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Risk of serious adverse events prompts data review for Revolixys

  • Shares of Regado BioSciences (RGDO) are down 38% premarket on light volume in response to its disclosure of an unplanned review of data from the Phase 3 clinical trial of its antithrombotic drug system, Revolixys Kit (previously known as REG1) by The Data Safety Monitoring Board (DSMB). The board will focus its attention on serious adverse events related to allergic reactions. Patient enrollment will cease until the DSMB completes its analysis and communicates its recommendations.
  • Regado will hold a conference call this morning to address the issue.
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