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Europe's COMP gives thumbs up to Orphan Drug status for Dyax's DX-2930; shares up 11%

Sep. 30, 2015 11:45 AM ETDyax Corp. (DYAX) StockBy: Douglas W. House, SA News Editor1 Comment
  • European regulators give (NASDAQ:DYAX +11.1%) some added oomph today. The European Medicines Agency's Committee for Orphan Medicinal Products (COMP) adopts a positive opinion recommending Orphan Drug status to DX-2930 for the treatment of hereditary angioedema (HAE), a rare, potentially life-threatening disorder characterized by periodic attacks of swelling in the face, extremities, genitals, GI tract and upper airways.
  • Orphan Drug-tagged medicines in the EU enjoy a 10-year period of market exclusivity, if approved.
  • DX-2930, currently in Phase 2 development, is an investigational fully human monoclonal antibody that inhibits plasma kallikrein, an enzyme that activates several blood coagulation factors and plasminogen, a protein in the blood that degrades many blood plasma proteins, including fibrin clots.
  • Previously, the FDA designated DX-2930 an Orphan Drug and Breakthrough Therapy for Fast Track Review.

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