Shire Discontinues Hemophilia Gene Therapy Drug Development


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On a conference call Tuesday, Shire CEO Flemming Ornskov said that the Dublin and Lexington, MA, company has discontinued development of BAX 335, an experimental gene therapy for hemophilia B. Prior to the merger of Baxalta and Shire, Baxalta had indicated plans to move BAX 335 into Phase 3 trials, but Shire, according to a note from Leerink Partners analyst Michael Schmidt, is looking elsewhere because of the “inconsistent results” from the therapy so far. As Schmidt pointed out, in early-stage trials, BAX 335 has led to “inconsistent Factor IX activity levels and duration.”