On June 16, 2014, DARA BioSciences, Inc. (DARA) announced that the U.S. Food and Drug Administration (FDA) had granted Orphan Drug Designation (ODD) to KRN5500 for the treatment of multiple myeloma (MM). This is the second such award for the drug following the company's announcement in late February 2014 that the agency granted Orphan Drug Designation to KRN5500 for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy (CCIPN) that is refractory to conventional analgesics.
We believe this is very positive news for the company. The application was approved on first cycle review by the agency, with data supporting the application largely taken from early-stage trials and a comprehensive publication in 2012 which we discuss below. We see...
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