperative eye pain. Cataract surgery and IOL replacement are among the most common surgical procedures worldwide, with approximately 3.9 million of them expected to be performed in Western Europe alone in 2015. Omidria was approved by the FDA in 2014 and last month was made broadly available nationwide for commercial use.
May 11, 2015
16:40 EDTOMEROmeros reports Q1 EPS (51c), consensus (63c)
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